A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)

April 15, 2024 updated by: Eli Lilly and Company

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)

This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3000

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

  • Brazil
      • Rio de Janeiro, Brazil, 22061-080
        • Hospital São Lucas de Copacabana
      • São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clínica
        • Contact:
          • Phone Number: 551127766801
        • Principal Investigator:
          • Gustavo Akerman Augusto
      • São Paulo, Brazil, 04266-010
        • CEPIC - Centro Paulista de Investigacao Clinica
        • Contact:
          • Phone Number: 551122713450
        • Principal Investigator:
          • Breno Balabem Alves
      • São Paulo, Brazil, 05403-000
        • Hospital das Clinicas FMUSP
        • Contact:
          • Phone Number: 551126617845
        • Principal Investigator:
          • Cintia Cercato
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-350
        • Private Practice - Dr.Miguel N. Hissa
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055450
        • CEDOES
        • Contact:
          • Phone Number: 55279993333
        • Principal Investigator:
          • queulla garret santos
    • Maranhão
      • Bequimao, Maranhão, Brazil, 65060-645
        • Hospital São Domingos
        • Contact:
          • Phone Number: 559832168611
        • Principal Investigator:
          • Jose Alb Figueiredo Neto
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-480
        • Cline Research Center
        • Contact:
          • Phone Number: 554130273930
        • Principal Investigator:
          • Silmara Ap Leite
      • Curitiba, Paraná, Brazil, 80045170
        • Pesquisa Clínica em Diabetes - Dra Rosângela Réa
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
        • Nucleo de Pesquisa Clinica do Rio Grande do Sul
        • Contact:
          • Phone Number: 555137796400
        • Principal Investigator:
          • Luis Henrique Canani
    • São Paulo
      • Campinas, São Paulo, Brazil, 13060-803
        • Centro de Pesquisa Sao Lucas
        • Contact:
          • Phone Number: 551933438688
        • Principal Investigator:
          • Danilo Gla Villagelin Neto
      • Jaú, São Paulo, Brazil, 17201130
        • CECIP - Centro de Estudos do Interior Paulista
      • Sao Bernardo do Campo, São Paulo, Brazil, 09715-090
        • Centro Multidisciplinar de Estudos Clinicos
        • Contact:
          • Phone Number: 551149304243
        • Principal Investigator:
          • Claudia de Brito
      • Votuporanga, São Paulo, Brazil, 15501-405
        • Integral Pesquisa e Ensino
        • Contact:
          • Phone Number: 5501734235306
        • Principal Investigator:
          • GRACIELLY DE SOUZA PANTANO
  • China
    • Anhui
      • Hefei, Anhui, China, 230011
        • The Second People's Hospital of Hefei
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General hospital
        • Principal Investigator:
          • Yiming Mu
    • Chongqing
      • Chongqing, Chongqing, China, 404117
        • Chongqing General Hospital
    • Guangdong
      • Shenzhen, Guangdong, China, 518020
        • ShenZhen People's Hospital
    • Hainan
      • Haikou, Hainan, China, 570311
        • Hainan General Hospital
        • Principal Investigator:
          • Kaining Chen
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • The Fourth Hospital of Harbin Medical University
    • Henan
      • Luoyang Shi, Henan, China, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Zhengzhou, Henan, China, 450014
        • The Second Affiliated Hospital of Zhengzhou University
        • Contact:
          • Phone Number: 15838123695
        • Principal Investigator:
          • Qingju Li
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital
        • Principal Investigator:
          • Jianhua Ma
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
        • Principal Investigator:
          • Yibing Lu
        • Contact:
          • Phone Number: 18951762690
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University
        • Principal Investigator:
          • Bimin Shi
      • Zhenjiang, Jiangsu, China, 212000
        • Affiliated Hospital of Jiangsu University
        • Principal Investigator:
          • Guoyue Yuan
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial People's Hospital
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
        • Contact:
          • Phone Number: 15318816218
