A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin (ACHIEVE-3)

April 17, 2024 updated by: Eli Lilly and Company

A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Oral Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-3)

The main purpose of this study is to assess efficacy and safety of orforglipron compared with oral semaglutide in participants with Type 2 diabetes and inadequate glycemic control with metformin.The study will last around 61 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1576

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 Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@Lilly.com

Study Locations

  • Argentina
      • Córdoba, Argentina, 5000
        • Recruiting
        • Instituto de Investigaciones Clínicas Córdoba
        • Principal Investigator:
          • Ines Palmira Bartolacci
      • Córdoba, Argentina, 5003DCE
        • Recruiting
        • Instituto Médico DAMIC
        • Principal Investigator:
          • Adriana Alicia Villarino
      • Santiago del Estero, Argentina, 4200
        • Recruiting
        • Sanatorio Norte
        • Principal Investigator:
          • Franklin Hector Abalos
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1056
        • Recruiting
        • Centro de Investigaciones Metabólicas (CINME)
        • Principal Investigator:
          • Federico C. Perez Manghi
      • Lanus, Buenos Aires, Argentina, B1824KAJ
        • Recruiting
        • CIMeL Clinical Research
        • Principal Investigator:
          • Mariano Ignacio Chahin
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Recruiting
        • Centro de Investigaciones Medicas Mar del Plata
        • Principal Investigator:
          • Adrian Eduardo Hernandez Gauna
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Recruiting
        • Policlinica Red OMIP
        • Principal Investigator:
          • Claudia Goycoa
    • Ciudad Aut
      • Buenos Aires, Ciudad Aut, Argentina, C1120AAC
        • Recruiting
        • Centro Médico Viamonte
        • Contact:
          • Phone Number: 541149635650
        • Principal Investigator:
          • Diego Aizenberg
    • Ciudad Autónoma De Buenos Aires
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1061AAS
        • Recruiting
        • CIPREC
        • Principal Investigator:
          • Fernando Guerlloy
      • Caba, Ciudad Autónoma De Buenos Aires, Argentina, 1204
        • Recruiting
        • Instituto Centenario
        • Principal Investigator:
          • SUSANA SALZBERG
      • Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, 1405
        • Recruiting
        • Consultorio de Investigación Clínica EMO SRL
        • Principal Investigator:
          • Pablo Rene Costanzo
    • La Pampa
      • Santa Rosa, La Pampa, Argentina, 6300
        • Recruiting
        • Centro de Salud e Investigaciones Médicas
        • Principal Investigator:
          • Marcos Alejandro Mayer
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Recruiting
        • Instituto Médico Catamarca IMEC
        • Principal Investigator:
          • Natacha Natacha Maldonado
      • Rosario, Santa Fe, Argentina, 2000
        • Recruiting
        • Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
        • Principal Investigator:
          • Horacio Angel Sessa
      • Rosario, Santa Fe, Argentina, S2000DEJ
        • Recruiting
        • Fundacion Estudios Clinicos
        • Principal Investigator:
          • María Mercedes Schiavoni
      • Rosario, Santa Fe, Argentina, 2000
        • Recruiting
        • Instituto de Especialidades de La Salud Rosario
        • Principal Investigator:
          • Ana Elisa Chiesa
      • Rosario, Santa Fe, Argentina, 2000
        • Recruiting
        • Instituto de Investigaciones Clínicas Zárate
        • Principal Investigator:
          • Marisa Liliana Vico
  • China
    • Beijing
      • Beijing, Beijing, China, 101200
        • Recruiting
        • Beijing Pinggu District Hospital
        • Contact:
          • Phone Number: 13911080328
        • Principal Investigator:
          • yufeng li
    • Chongqing
      • Chongqing, Chongqing, China, 400014
        • Recruiting
        • Chongqing General Hospital
        • Contact:
          • Phone Number: 8613983685857
        • Principal Investigator:
          • Hongman Wang
    • Guangdong
      • Foshan, Guangdong, China, 528399
        • Recruiting
        • Shunde Hospital of Southern Medical Univesity
