A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk (ACHIEVE-4)
April 16, 2026 updated by: Eli Lilly and Company
A Phase 3, Open-Label Study of Once Daily LY3502970 Compared With Insulin Glargine in Adult Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk
The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk.
The study will last approximately 2 years may include up to 27 visits.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2749
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, 1407
- CEMEDIC
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Buenos Aires, Argentina, C1440AAD
- CENUDIAB
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Buenos Aires, Argentina, C1120AAC
- Centro Médico Viamonte
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Buenos Aires, Argentina, 1061
- Buenos Aires Macula S.A
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Buenos Aires, Argentina, 1425
- Cardiología Palermo
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Buenos Aires, Argentina, C1061AAS
- CIPREC
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Buenos Aires, Argentina, C1425AGC
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
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Buenos Aires, Argentina, 1417
- Centro Privado de Medicina Familiar / Mindout Research
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Buenos Aires, Argentina, C1128AAF
- Mautalen Salud e Investigacion
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Buenos Aires, Argentina, C1430CKE
- Glenny Corp. S.A.
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CABA, Argentina, C1015ABO
- Organizacion Medica de Investigacion
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Córdoba, Argentina, 5000
- Hospital San Roque
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Granadero Baigorria, Argentina, 2152
- Centro de Investigaciones Clínicas Baigorria
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Lujan de Cuyo, Argentina, 5509
- Polo de Salud Vistalba
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Rosario, Argentina, 2000
- Instituto Médico Catamarca IMEC
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San Miguel de Tucumán, Argentina, 4000
- Investigaciones Clinicas Tucuman
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Braunau am Inn, Austria, 5280
- Krankenhaus St. Josef Braunau
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Feldkirch, Austria, 6800
- VIVIT
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Graz, Austria, 8036
- Medizinische Universitat Graz
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Linz, Austria, 4021
- Konventhospital der Barmherzigen Brüder Linz
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Sankt Stefan ob Stainz, Austria, 8511
- Private Practice - Dr. Evelyn Fliesser-Gorzer
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Vienna, Austria, 1030
- Klinik Landstraße
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Vienna, Austria, 1060
- Zentrum für klinische Studien Dr Hanusch Gmbh
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Vienna, Austria, 1090
- Universitaetsklinikum Allgemeines Krankenhaus Wien
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Vienna, Austria, 1130
- Klinik Hietzing
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Acaraju, Brazil, 49055-530
- Centro de Pesquisa Clinica do Coracao
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Brasília, Brazil, 71681-603
- Hospital Brasilia
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Brasília, Brazil, 71625-175
- Centro de Pesquisa Clinica do Brasil
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Campinas, Brazil, 13060-080
- Instituto de Pesquisa Clinica de Campinas
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Campinas, Brazil, 13060-803
- Centro de Pesquisa Sao Lucas
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Campinas, Brazil, 13092-133
- Loema Instituto de Pesquisa Clinica
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Fortaleza, Brazil, 60160-230
- Instituto de Estudos e Pesquisas Clinicas do Ceara IEP-CE
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Porto Alegre, Brazil, 90035-001
- Hospital Moinhos de Vento
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Porto Alegre, Brazil, 90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul
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Rio de Janeiro, Brazil, 20241-180
- IBPClin - Instituto Brasil de Pesquisa Clínica
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Santo André, Brazil, 09080-110
- Pesquisare Saude
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São José dos Campos, Brazil, 12243-280
- ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas
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São Paulo, Brazil, 01228-200
- CPCLIN
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São Paulo, Brazil, 01229-010
- NotreDame Intermedica Saude S.A
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São Paulo, Brazil, 04012-909
- Instituto Dante Pazzanese de Cardiology
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São Paulo, Brazil, 01409-902
- Hospital 9 De Julho
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São Paulo, Brazil, 01236030
- BR Trials - Ensaios Clinicos e Consultoria
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Vitória, Brazil, 29055450
- CEDOES
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Brandýs nad Labem, Czechia, 25001
- Diacentrum Brandys n.L. s.r.o.
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Brno-Židenice, Czechia, 615 00
- EFERTUS healthcare s.r.o.
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Broumov, Czechia, 550 01
- EDUMED - Broumov
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Hranice, Czechia, 753 01
- AIDIN VK s.r.o.