        • Principal Investigator:
          • Xiaolin Dong
    • Shanghai
      • Shanghai, Shanghai, China, 201800
        • Jiading District Central Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Tianjin Medical University General Hospital
        • Principal Investigator:
          • Ming Liu
        • Contact:
          • Phone Number: 18322017516
      • Tianjin, Tianjin, China, 300134
        • Tianjin Medical University Zhu Xianyi Memorial Hospital
    • Yunnan
      • Kunming, Yunnan, China, 650034
        • The First People's Hospital of Yunnan Province
        • Principal Investigator:
          • Heng Su
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310013
        • Zhejiang Hospital
        • Principal Investigator:
          • Tian Feng Wu
      • Ningbo, Zhejiang, China, 315010
        • Ningbo First Hospital
        • Contact:
          • Phone Number: 13757426626
        • Principal Investigator:
          • Li Li
  • India
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, India, 522001
        • Endolife Speciality Hospitals
        • Principal Investigator:
          • Kongara Srikanth
    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Victoria Hospital, Bangalore Medical College And Research Institute
        • Principal Investigator:
          • Chandrashekar Mathod
      • Mysore, Karnataka, India, 570001
        • Mysore Medical College
        • Principal Investigator:
          • Sumaiya Anjum
    • Maharashtra
      • Nagpur, Maharashtra, India, 441108
        • All India Institute of Medical Sciences (AIIMS) - Nagpur
        • Principal Investigator:
          • Rajashree Sanjay Khot
      • Nagpur, Maharashtra, India, 440015
        • Central India Cardiology and Research Institute
      • Pune, Maharashtra, India, 411004
        • Deenanath Mangeshkar Hospital & Research Centre
        • Principal Investigator:
          • Vaishali Chetan Deshmukh
      • Pune, Maharashtra, India, 411004
        • Sahyadri Super Speciality Hospital
        • Principal Investigator:
          • Shashank Shah
      • Pune, Maharashtra, India, 411057
        • Lifepoint Multispeciality Hospital
        • Principal Investigator:
          • Amol Laxmanrao Dange
        • Contact:
          • Phone Number: 02066434366
  • Japan
      • Fukuoka, Japan, 812-0025
        • Boocs Clinic Fukuoka
        • Principal Investigator:
          • Minoru Fujino
    • Fukuoka
      • Kasuya, Fukuoka, Japan, 811-2310
        • Oishi Clinic
        • Contact:
          • Phone Number: 0929381900
        • Principal Investigator:
          • Yayoi Oishi
    • Hiroshima
      • Aki-gun, Hiroshima, Japan, 735-0017
        • Mazda Hospital
        • Principal Investigator:
          • Hideyuki Tsuji
    • Ibaraki
      • Tsuchiura, Ibaraki, Japan, 300-0012
        • Tsuchiura Medical & Health Care Center
    • Kagawa
      • Takamatsu, Kagawa, Japan, 760-0076
        • NTT Nishinihon Takamatsu Clinic
        • Principal Investigator:
          • Toshiki Fukui
      • Zentsuji, Kagawa, Japan, 765-0071
        • Iwamoto Internal Medicine Clinic
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0064
        • Yokohama Minoru Clinic
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0853
        • Medical Corporation Heishinkai OCROM Clinic
        • Principal Investigator:
          • Satoshi Inoue
    • Saitama
      • Soka, Saitama, Japan, 340-0015
        • Sugiura Internal Medicine Clinic
    • Tokyo
      • Adachi-ku, Tokyo, Japan, 120-0022
        • Adachi Kyosai Hospital
        • Contact:
          • Phone Number: 0338816116
        • Principal Investigator:
          • Manabu Yamamoto
      • Chuo-ku, Tokyo, Japan, 104-0031
        • Fukuwa Clinic
        • Principal Investigator:
          • Yasushi Fukushima
        • Contact:
          • Phone Number: 81362623751
      • Chuo-ku, Tokyo, Japan, 103-0028
        • Medical Corporation Chiseikai Tokyo Center Clinic
        • Principal Investigator:
          • Yuichi Takahashi
      • Meguro-ku, Tokyo, Japan, 153-0053
        • Yutenji Medical Clinic
        • Contact:
          • Phone Number: 81357245222
        • Principal Investigator:
          • Kotaro Shimokawa
      • Mitaka, Tokyo, Japan, 181-0013
        • Kanno Naika
        • Principal Investigator:
          • Kazuo Kanno
      • Setagaya-ku, Tokyo, Japan, 155-0031
        • Shimokitazawa Tomo Clinic
      • Shinjuku-ku, Tokyo, Japan, 160-0008
        • Heishinkai Medical Group ToCROM Clinic
        • Principal Investigator:
          • Osamu Matsuoka
  • Korea, Republic of
    • Incheon-gw
      • Namdong-gu, Incheon-gw, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
    • Kyǒnggi-do
      • Anyang-si, Kyǒnggi-do, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
        • Principal Investigator:
          • Kyung Hee Park
      • Suwon, Kyǒnggi-do, Korea, Republic of, 16499
        • Ajou University Hospital
        • Contact:
          • Phone Number: 82312195309
        • Principal Investigator:
          • Bom Taeck Kim
    • Kyǒngsangnam-do
      • Busan, Kyǒngsangnam-do, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital
        • Principal Investigator:
          • Sang Yeoup Lee
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03080
        • Seoul National University Hospital
    • Taejǒn-Kwangyǒkshi
      • Seo-gu, Taejǒn-Kwangyǒkshi, Korea, Republic of, 35365
        • Konyang University Hospital
  • Puerto Rico
      • Dorado, Puerto Rico, 00646
        • Dorado Medical Complex
        • Contact:
          • Phone Number: 7872781576
        • Principal Investigator:
          • Luis A Pagan-Cardona
      • San Juan, Puerto Rico, 00917
        • GCM Medical Group, PSC - Hato Rey Site
  • Slovakia
      • Bratislava, Slovakia, 831 03
        • MediTask
        • Contact:
          • Phone Number: 421948411118
        • Principal Investigator:
          • Jozef Lacka
    • Banskobystrický Kraj
      • Lucenec, Banskobystrický Kraj, Slovakia, 984 01
        • Nemocnica s poliklinikou Lucenec
        • Contact:
          • Phone Number: 421474311323
        • Principal Investigator:
          • Andrea Cervenakova
    • Bratislavský Kraj
      • Bratislava, Bratislavský Kraj, Slovakia, 811 08
        • Metabol KLINIK
        • Contact:
          • Phone Number: 00421903838291
        • Principal Investigator:
          • Lubomira Fabryova
    • Košický Kr
      • Roznava, Košický Kr, Slovakia, 048 01
        • DIAB sro
        • Contact:
          • Phone Number: 421587329625
        • Principal Investigator:
          • Dalibor Sosovec
    • Košický Kraj
      • Kosice, Košický Kraj, Slovakia, 04001
        • Human Care s.r.o.
        • Contact:
          • Phone Number: 421905667695
        • Principal Investigator:
          • Viera Donicova
      • Trebisov, Košický Kraj, Slovakia, 075 01
        • Areteus s.r.o.
        • Contact:
          • Phone Number: 42176671611
        • Principal Investigator:
          • Dasa Skripova
    • Prešovský Kraj
      • Sabinov, Prešovský Kraj, Slovakia, 083 01
        • MEDI-DIA s.r.o.
        • Contact:
          • Phone Number: 421907230520
        • Principal Investigator:
          • Martina Merciakova
    • Trenčiansky Kraj
      • Puchov, Trenčiansky Kraj, Slovakia, 020 01
        • DIA-MED CENTRUM s.r.o.
        • Contact:
          • Phone Number: 421423810145
        • Principal Investigator:
          • Ludmila Kubincova
  • Spain
      • València, Spain, 46026
        • Hospital Universitari i Politècnic La Fe
        • Principal Investigator:
          • Juan Francisco Merino-Torres
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Spain, 15006
        • CHUAC-Complejo Hospitalario Universitario A Coruña
        • Contact:
          • Phone Number: 655624017
        • Principal Investigator:
          • Alfonso Soto Gonzalez
      • Ferrol, A Coruña [La Coruña], Spain, 15405
        • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
        • Principal Investigator:
          • DIEGO BELLIDO GUERRERO
    • Almería
      • Almeria, Almería, Spain, 04009
        • Centro Periferico De Especialidades Bola Azul
        • Contact:
          • Phone Number: 0034678510067
        • Principal Investigator:
          • Pedro Mezquita-Raya
    • Andalucía
      • Malaga, Andalucía, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Sevilla, Andalucía, Spain, 41010
        • Hospital Quiron Infanta Luisa
        • Contact:
          • Phone Number: 670502836
        • Principal Investigator:
          • MARGARITA RIVAS FERNANDEZ
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Hospital Germans Trias i Pujol
        • Contact:
          • Phone Number: 34934978860
        • Principal Investigator:
          • Berta Soldevila
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Phone Number: 34697817352
        • Principal Investigator:
          • ANDREEA CIUDIN
      • Barcelona, Barcelona [Barcelona], Spain, 08022
        • Centro Médico Teknon
        • Contact:
          • Phone Number: 933933155
        • Principal Investigator:
          • Guillem Cuatrecasas
    • Castilla Y León
      • Valladolid, Castilla Y León, Spain, 47010
        • Hospital Clínico Universitario de Valladolid
        • Contact:
          • Phone Number: 983420000
        • Principal Investigator:
          • Daniel De luis roman
    • Cádiz
      • Sanlúcar de Barrameda, Cádiz, Spain, 11540
        • Hospital Virgen del Camino
        • Contact:
          • Phone Number: 956048000
        • Principal Investigator:
          • Manuel Beltran Robles
      • Villamartin, Cádiz, Spain, 11650
        • Hospital Virgen de las Montañas
        • Contact:
          • Phone Number: 956041000
        • Principal Investigator:
          • Enrique Garcia del Rio
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46014
        • Hospital General Universitario De Valencia
        • Contact:
          • Phone Number: 9631318004
        • Principal Investigator:
          • Juan Carlos Ferrer Garcia
  • Taiwan
      • Changhua, Taiwan, 50006
        • Changhua Christian Hospital
        • Contact:
          • Phone Number: 886989712039
        • Principal Investigator:
          • Shih-Te Tu
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
        • Contact:
          • Phone Number: 88662353535
        • Principal Investigator:
          • Yi-Ching Yang
    • Chiayi
      • Chiayi City, Chiayi, Taiwan, 600
        • Chiayi Christian Hospital
        • Contact:
          • Phone Number: 88652765041
        • Principal Investigator:
          • Chu-Kuang Chou
    • Kaohsiung
      • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
        • Chang Gung Memorial Hospital at Kaohsiung
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210
        • The Institute for Liver Health dba Arizona Clinical Trials
        • Principal Investigator:
          • Yessica Sachdeva
      • Sun City West, Arizona, United States, 85375
        • Clinical Research Institute of Arizona (CRI) - Sun City West
        • Principal Investigator:
          • Jalal Abbas
    • California
      • Concord, California, United States, 94520
        • John Muir Physician Network Research Center
        • Principal Investigator:
          • Yeran Bao
      • Escondido, California, United States, 92025
        • AMCR Institute
        • Contact:
          • Phone Number: 760-466-1520
        • Principal Investigator:
          • Timothy S. Bailey
      • Greenbrae, California, United States, 94904
        • NorCal Medical Research, Inc
        • Contact:
          • Phone Number: 415-461-1585
        • Principal Investigator:
          • Linda Gaudiani
      • Huntington Park, California, United States, 90255
        • National Research Institute - Huntington Park
      • Los Angeles, California, United States, 90057
        • National Research Institute - Wilshire
      • Montclair, California, United States, 91763
        • Catalina Research Institute, LLC
        • Contact:
          • Phone Number: 909-590-8409
        • Principal Investigator:
          • Rizwana H Mohseni
      • San Ramon, California, United States, 94583
        • Norcal Endocrinology & Internal Medicine
        • Contact:
          • Phone Number: 707-628-6428
        • Principal Investigator:
          • Yshay Shlesinger
      • Tustin, California, United States, 92780
        • University Clinical Investigators, Inc.
        • Contact:
          • Phone Number: 714-734-7944
        • Principal Investigator:
          • Joanna T. Van
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
        • Contact:
          • Phone Number: 303-724-4651
        • Principal Investigator:
          • Neda Rasouli
    • Florida
      • Miami, Florida, United States, 33186
        • New Age Medical Research Corporation
        • Contact:
          • Phone Number: 305-596-9901
        • Principal Investigator:
          • Janet K. Gersten
      • Miramar, Florida, United States, 33027
        • South Broward Research
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
        • Contact:
          • Phone Number: 3526295800
        • Principal Investigator:
          • David Lucius Oliver
      • Tampa, Florida, United States, 33619
        • Jedidiah Clinical Research - Tampa - Bay Plaza
        • Contact:
          • Phone Number: 813-676-0234
        • Principal Investigator:
          • Andrew D Henry
      • Winter Park, Florida, United States, 32789
        • Clinical Site Partners, LLC dba Flourish Research
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Physicians Research Associates