        • Principal Investigator:
          • Jie Shen
      • Huizhou, Guangdong, China, 516001
        • Recruiting
        • Huizhou Municipal Central Hospital
        • Principal Investigator:
          • Shu Li
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • The Fourth Hospital of Harbin Medical University
        • Principal Investigator:
          • ZhiFeng Cheng
    • Henan
      • Luoyang Shi, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science &Technology
        • Principal Investigator:
          • Hongwei Jiang
        • Contact:
          • Phone Number: 13653880139
      • Nanyang, Henan, China, 473014
        • Recruiting
        • Nanyang First People's Hospital
        • Principal Investigator:
          • Yihua Wang
      • Zhengzhou, Henan, China, 450014
        • Recruiting
        • The Second Affiliated Hospital of Zhengzhou University
        • Contact:
          • Phone Number: 15838123695
        • Principal Investigator:
          • Qingju Li
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • Recruiting
        • The Second Affiliated Hospital of Nanjing Medical University
        • Principal Investigator:
          • Yibing Lu
        • Contact:
          • Phone Number: 18951762690
      • Nanjing, Jiangsu, China, 210006
        • Recruiting
        • Nanjing First Hospital
        • Principal Investigator:
          • Jianhua Ma
      • Zhenjiang, Jiangsu, China, 212000
        • Recruiting
        • Affiliated Hospital of Jiangsu University
        • Principal Investigator:
          • Guoyue Yuan
    • Jiangxi
      • Pingxiang, Jiangxi, China, 337055
        • Recruiting
        • Jiangxi Pingxiang People's Hospital
        • Principal Investigator:
          • Yawei Zhang
    • Liaoning
      • Dalian, Liaoning, China, 116033
        • Recruiting
        • Dalian Municipal Central Hospital Affiliated Of Dalian Medical University
        • Contact:
          • Phone Number: 041184412001
        • Principal Investigator:
          • Xinyu Li
    • Shandong
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Jinan Central Hospital
        • Contact:
          • Phone Number: 15318816218
        • Principal Investigator:
          • Xiaolin Dong
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Sixth People's Hospital
        • Principal Investigator:
          • Jian Zhou
      • Shanghai, Shanghai, China, 201200
        • Recruiting
        • Pudong New Area People's Hospital Shanghai
        • Principal Investigator:
          • Xiaozhen JIANG
    • Sichuan
      • ChengDu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Phone Number: 18980601658
        • Principal Investigator:
          • zhenmei an
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University
        • Principal Investigator:
          • Yushan Xu
        • Contact:
          • Phone Number: 13888610416
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310013
        • Recruiting
        • Zhejiang Hospital
        • Principal Investigator:
          • Tian Feng Wu
      • Huzhou, Zhejiang, China, 313000
        • Active, not recruiting
        • Huzhou Central Hospital
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Phone Number: 13758712421
        • Principal Investigator:
          • Hong Zhu
  • Japan
      • Gifu, Japan, 501-1112
        • Recruiting
        • Gifu University Hospital
        • Principal Investigator:
          • Takehiro Kato
    • Ehime
      • Matsuyama, Ehime, Japan, 116099
        • Recruiting
        • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
        • Principal Investigator:
          • Tetsuji Niiya
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0062
        • Recruiting
        • Manda Memorial Hospital
        • Principal Investigator:
          • Hidenori Bando
        • Contact:
          • Phone Number: 81112314032
    • Ibaraki
      • Mito, Ibaraki, Japan, 310-0826
        • Recruiting
        • Nakamoto Internal Medicine Clinic
        • Principal Investigator:
          • shinya nakamoto
      • Naka, Ibaraki, Japan, 311-0113
        • Recruiting
        • Nakakinen clinic
        • Principal Investigator:
          • Takeshi Osonoi
        • Contact:
          • Phone Number: 81293532800
      • Tsuchiura, Ibaraki, Japan, 300-0835
        • Recruiting
        • Ohishi Internal Medicine Clinic
        • Contact:
          • Phone Number: 81298350014