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Jaroměř, Czechia, 551 01
- EDUMED - Jaroměř
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Krnov, Czechia, 79401
- MUDr. Tomas Edelsberger
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Náchod, Czechia, 547 01
- EDUMED - Náchod
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Olomouc, Czechia, 779 00
- PreventaMed
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Ostrava, Czechia, 702 00
- Private Practice - Dr. Miroslav Koliba
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Pardubice V, Czechia, 530 02
- Diahelp s.r.o
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Pilsen, Czechia, 301 00
- Dialine - Interni a diabetologicka ambulance
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Prague, Czechia, 150 00
- EUC Klinika Praha
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Prague, Czechia, 14900
- Milan Kvapil s.r.o., Diabetologicka ambulance
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Prague, Czechia, 150 00
- Praglandia s.r.o
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Prague, Czechia, 140 00
- DiaVize s.r.o.
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Prague, Czechia, 140 00
- MEDICON
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Prague, Czechia, 140 00
- MUDr. Michala Pelikanova s.r.o.
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Prague, Czechia, 160 00
- Fledip s.r.o.
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Prague, Czechia, 160 00
- Nefromed
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Praha 9 - Klanovice, Czechia, 190 14
- MUDr. Barbora Diepoltova
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Český Krumlov, Czechia, 381 01
- Nemocnice Cesky krumlov
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Berlin, Germany, 13187
- Diabetespraxis Dr. Braun
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Eisenach, Germany, 99817
- Gemeinschaftspraxis für Diabetologie
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Essen, Germany, 45355
- Praxis am Markt - Dr. Bernd Becker
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Fulda, Germany, 36037
- MVZ im Altstadt-Carree Fulda GmbH
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Hof, Germany, 95030
- Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel
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Leipzig, Germany, 04249
- Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
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Magdeburg, Germany, 39120
- SMO.MD GmbH
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Mühldorf, Germany, 84453
- Gemeinschaftpraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte
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Oldenburg, Germany, 23758
- RED-Institut GmbH
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Pohlheim, Germany, 35415
- Diabetologische Schwerpunktpraxis Marck Linn Pickel
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Rehlingen, Germany, 66780
- Praxis Dr. Veronika Wenzl-Bauer
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Athens, Greece, 11527
- General Hospital of Athens Laiko
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Athens, Greece, 11527
- General Hospital of Athens "G. Gennimatas"
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Chaïdári, Greece, 12462
- Attikon General University Hospital
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Lamia, Greece, 351 00
- General Hospital of Lamia
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Palaió Fáliro, Greece, 17562
- Iatriko Paleou Falirou Medical Center
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Thessaloniki, Greece, 546 35
- G. Gennimatas General Hospital of Thessaloniki
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Ahmedabad, India, 380006
- V.S. General Hospital
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Bangalore, India, 560002
- Victoria Hospital, Bangalore Medical College And Research Institute
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Bangalore, India, 560092
- Life Care Hospital and Research Centre
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Cuttack, India, 753001
- S C B Medical College and Hospital
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Guwahati, India, 781033
- Apollo Excelcare Hospital
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Hubli, India, 580021
- Karnataka Institute of Medical Sciences
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Jaipur, India, 302020
- Eternal Heart Care Center and Research Institute
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Mumbai, India, 400012
- King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
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Nagpur, India, 440015
- Central India Cardiology and Research Institute
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Pune, India, 411021
- Chellaram Diabetes Institute
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Surat, India, 395002
- Nirmal Hospital Pvt Ltd.
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Bergamo, Italy, 24127
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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Catanzaro, Italy, 88100
- AOU Renato Dulbecco
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Chieti, Italy, 66100
- Università degli Studi Gabriele D' Annunzio
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Milan, Italy, 20132
- Ospedale San Raffaele
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Naples, Italy, 80100
- University of Naples Federico II
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Novara, Italy, 28100
- Azienda Ospedaliero Universitaria Maggiore della Carità
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Perugia, Italy, 06132
- AO Santa Maria della Misericordia
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Roma, Italy, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
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Siena, Italy, 53100
- Azienda Ospedaliero Universitaria Senese
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Trieste, Italy, 34125
- Azienda sanitaria universitaria giuliano isontina ASUGI Ospedale Maggiore- Università di Trieste
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Aguascalientes, Mexico, 20230
- Centro de Investigación Cardiometabólica de Aguascalientes
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Aguascalientes, Mexico, 20124
- Clinica San Cosme
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Chihuahua City, Mexico, 31217
- Investigacion En Salud Y Metabolismo Sc
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Ciudad Madero, Mexico, 89440
- Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
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Culiacán, Mexico, 80230
- Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.