        • Contact:
          • Phone Number: 678-252-2375
        • Principal Investigator:
          • Ola Odugbesan
      • Macon, Georgia, United States, 31210
        • East Coast Institute for Research at The Jones Center
      • Union City, Georgia, United States, 30291
        • Rophe Adult and Pediatric Medicine/SKYCRNG
        • Principal Investigator:
          • Dwight Blake
        • Contact:
          • Phone Number: 470-317-3604
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
        • Contact:
          • Phone Number: 8085316886
        • Principal Investigator:
          • Cindy H. T. Pau
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials
        • Principal Investigator:
          • Gary W Soucie
        • Contact:
          • Phone Number: 208-643-0006
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center
        • Contact:
          • Phone Number: 785-354-9591
        • Principal Investigator:
          • Michael Cox
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center - Central Office
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center
        • Contact:
          • Phone Number: 225-763-2831
        • Principal Investigator:
          • Daniel Hsia
      • Lake Charles, Louisiana, United States, 70601
        • Care Access - Lake Charles
        • Principal Investigator:
          • Jason Morris
        • Contact:
          • Phone Number: 337-602-6642
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • MedStar Health Research Institute (MedStar Physician Based Research Network)
        • Contact:
          • Phone Number: 3015607322
        • Principal Investigator:
          • Jean Young Park
      • Rockville, Maryland, United States, 20852
        • Endocrine and Metabolic Consultants
        • Contact:
          • Phone Number: 301-770-7373
        • Principal Investigator:
          • MICHAEL A DEMPSEY
    • Michigan
      • Troy, Michigan, United States, 48098
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
        • Contact:
          • Phone Number: 248-312-0025
        • Principal Investigator:
          • Neil J. Fraser
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • SKY Clinical Research Network Group-Quinn
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Medical Research
        • Principal Investigator:
          • Bharat R Mocherla
        • Contact:
          • Phone Number: 702-750-0222
    • New York
      • Lake Success, New York, United States, 11042
        • Long Island Cardiovascular Consultants
        • Contact:
          • Phone Number: 516-627-2121
        • Principal Investigator:
          • Kenneth Cohen
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
        • Contact:
          • Phone Number: 646-962-2111
        • Principal Investigator:
          • Alpana Shukla
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Intend Research, LLC
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes Research Center
      • Dallas, Texas, United States, 75251
        • Cedar Health Research
        • Principal Investigator:
          • Michele D. Reynolds
        • Contact:
          • Phone Number: 972-241-1221
      • Dallas, Texas, United States, 75208
        • Thyroid, Endocrinology, and Diabetes
        • Contact:
          • Phone Number: 972-266-8765
        • Principal Investigator:
          • Steve Fordan
      • Houston, Texas, United States, 77054
        • Juno Research
        • Contact:
          • Phone Number: 713-779-5494
        • Principal Investigator:
          • Rocio Harbison
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
        • Contact:
          • Phone Number: 210-545-4900
        • Principal Investigator:
          • Michelle Welch
      • Wylie, Texas, United States, 75098
        • Soma Clinical Trials
        • Contact:
          • Phone Number: 469-449-3645
        • Principal Investigator:
          • Tanvir Ahmad
    • Utah
      • Draper, Utah, United States, 84020
        • Physicians' Research Options
        • Contact:
          • Phone Number: 801-352-9228
        • Principal Investigator:
          • David B Jack
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads, Inc.
        • Contact:
          • Phone Number: 7575918100
        • Principal Investigator:
          • George Har Freeman
    • Washington
      • Redmond, Washington, United States, 98052
        • Eastside Research Associates
        • Contact:
          • Phone Number: 425-869-6828
        • Principal Investigator:
          • Chad Crystal