        • Principal Investigator:
          • Akira Ohishi
    • Kanagawa
      • Kamakura-shi, Kanagawa, Japan, 247-0056
        • Recruiting
        • Takai Internal Medicine Clinic
        • Principal Investigator:
          • Masahiko Takai
    • Osaka
      • Kashiwara, Osaka, Japan, 582-0005
        • Recruiting
        • Shiraiwa Medical Clinic
        • Principal Investigator:
          • Toshihiko Shiraiwa
    • Tokyo
      • Ootaku, Tokyo, Japan, 143-0015
        • Recruiting
        • Medical Corporation Sato Medical clinic
        • Principal Investigator:
          • Nobuyuki Sato
  • Mexico
      • Durango, Mexico, 34000
        • Recruiting
        • Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
        • Contact:
          • Phone Number: 6181894111
        • Principal Investigator:
          • José Roberto Lazcano Soto
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 11650
        • Recruiting
        • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
        • Contact:
          • Phone Number: 525585340943
        • Principal Investigator:
          • Melchor Alpizar Salazar
      • Mexico City, Distrito Federal, Mexico, 06760
        • Recruiting
        • CAIMED México
        • Contact:
          • Phone Number: 5565834651
        • Principal Investigator:
          • Laura Castro Castrezana
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Recruiting
        • Private Practice - Dr. Arechavaleta Granell Maria del Rosario
        • Principal Investigator:
          • Maria Del Rosario Arechavaleta Granell
        • Contact:
          • Phone Number: 5233361654104
      • Guadalajara, Jalisco, Mexico, 44670
        • Recruiting
        • Virgen Cardiovascular Research SC
        • Principal Investigator:
          • Luis Ramon Virgen Carrillo
        • Contact:
          • Phone Number: 3338131040
      • Guadalajara, Jalisco, Mexico, 04460
        • Recruiting
        • Instituto Jalisciense de Investigacion en Diabetes y Obesidad
        • Contact:
          • Phone Number: 523336153477
        • Principal Investigator:
          • Guillermo G. Gonzalez Galvez
      • Guadalajara, Jalisco, Mexico, 44670
        • Recruiting
        • CICEJ Centro de Investigación Clínica Endocrinológica de Jalisco S.C
        • Contact:
          • Phone Number: 3312049097
        • Principal Investigator:
          • Silvia Alejandrina Jimenez Ramos
      • Guadalajara, Jalisco, Mexico, 44210
        • Not yet recruiting
        • Consultorio Médico
        • Contact:
          • Phone Number: 523315237659
        • Principal Investigator:
          • Armando Rafael Vargas
      • Zapopan, Jalisco, Mexico, 44260
        • Recruiting
        • Centro de Investigacion Medica de Occidente, S.C.
        • Contact:
          • Phone Number: 523312044280
        • Principal Investigator:
          • Emilia Susana Pelayo Orozco
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64060
        • Recruiting
        • Cardiolink Clin Trials
        • Contact:
          • Phone Number: 8140401554
        • Principal Investigator:
          • Elías García
      • Monterrey, Nuevo León, Mexico, 64460
        • Recruiting
        • Unidad biomedica avanzada monterrey
        • Contact:
          • Phone Number: 8113578896
        • Principal Investigator:
          • Raymundo Garcia Reza
      • Monterrey, Nuevo León, Mexico, 64718
        • Recruiting
        • Eukarya PharmaSite
        • Principal Investigator:
          • Arnulfo Gonzalez
      • Monterrey, Nuevo León, Mexico, 64610
        • Recruiting
        • Clínica García Flores SC
        • Contact:
          • Phone Number: 528183482015
        • Principal Investigator:
          • Pedro Alberto Garcia
      • Monterrey, Nuevo León, Mexico, 66465
        • Recruiting
        • Centro de investigación y control metabólico
        • Contact:
          • Phone Number: 52818348897
        • Principal Investigator:
          • Ramiro Guadalupe Banda Elizondo
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80230
        • Recruiting
        • Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
        • Contact:
          • Phone Number: 6677215355
        • Principal Investigator:
          • Manuel Odin de los Rios Ibarra
  • Puerto Rico
      • Guaynabo, Puerto Rico, 00970
        • Recruiting
        • Private Practice - Dr. Paola Mansilla-Letelier
        • Contact:
          • Phone Number: 7874045252