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Durango, Mexico, 34000
- Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
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Guadalajara, Mexico, 44130
- Diseno y Planeacion en Investigacion Medica
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Guadalajara, Mexico, 44670
- Private Practice - Dr. Francisco Gerardo Padilla
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León, Mexico, 37520
- Instituto Cardiovascular de León S.C.
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Monterrey, Mexico, 64060
- Cardiolink Clin Trials
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Querétaro, Mexico, 76000
- Centro de Estudios Clínicos de Querétaro (CECLIQ)
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Tijuana, Mexico, 22500
- Centro de Investigacion Cardiovascular y Metabolica
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Caguas, Puerto Rico, 00725
- Centro de Endocrinologia y Nutricion
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Dorado, Puerto Rico, 00646
- Dorado Medical Complex
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Manati, Puerto Rico, 00674
- Manati Center for Clinical Research
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Ponce, Puerto Rico, 00717
- Puerto Rico Medical Research
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Ponce, Puerto Rico, 00717
- Research and Cardiovascular Corp.
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San Juan, Puerto Rico, 00918
- Mindful Medical Research
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San Juan, Puerto Rico, 00917
- GCM Medical Group, PSC - Hato Rey Site
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San Juan, Puerto Rico, 00921
- Mgcendo Llc
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Vega Baja, Puerto Rico, 00694
- Wellness clinical Research Vega Baja
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Bacau, Romania, 600154
- CMI Dr.Pletea Noemi SRL
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Bacau, Romania, 600274
- SC Minimed SRL
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Brasov, Romania, 500097
- Mariodiab Clinic
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Brasov, Romania, 500283
- C.M.D.T.A. Neomed
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Bucharest, Romania, 011053
- Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului
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Bucharest, Romania, 010507
- Nicodiab
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Bucharest, Romania, 010627
- Geea Medical Easy Diet
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Bucharest, Romania, 013764
- Centrul Medical NutriLife
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Bucharest, Romania, 50538
- Centrul Medical Endocrinologie si Diabet Dr. Paveliu
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Galați, Romania, 800291
- Diamed Obesity
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Galați, Romania, 800001
- Milena Sante
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Iași, Romania, 700547
- Centrul Medical Consultmed
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Iași, Romania, 700732
- Cardiomed Iași
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Oradea, Romania, 410147
- Diabdana
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Oradea, Romania, 410159
- Centrul Medical Grandmed
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Ploieşti, Romania, 100169
- Diabmed Dr. Popescu Alexandrina
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Satu Mare, Romania, 440055
- Clinica Korall
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Timișoara, Romania, 300288
- Cabinet Medical Dr.Geru
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Târgu Mureş, Romania, 540142
- Centrul Medical Mediab
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Bratislava, Slovakia, 831 01
- Diacrin s.r.o.
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Bytča, Slovakia, 014 01
- Diab - Int
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Košice, Slovakia, 04001
- Human Care s.r.o.
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Lučenec, Slovakia, 984 01
- IN-DIA
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Malacky, Slovakia, 901 01
- MediVet s.r.o.
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Púchov, Slovakia, 020 01
- DIA-MED CENTRUM s.r.o.
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Rožňava, Slovakia, 04801
- Tatratrial s.r.o.
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Sabinov, Slovakia, 083 01
- MEDI-DIA s.r.o.
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Trebišov, Slovakia, 075 01
- ARETEUS s.r.o.
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Trnava, Slovakia, 917 01
- JAL
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Ľubochňa, Slovakia, 034 91
- NEDÚ - Národný endokrinologický a diabetologický ústav n.o.