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 a BMI

    • ≥30.0 kilogram/square meter (kg/m²),

    • ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:

      • Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria:

  • Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
  • Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
  • Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN)2 syndrome.
  • Have had a history of chronic or acute pancreatitis.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orforglipron Dose 1
Participant will receive orforglipron administered orally.
Drug: Orforglipron
Administered orally.
Other Names:
  • LY3502970
Experimental: Orforglipron Dose 2
Participant will receive orforglipron administered orally.
Drug: Orforglipron
Administered orally.
Other Names:
  • LY3502970
Experimental: Orforglipron Dose 3
Participant will receive orforglipron administered orally.
Drug: Orforglipron
Administered orally.
Other Names:
  • LY3502970
Placebo Comparator: Placebo
Participants will be given placebo.
Drug: Placebo
Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Percent Change from Baseline in Body Weight
Time Frame: Baseline to Week 72
Baseline to Week 72

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 72
Baseline, Week 72
Mean Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 72
Baseline, Week 72
Mean Percent Change from Baseline in Fasting non-HDL Cholesterol
Time Frame: Baseline, Week 72
Baseline, Week 72
Mean Percent Change from Baseline in Fasting Triglycerides
Time Frame: Baseline, Week 72
Baseline, Week 72
Mean Change from Baseline in Hemoglobin A1c (HbA1c) %
Time Frame: Baseline, Week 72
Baseline, Week 72
Mean Change from Baseline in Fasting Glucose
Time Frame: Baseline, Week 72
Baseline, Week 72
Mean Percent Change from Baseline in Fasting Insulin
Time Frame: Baseline, Week 72
Baseline, Week 72
Mean Change from Baseline in Diastolic Blood Pressure (DBP)
Time Frame: Baseline, Week 72
Baseline, Week 72
Mean Change from Baseline in Short Form Version 2 (SF-36v2) Acute Form Domain Scores
Time Frame: Baseline, Week 72
Baseline, Week 72

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)

June 5, 2023

Primary Completion (Estimated)

September 12, 2025

Study Completion (Estimated)

September 24, 2027

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

May 12, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18559
  • J2A-MC-GZGP (Other Identifier: Eli Lilly and Company)
  • 2022-502839-19-00 (Other Identifier: Eli Lilly and Company)
  • U1111-1289-8877 (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

ata 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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