        • Principal Investigator:
          • Paola Mansilla-Letelier
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • Latin Clinical Trial Center
        • Principal Investigator:
          • Alex Gonzalez-Bossolo
        • Contact:
          • Phone Number: 7879859911
      • San Juan, Puerto Rico, 00921
        • Recruiting
        • Endocrinologist Metabolic Clinic & Research Institute
        • Contact:
          • Phone Number: 7874842757
        • Principal Investigator:
          • Martha Gomez-Cuellar
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85051
        • Recruiting
        • Absolute Clinical Research
        • Principal Investigator:
          • James L Beach
        • Contact:
          • James L Beach
        • Contact:
          • Phone Number: 623-377-7022
    • California
      • Canoga Park, California, United States, 91304
        • Recruiting
        • San Fernando Valley Health Institute
        • Principal Investigator:
          • Jeffrey London
        • Contact:
          • Phone Number: 818-222-6868
      • Escondido, California, United States, 92025
        • Recruiting
        • Neighborhood Healthcare Institute of Health
        • Contact:
          • Phone Number: 760-737-6984
        • Principal Investigator:
          • James H Schultz
      • Gardena, California, United States, 90247
        • Recruiting
        • Velocity Clinical Research, Gardena
        • Principal Investigator:
          • Mark T. Leibowitz
        • Contact:
          • Phone Number: 424-551-7316
      • Los Angeles, California, United States, 90035
        • Recruiting
        • Biopharma Informatic
        • Contact:
          • Phone Number: 281-944-3610
        • Principal Investigator:
          • Samuel Harrison Ross, MD
      • Los Angeles, California, United States, 90057
        • Recruiting
        • National Research Institute - Wilshire
        • Principal Investigator:
          • David Guzman
        • Contact:
          • Phone Number: 213-483-1800
      • Norco, California, United States, 92860
        • Recruiting
        • Infinity Clinical Research - Norco
        • Principal Investigator:
          • Peter Mattar
      • San Ramon, California, United States, 94583
        • Recruiting
        • Norcal Endocrinology & Internal Medicine
        • Principal Investigator:
          • Yshay Shlesinger
        • Contact:
          • Phone Number: 925-552-5280
      • Spring Valley, California, United States, 91978
        • Recruiting
        • Encompass Clinical Research
        • Contact:
          • Phone Number: 619-660-9068
        • Principal Investigator:
          • Hanid Audish
      • Tustin, California, United States, 92780
        • Recruiting
        • University Clinical Investigators, Inc.
        • Principal Investigator:
          • John Kim
    • Colorado
      • Golden, Colorado, United States, 80401
        • Recruiting
        • New West Physicians Clinical Research
        • Principal Investigator:
          • Nicole Pant
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Recruiting
        • Connecticut Clinical Research - Cromwell
        • Contact:
          • Phone Number: 8606320144
        • Principal Investigator:
          • Charles Brendan Montano
    • Florida
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Clinical Research of West Florida, Inc. (Clearwater)
        • Contact:
          • Phone Number: 7274660078
        • Principal Investigator:
          • Leonard Jay Dunn
      • Margate, Florida, United States, 33063
        • Recruiting
        • South Florida Clinical Research Institute
        • Contact:
          • Phone Number: 954-582-7007
        • Principal Investigator:
          • Juan Loy
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Dade Medical Research Institute, LLC
        • Principal Investigator:
          • Orlando Puente
        • Contact:
          • Phone Number: 305-722-7210
      • Ocoee, Florida, United States, 34761
        • Recruiting
        • West Orange Endocrinology
        • Contact:
          • Phone Number: 4074804830
        • Principal Investigator:
          • Jose Manuel Mandry
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • Latin Clinical Trial Center Florida
        • Principal Investigator:
          • Reynaldo Lopez
        • Contact:
          • Phone Number: 787-249-4763
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Clinical Research of West Florida