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Daejeon, South Korea, 01830
- Eulji University Hospital
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Guri-si, South Korea, 11923
- Hanyang University Guri Hospital
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Gyeongsan-si, South Korea, 42415
- Yeungnam Univeristy Medical Center
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Seongnam, South Korea, 13620
- Seoul National University Bundang Hospital
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Seoul, South Korea, 03080
- Seoul National University Hospital
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Seoul, South Korea, 01830
- Nowon Eulji Medical Center, Eulji University
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Seoul, South Korea, 03181
- Kangbuk Samsung Hospital
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Seoul, South Korea, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, South Korea, 05278
- Kyung Hee University Hospital at Gangdong
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Seoul, South Korea, 06591
- The Catholic Univ. of Korea Seoul St. Mary's Hospital
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Ulsan, South Korea, 44033
- Ulsan University Hospital
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Wŏnju, South Korea, 26426
- WonJu Severance Christian Hospital
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Wŏnju, South Korea, 26426
- Yonsei University-Wonju Severance Christian Hospital
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A Coruña, Spain, 15006
- CHUAC-Complejo Hospitalario Universitario A Coruña
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Alzira, Spain, 46600
- Hospital Universitario de La Ribera
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Córdoba, Spain, 14004
- Hospital Universitario Reina Sofia
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Madrid, Spain, 28006
- Complejo Hospitalario Ruber Juan Bravo
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Oviedo, Spain, 33011
- Hospital Universitario Central de Asturias
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Pozuelo de Alarcón, Spain, 28223
- Hospital Universitario Quirónsalud Madrid
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Santander, Spain, 39008
- Hospital Universitario Marqués de Valdecilla
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Segovia, Spain, 40002
- Hospital General de Segovia
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Seville, Spain, 41013
- Hospital Universitario Virgen del Rocio
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Seville, Spain, 41003
- Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
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Seville, Spain, 41950
- Vithas Hospital Sevilla
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Ankara, Turkey (Türkiye), 06230
- Ankara Universitesi Tip Fakultesi Hastanesi
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Aydin, Turkey (Türkiye), 09100
- Adnan Menderes University Medical Faculty
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Diyarbakır, Turkey (Türkiye), 21100
- Dicle Üniversitesi
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Kayseri, Turkey (Türkiye), 38030
- Erciyes University Medical Faculty
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Malatya, Turkey (Türkiye), 44280
- İnönü Üniversitesi Turgut Özal Tıp Merkezi
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Mersin, Turkey (Türkiye), 33343
- Mersin University
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Pamukkale, Turkey (Türkiye), 20070
- Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre
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Yüreğir, Turkey (Türkiye), 01250
- Baskent University Dr. Turgut Noyan Research and Training Center
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Alabama
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Daphne, Alabama, United States, 36526
- Alliance for Multispecialty Research, LLC
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Mobile, Alabama, United States, 36608
- Alliance for Multispecialty Research, LLC
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Pelham, Alabama, United States, 35124
- Cahaba Research - Pelham
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Sheffield, Alabama, United States, 35660
- Syed Research Consultants LLC
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Arizona
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Chandler, Arizona, United States, 85224
- The Institute for Liver Health
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Mesa, Arizona, United States, 85206
- Aventiv Research
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Peoria, Arizona, United States, 85381
- Arizona Liver Health - Peoria
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Phoenix, Arizona, United States, 85018
- Elite Clinical Studies, LLC
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Phoenix, Arizona, United States, 85051
- Absolute Clinical Research
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Sun City West, Arizona, United States, 85375
- Clinical Research Institute of Arizona (CRI) - Sun City West
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Tempe, Arizona, United States, 85281
- Alliance for Multispecialty Research, LLC
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Tucson, Arizona, United States, 85741
- Orange Grove Family Practice
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Arkansas
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Little Rock, Arkansas, United States, 72205
- KLR Business Group, Inc. dba Arkansas Clinical Research
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California
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Canoga Park, California, United States, 91303
- Hope Clinical Research, Inc.
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Covina, California, United States, 91723
- Valley Clinical Trials, Inc.
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Escondido, California, United States, 92025
- Neighborhood Healthcare Institute of Health
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Fresno, California, United States, 93720
- Valley Research
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Lake Forest, California, United States, 92630
- Orange County Research Center
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Long Beach, California, United States, 90815
- Ark Clinical Research
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Los Alamitos, California, United States, 90720
- Pacific Clinical Studies
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Los Angeles, California, United States, 90017
- Velocity Clinical Research, Los Angeles
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Norco, California, United States, 92860
- Infinity Clinical Research - Norco
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North Hollywood, California, United States, 91606
- Velocity Clinical Research, North Hollywood
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Northridge, California, United States, 91325
- Valley Clinical Trials, Inc.
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Rancho Cucamonga, California, United States, 91730
- Rancho Cucamonga Clinical Research
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San Carlos, California, United States, 94070
- LCGK Research
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San Ramon, California, United States, 94583
- Norcal Endocrinology & Internal Medicine
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Santa Ana, California, United States, 92704
- Velocity Clinical Research, Coastal Heart Medical Group
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Walnut Creek, California, United States, 94598
- Diablo Clinical Research, Inc.