        • Contact:
          • Phone Number: 813-870-1292
        • Principal Investigator:
          • Lon D. Lynn, DO
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Metabolic Research Institute, Inc.
        • Contact:
          • Phone Number: 5618023060
        • Principal Investigator:
          • Barry Scot Horowitz, MD
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Recruiting
        • Balanced Life Health Care Solutions/SKYCRNG
        • Principal Investigator:
          • Tonita Washington, DNP
      • Stockbridge, Georgia, United States, 30281
        • Recruiting
        • Clinical Research Atlanta
        • Principal Investigator:
          • Deon Miller
    • Idaho
      • Boise, Idaho, United States, 83704
        • Recruiting
        • Northwest Clinical Trials
        • Contact:
          • Phone Number: 2086850600
        • Principal Investigator:
          • Brock Aaron McConnehey
      • Idaho Falls, Idaho, United States, 83404
        • Recruiting
        • Family First Medical Center
        • Contact:
          • Phone Number: 2085527700
        • Principal Investigator:
          • Flint Rudd Packer
    • Indiana
      • Greenfield, Indiana, United States, 46140
        • Recruiting
        • American Health Network of IN, LLC
        • Principal Investigator:
          • Talessa Powell
      • Valparaiso, Indiana, United States, 46383
        • Recruiting
        • Velocity Clinical Research, Valparaiso
        • Contact:
          • Phone Number: 219-464-8302
        • Principal Investigator:
          • Robert J. Buynak
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • Cotton O'Neil Clinical Research Center
        • Principal Investigator:
          • susan brian
      • Wichita, Kansas, United States, 67218
        • Recruiting
        • Tekton Research - Wichita
        • Principal Investigator:
          • Brandon Alleman
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • Delricht Research
        • Principal Investigator:
          • Patrick Dennis
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Joslin Diabetes Center
        • Principal Investigator:
          • Osama Hamdy
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Recruiting
        • Revival Research Institute - Dearborn
        • Principal Investigator:
          • Abdulhassan Saad
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • Recruiting
        • SKY Integrative Medical Center/SKYCRNG
        • Principal Investigator:
          • Bob Hutchins
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Recruiting
        • Kansas City Research Institute
        • Principal Investigator:
          • Bradley Freilich
        • Contact:
          • Phone Number: 816-759-5274
    • Montana
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Glacier View Research Institute - Endocrinology
        • Principal Investigator:
          • Alison Schneider
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Wr-Crcn, Llc
        • Principal Investigator:
          • Peter Philander
    • New York
      • Albany, New York, United States, 12203
        • Recruiting
        • Albany Medical College, Division of Community Endocrinology
        • Contact:
          • Phone Number: 518-264-4420
        • Principal Investigator:
          • Robert Busch
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • Ellipsis Research Group
        • Contact:
          • Phone Number: 718-499-6099
        • Principal Investigator:
          • Jorge Serje
      • Westfield, New York, United States, 14787
        • Recruiting
        • Great Lakes Medical Research, LLC
        • Principal Investigator:
          • Donald Brautigam
        • Contact:
          • Phone Number: 716-326-4890
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Recruiting
        • PharmQuest
        • Contact:
          • Phone Number: 3365748020
        • Principal Investigator:
          • Alexander Vance Murray
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Lucas Research, Inc
        • Contact:
          • Phone Number: 2522225700
        • Principal Investigator:
          • Kathryn Jean Lucas
      • Statesville, North Carolina, United States, 28625
        • Recruiting
        • Accellacare - Piedmont
        • Contact:
          • Phone Number: 7049242105
        • Principal Investigator:
          • Joseph Edward Moran, MD