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Westlake Village, California, United States, 91361
- Millennium Clinical Trials
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Anschutz Medical Campus
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Aurora, Colorado, United States, 80045
- Rocky Mountain Regional VA Medical Center
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Colorado Springs, Colorado, United States, 80909
- Legacy Clinical Trials
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Connecticut
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Hamden, Connecticut, United States, 06517
- CMR of Greater New Haven, LLC
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Florida
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Altamonte Springs, Florida, United States, 32714
- Orlando Heart & Vascular Institute
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Atlantis, Florida, United States, 33462
- JEM Research Institute
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Boca Raton, Florida, United States, 33434
- Excel Medical Clinical Trials
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Edgewater, Florida, United States, 32132
- Velocity Clinical Research, New Smyrna Beach
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Fort Myers, Florida, United States, 33912
- Alliance for Multispecialty Research, LLC
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Hialeah, Florida, United States, 33012
- Indago Research & Health Center, Inc
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Inverness, Florida, United States, 34452
- Nature Coast Clinical Research - Inverness
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Jacksonville, Florida, United States, 32204
- Northeast Research Institute - Downtown Office
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Lakeland, Florida, United States, 33805
- Clinical Research of Central Florida
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Leesburg, Florida, United States, 34748
- Clinical Site Partners Leesburg
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Miami, Florida, United States, 33144
- L&C Professional Medical Research Institute
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Miami Lakes, Florida, United States, 33014
- Panax Clinical Research
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Mt. Dora, Florida, United States, 32757
- Adult Medicine of Lake County
-
Ocala, Florida, United States, 34470
- Renstar Medical Research
-
Ocoee, Florida, United States, 34761
- West Orange Endocrinology
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Tampa, Florida, United States, 33614
- Precision Research Center
-
Tampa, Florida, United States, 33625
- Care Access - Tampa
-
Tampa, Florida, United States, 33607
- Better Life Clinical Research
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West Palm Beach, Florida, United States, 33401
- Metabolic Research Institute, Inc.
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Weston, Florida, United States, 33331
- Encore Medical Research - Weston
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Winter Park, Florida, United States, 32789
- Conquest Research
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Georgia
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Lawrenceville, Georgia, United States, 30046
- Balanced Life Health Care Solutions/SKYCRNG
-
Macon, Georgia, United States, 31210
- The Jones Center Clinical Research
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Stockbridge, Georgia, United States, 30281
- Clinical Research Atlanta
-
Union City, Georgia, United States, 30291
- Rophe Adult and Pediatric Medicine/SKYCRNG
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Woodstock, Georgia, United States, 30189
- North Georgia Clinical Research
-
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Idaho
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Blackfoot, Idaho, United States, 83221
- Elite Clinical Trials
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Nampa, Idaho, United States, 83686
- Saltzer Health
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Rexburg, Idaho, United States, 83440
- Elite Clinical Trials
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Illinois
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Chicago, Illinois, United States, 60640
- Great Lakes Clinical Trials - Ravenswood
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Crystal Lake, Illinois, United States, 60012
- Midwest CRC
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Oak Brook, Illinois, United States, 60523
- AMR Clinical
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Skokie, Illinois, United States, 60077
- Northshore University Health System
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Indiana
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Avon, Indiana, United States, 46123
- American Health Network of Indiana, LLC - Avon
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Brownsburg, Indiana, United States, 46112
- Investigators Research Group
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Evansville, Indiana, United States, 47715
- Qualmedica Research, LLC
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Franklin, Indiana, United States, 46131
- American Health Network of Indiana, LLC - Franklin
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Greenfield, Indiana, United States, 46140
- American Health Network of Indiana, LLC - Greenfield
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Muncie, Indiana, United States, 47304
- American Health Network of Indiana, LLC - Muncie
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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West Des Moines, Iowa, United States, 50265
- Iowa Diabetes and Endocrinology Research Center
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Kansas