      • Winston-Salem, North Carolina, United States, 27104
        • Recruiting
        • Wake Forest University Baptist Medical Center (WFUBMC)
        • Principal Investigator:
          • Jamy Ard
        • Contact:
          • Phone Number: 336-716-6722
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Aventiv Research Inc
        • Contact:
          • Phone Number: 614-501-6164
        • Principal Investigator:
          • Sridhar Guduri
    • Oklahoma
      • Moore, Oklahoma, United States, 73160
        • Recruiting
        • Tekton Research, Inc
        • Principal Investigator:
          • Rachel Lacy Anderson
      • Norman, Oklahoma, United States, 73069
        • Recruiting
        • Intend Research, LLC
        • Contact:
          • Phone Number: 405-701-8999
        • Principal Investigator:
          • Lisa Connery
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Recruiting
        • The Corvallis Clinic, P.C.
        • Principal Investigator:
          • Shannon Hopson
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Recruiting
        • Heritage Valley Medical Group, Inc.
        • Contact:
          • Phone Number: 724-770-0935
        • Principal Investigator:
          • Michael J Oliver
      • Pittsburgh, Pennsylvania, United States, 15236
        • Recruiting
        • Office 18
        • Contact:
          • Phone Number: 412-650-6155
        • Principal Investigator:
          • Bryce A. Palchick
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • The Research Center of the Upstate
        • Contact:
          • Phone Number: 864-626-3117
        • Principal Investigator:
          • Harlicia Farley
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Recruiting
        • New Phase Research and Development
        • Principal Investigator:
          • Evelyne M Davidson
        • Contact:
          • Phone Number: 865-200-8364
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
        • Contact:
          • Phone Number: 901-843-1045
        • Principal Investigator:
          • Lisa S. Usdan
    • Texas
      • Austin, Texas, United States, 78759
        • Recruiting
        • Velocity Clinical Research, Austin
        • Principal Investigator:
          • Michael Patrick Zimmerman
        • Contact:
          • Phone Number: 5125068287
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Dallas Diabetes Research Center
        • Contact:
          • Phone Number: 972-566-7799
        • Principal Investigator:
          • Julio Rosenstock
      • Fort Worth, Texas, United States, 76132
        • Recruiting
        • Diabetes and Thyroid Center of Ft. Worth
        • Contact:
          • Phone Number: 817-263-0007
        • Principal Investigator:
          • Anjanette Tan
      • Houston, Texas, United States, 77089
        • Recruiting
        • Clear Brook Medical Associates
        • Principal Investigator:
          • Jawad Sarwar, MD
        • Contact:
          • Phone Number: 281-944-3610
      • Houston, Texas, United States, 77040
        • Recruiting
        • Juno Research
        • Contact:
          • Phone Number: 713-779-5494
        • Principal Investigator:
          • Damaris Vega
      • Houston, Texas, United States, 77079
        • Recruiting
        • Endocrine Ips, Pllc
        • Contact:
          • Phone Number: 713-973-3415
        • Principal Investigator:
          • Amer S Al-Karadsheh
      • Mesquite, Texas, United States, 75149
        • Recruiting
        • Southern Endocrinology Associates
        • Contact:
          • Phone Number: 214-693-0904
        • Principal Investigator:
          • Sumana Gangi
      • Weslaco, Texas, United States, 78596
        • Recruiting
        • Texas Valley Clinical Research
        • Principal Investigator:
          • Eduardo Dusty Luna
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Recruiting
        • Synexus Clinical Research US, Inc.
        • Principal Investigator:
          • Michael Adams
    • Washington
      • Redmond, Washington, United States, 98052
        • Recruiting
        • Eastside Research Associates
        • Contact:
          • Phone Number: 425-869-6828
        • Principal Investigator:
          • Chad Crystal
      • Renton, Washington, United States, 98057
        • Recruiting
        • Rainier Clinical Research Center
        • Contact:
          • Phone Number: 4252511720
        • Principal Investigator:
          • Frances Eileen Broyles