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Newton, Kansas, United States, 67114
- Alliance for Multispecialty Research, LLC
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Topeka, Kansas, United States, 66606
- Cotton O'Neil Mulvane
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Topeka, Kansas, United States, 66606
- Cotton O'Neil Diabetes & Endocrinology
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Kentucky
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Bowling Green, Kentucky, United States, 42101
- Qualmedica Research
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Louisville, Kentucky, United States, 40213
- L-MARC Research Center
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Louisiana
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Covington, Louisiana, United States, 70433
- Louisiana Heart Center - Convington
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Lake Charles, Louisiana, United States, 70601
- Care Access - Lake Charles (Bayou Pines)
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New Orleans, Louisiana, United States, 70119
- Alliance for Multispecialty Research, LLC
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Maryland
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Baltimore, Maryland, United States, 21229
- Maryland Cardiovascular Specialists
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Rockville, Maryland, United States, 20852
- Endocrine and Metabolic Consultants
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Massachusetts
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Methuen, Massachusetts, United States, 01844
- ActivMed Practices and Research
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Michigan
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Dearborn, Michigan, United States, 48126
- Revival Research Institute
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Troy, Michigan, United States, 48098
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
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Mississippi
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Fayette, Mississippi, United States, 39069
- SKY Clinical Research Network Group - Hall
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Ridgeland, Mississippi, United States, 39157
- SKY Integrative Medical Center/SKYCRNG
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Missouri
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Chesterfield, Missouri, United States, 63005
- Clinical Research Professionals
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Chesterfield, Missouri, United States, 63017
- Diabetes and Endocrinology Specialists
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City of Saint Peters, Missouri, United States, 63303
- StudyMetrix Research
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Springfield, Missouri, United States, 65807
- Clinvest Research LLC
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Montana
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Kalispell, Montana, United States, 59901
- Logan Health Research
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Missoula, Montana, United States, 59808
- Montana Medical Research
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Nevada
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Las Vegas, Nevada, United States, 89106
- Sierra Clinical Research
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Las Vegas, Nevada, United States, 89148
- Palm Research Center Sunset
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Las Vegas, Nevada, United States, 89128
- Palm Research Center Tenaya
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Las Vegas, Nevada, United States, 89128
- Las Vegas Medical Research
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Reno, Nevada, United States, 89511
- Northern Nevada Endocrinology
-
Reno, Nevada, United States, 89521
- Renown South Meadows Medical Center
-
-
New Jersey
-
East Brunswick, New Jersey, United States, 08816
- UniMed Center
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87109
- Ima Clinical Research
-
-
New York
-
Albany, New York, United States, 12208
- Albany Stratton VA Medical Center
-
Binghamton, New York, United States, 13905
- Meridian Clinical Research, LLC
-
Brooklyn, New York, United States, 11203
- SUNY Downstate Health Sciences University
-
East Syracuse, New York, United States, 13057
- Velocity Clinical Research, Syracuse
-
Hartsdale, New York, United States, 10530
- IMA Clinical Research Westchester
-
Long Island City, New York, United States, 11106
- NYC Research INC
-
New Windsor, New York, United States, 12553
- Mid Hudson Medical Research
-
New York, New York, United States, 10036
- Ima Clinical Research Manhattan
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- University of North Carolina Medical Center
-
Fayetteville, North Carolina, United States, 28314
- Care Access - Fayetteville
-
Greensboro, North Carolina, United States, 27408
- PharmQuest Life Sciences, LLC
-
Morehead City, North Carolina, United States, 28557
- Lucas Research, Inc
-
Shelby, North Carolina, United States, 28150
- Carolina Research Center
-
Statesville, North Carolina, United States, 28625
- Accellacare - Piedmont
-
Wilmington, North Carolina, United States, 28401
- Accellacare - Wilmington - 1917 Tradd Court
-
-
North Dakota
-
Fargo, North Dakota, United States, 58104
- Lillestol Research
-
-
Ohio
-
Columbus, Ohio, United States, 43215
- Remington-Davis, Inc
-
Columbus, Ohio, United States, 43213
- Centricity Research Columbus Ohio Multispecialty
-
-
Oklahoma
-
Moore, Oklahoma, United States, 73160
- Tekton Research, Inc
-
Tulsa, Oklahoma, United States, 74136
- Central States Research
-
-
Oregon
-
Portland, Oregon, United States, 97202
- Northwest Research Center
-
-
Pennsylvania
-
Beaver, Pennsylvania, United States, 15009
- Heritage Valley Medical Group, Inc.