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have Type 2 Diabetes
  • Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol), as determined by the central laboratory at screening.
  • Have been on stable diabetes treatment with metformin ≥1500 milligram (mg)/day during the 90 days prior to screening and maintained through randomization.
  • Are of stable body weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment

Exclusion Criteria:

  • Have Type 1 Diabetes
  • Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema, for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors.
  • Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
  • Have a New York Heart Association functional classification IV congestive heart failure.
  • Have an estimated glomerular filtration rate (eGFR) <45 milliliter/minute (mL/min)/1.73 square meter (m²) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory at screening.
  • Have a serum calcitonin level of ≥35 nanogram/Liter (ng/L), as determined by the central laboratory at screening.
  • Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.

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 Dose 1
Participants will receive orforglipron orally.
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970
Experimental: Orforglipron Dose 2
Participants will receive orforglipron orally.
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970
Active Comparator: Semaglutide Dose 1
Participants will receive semaglutide orally.
Drug: Semaglutide
Administered orally
Active Comparator: Semaglutide Dose 2
Participants will receive semaglutide orally.
Drug: Semaglutide
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 52
Baseline, Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Body Weight
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Fasting Serum Glucose
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in HbA1c
Time Frame: Baseline, Week 52
Baseline, Week 52
Percentage of Participants Who Achieved HbA1c <7.0% 53 millimole/mole (mmol/mol)
Time Frame: Week 52
Week 52
Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol)
Time Frame: Week 52
Week 52
Percentage Change from Baseline in Body Weight
Time Frame: Baseline, Week 52
Baseline, Week 52
Percentage of Participants Who Achieved HbA1c <5.7% (39 mmol/mol)
Time Frame: Week 52
Week 52
Change from Baseline in Daily Average 7-point Self-monitored Blood Glucose (SMBG)
Time Frame: Baseline, Week 52
Baseline, Week 52
Percentage of Participants Who Achieved Weight Loss of ≥5%
Time Frame: Week 52
Week 52
Percentage of Participants Who Achieved Weight Loss of ≥10%
Time Frame: Week 52
Week 52
Percentage of Participants Who Achieved Weight Loss of ≥15%
Time Frame: Week 52
Week 52
Change from Baseline in Diastolic Blood Pressure (DBP)
Time Frame: Baseline, Week 52
Baseline, Week 52
Percentage Change from Baseline in Total Cholesterol
Time Frame: Baseline, Week 52
Baseline, Week 52
Percentage Change from Baseline in High Density Lipoprotein (HDL)-Cholesterol
Time Frame: Baseline, Week 52
Baseline, Week 52
Percentage Change from Baseline in Low Density Lipoprotein (LDL)-Cholesterol
Time Frame: Baseline, Week 52
Baseline, Week 52
Percentage Change from Baseline in Very Low Density Lipoprotein (VLDL)-Cholesterol
Time Frame: Baseline, Week 52
Baseline, Week 52
Percentage Change from Baseline in Non-HDL-Cholesterol
Time Frame: Baseline, Week 52
Baseline, Week 52
Percentage Change from Baseline in Triglycerides
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Short Form 36 Version 2 (SF-36-v2) Acute Form Domain Summary Scores
Time Frame: Baseline, Week 52
Baseline, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

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.

Helpful Links

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)

September 22, 2023

Primary Completion (Estimated)

July 25, 2025

Study Completion (Estimated)

July 25, 2025

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18565
  • J2A-MC-GZGU (Other Identifier: Eli Lilly and Company)
  • U1111-1290-6014 (Other Identifier: UTN Number)

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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