-
Newport, Pennsylvania, United States, 17074
- Capital Area Research - Newport
-
Philadelphia, Pennsylvania, United States, 19114
- Clinical Research of Philadelphia
-
Pittsburgh, Pennsylvania, United States, 15243
- Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
-
Uniontown, Pennsylvania, United States, 15401
- Preferred Primary Care Physicians
-
-
South Carolina
-
Greenville, South Carolina, United States, 29607
- The Research Center of The Upstate
-
Mauldin, South Carolina, United States, 29662
- Care Access - Mauldin
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37909
- New Phase Research and Development
-
Knoxville, Tennessee, United States, 37909
- Alliance for Multispecialty Research, LLC
-
Tullahoma, Tennessee, United States, 37388
- Tennessee Center for Clinical Trials
-
-
Texas
-
Austin, Texas, United States, 78749
- Texas Diabetes & Endocrinology, P.A.
-
Corpus Christi, Texas, United States, 78404
- South Texas Clinical Research
-
Dallas, Texas, United States, 75230
- Velocity Clinical Research, Dallas
-
Dallas, Texas, United States, 75208
- Thyroid, Endocrinology, and Diabetes
-
Denison, Texas, United States, 75020
- Soma Clinical Trials
-
Denison, Texas, United States, 75020
- Cardio Voyage
-
Forney, Texas, United States, 75126
- Care United Research
-
Fort Worth, Texas, United States, 76132
- Diabetes and Thyroid Center of Ft. Worth
-
Fort Worth, Texas, United States, 76164
- Valley Institute of Research - Fort Worth
-
Houston, Texas, United States, 77040
- Juno Research
-
Houston, Texas, United States, 77043
- Biopharma Informatic, LLC
-
Houston, Texas, United States, 77079
- Endocrine Ips, Pllc
-
Houston, Texas, United States, 77024
- Victorium Clinical Research - Houston
-
Houston, Texas, United States, 77089
- Research Physicians Network, LLC
-
McAllen, Texas, United States, 78503
- Biopharma Informatic, LLC
-
Mesquite, Texas, United States, 75149
- Southern Endocrinology Associates
-
Round Rock, Texas, United States, 78681
- Texas Diabetes & Endocrinology, P.A.
-
San Antonio, Texas, United States, 78229
- Clinical Trials of Texas, LLC
-
San Antonio, Texas, United States, 78229
- Audie L Murphy VA Hospital
-
San Antonio, Texas, United States, 78230
- VIP Trials
-
Shavano Park, Texas, United States, 78231
- Consano Clinical Research, LLC
-
Sherman, Texas, United States, 75090
- Sherman Clinical Research
-
Tomball, Texas, United States, 77375
- Northwest Houston Heart Center
-
Weslaco, Texas, United States, 78596
- Texas Valley Clinical Research
-
Wylie, Texas, United States, 75098
- Soma Clinical Trials
-
-
Utah
-
Salt Lake City, Utah, United States, 84107
- Wasatch Clinical Research, LLC
-
St. George, Utah, United States, 84790
- Chrysalis Clinical Research
-
West Jordan, Utah, United States, 84088
- Velocity Clinical Research, Salt Lake City
-
West Valley City, Utah, United States, 84120
- Kalo Clinical Research
-
-
Virginia
-
Manassas, Virginia, United States, 20110
- Manassas Clinical Research Center
-
Midlothian, Virginia, United States, 23114
- Virginia Research Center
-
Norfolk, Virginia, United States, 23510
- Eastern Virginia Medical School (EVMS) Strelitz Diabetes Research Center
-
Suffolk, Virginia, United States, 23435
- Centricity Research Suffolk Family Medicine
-
-
Washington
-
Redmond, Washington, United States, 98052
- Eastside Research Associates
-
Spokane, Washington, United States, 99202
- MultiCare Rockwood Clinic- Main
-
Tacoma, Washington, United States, 98405
- Universal Research Group
-
-
Wisconsin
-
Green Bay, Wisconsin, United States, 54303
- St. Vincent Hospital d/b/a Prevea Health
-
Kenosha, Wisconsin, United States, 53144
- Clinical Investigation Specialists
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Have been diagnosed with type 2 diabetes mellitus (T2DM)
- Are at least 18 years of age or legal age of consent in the jurisdiction in which the study is taking place, whichever is older.
Have HbA1c at screening
- ≥7.0% and ≤10.5% if background diabetes medication does not include a sulfonylurea, or
- ≥7.5% and ≤10.5% if background diabetes medication includes a sulfonylurea.
- Are on stable treatment of at least 1 and no more than 3 oral antihyperglycemic drugs for at least 90 days before screening. Antihyperglycemic drugs may include metformin, SGLT-2 inhibitors, and/or sulfonylureas
Have increased risk for cardiovascular (CV) events due to:
- Coronary heart disease
- Peripheral arterial disease, presumed to be of atherosclerotic origin
- Cerebrovascular disease, presumed to be of atherosclerotic origin
- Chronic kidney disease (CKD)
- Congestive heart failure (CHF) New York Heart Association (NYHA) functional classification II to III
- Are of stable weight (± 5%) for at least 90 days prior to screening
- Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening
Exclusion Criteria:
- Have type 1 diabetes mellitus
- Have had chronic or acute pancreatitis any time prior to screening
- Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (e.g. laster photocoagulation or intravitreal injections of anty-VEGF inhibitors
- Have a known clinically significant gastric emptying abnormality
- Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) or aspartate aminotransferase (AST) enzyme level ≥5.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory
- Have had any of the following within 60 days prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization for congestive heart failure
- Have an eGFR <15 mL/min/1.73 m2 as determined at screening
- Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors, and/or sulfonylureas during the last 90 days
- Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Orforglipron
Participants will receive escalated doses of orforglipron orally.
|
Administered orally once daily
Other Names:
|
|
Active Comparator: Insulin Glargine
Participants will receive insulin glargine subcutaneously (SC).
Doses will be individualized and titrated according to a treat-to-target algorithm.
|
Administered SC once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death]
Time Frame: Baseline to End of the Study (Approximate Maximum 104 Weeks)
|
Time to First Occurrence of Any MACE-4 (Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular [CV] Death)
|
Baseline to End of the Study (Approximate Maximum 104 Weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Body Weight
Time Frame: Baseline, Week 52
|
Change from Baseline in Body Weight
|
Baseline, Week 52
|
|
Change from Baseline in Fasting Serum Glucose
Time Frame: Baseline, Week 52
|
Change from Baseline in Fasting Serum Glucose
|
Baseline, Week 52
|
|
Time to First Occurrence of Any MACE-3 Event (MI, Stroke, or CV death)
Time Frame: Baseline to End of the Study (Approximately 104 Weeks)
|
Time to First Occurrence of Any MACE-3 Event (MI, Stroke, or CV death)
|
Baseline to End of the Study (Approximately 104 Weeks)
|
|
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 52
|
Change from Baseline in HbA1c
|
Baseline, Week 52
|
|
Change from Baseline in Daily Average 7-point Self-monitoring Blood Glucose (SMBG) Profile
Time Frame: Baseline, Week 52
|
Change from Baseline in Daily Average 7-point SMBG
|
Baseline, Week 52
|
|
Percentage of Participants with HbA1c Target Values Less Than (<)7.0% (53 mmol/mol)
Time Frame: Week 52
|
Percentage of Participants with HbA1c Target Values <7.0% (53 mmol/mol)
|
Week 52
|
|
Percent Change from Baseline Body Weight
Time Frame: Week 52
|
Percent Change from Baseline Body Weight
|
Week 52
|
|
Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Score
Time Frame: Baseline, Week 52
|
The SF-36v2 acute form is a 36-item generic, participant completed measure designed to assess 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.
Scores of each domain are measured by T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health.
|
Baseline, Week 52
|
|
Pharmacokinetics (PK): Plasma Serum Concentrations of Orforglipron
Time Frame: Baseline through Week 52
|
PK will be estimated based on the population PK model.
|
Baseline through Week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2023
Primary Completion (Actual)
March 16, 2026
Study Completion (Actual)
March 16, 2026
Study Registration Dates
First Submitted
March 27, 2023
First Submitted That Met QC Criteria
March 27, 2023
First Posted (Actual)
April 7, 2023
Study Record Updates
Last Update Posted (Actual)
April 17, 2026
Last Update Submitted That Met QC Criteria
April 16, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Endocrine System Diseases
- Pathologic Processes
- Nutrition Disorders
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Metabolic Diseases
- Overnutrition
- Body Weight
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Overweight
- Obesity
- Diabetes Mellitus, Type 2
- Cardiovascular Diseases
- Renal Insufficiency, Chronic
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Peptide Hormones
- Peptides
- Amino Acids, Peptides, and Proteins
- Insulin, Long-Acting
- Insulins
- Pancreatic Hormones
- Insulin Glargine
- orforglipron
Other Study ID Numbers
- 18563
- J2A-MC-GZGS (Other Identifier: Eli Lilly and Company)
- 2022-502833-25-00 (Other Identifier: EU Trial Number)
- U1111-1285-6821 (Other Identifier: Universal Trial Number (UTN))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later.
Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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