A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes

Last updated: April 16, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Obesity

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Treatment

Placebo

Orforglipron

Clinical Study ID

NCT05872620
18560
2022-502837-24-00
J2A-MC-GZGQ
U1111-1289-8799
  • Ages > 18
  • All Genders

Study Summary

This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²).

  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose bodyweight.

  • Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86mmol/mol) and are on stable treatment for T2D for at least 90 days prior toscreening, consisting of:

  • either diet/exercise alone or

  • up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IVinhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).

Exclusion

Exclusion Criteria:

  • Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, orany other types of diabetes except T2D.

  • Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior toscreening.

  • Are currently receiving or planning to receive treatment for diabetic retinopathyand/or macular edema (for example, laster photocoagulation or intravitrealinjections of anti-vascular endothelial growth factor inhibitors).

  • Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.

  • Have had a history of chronic or acute pancreatitis.

Study Design

Total Participants: 1500
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
June 05, 2023
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • CEMEDIAB

    C.a.b.a., Ciudad Aut C1205AAO
    Argentina

    Site Not Available

  • Instituto Centenario

    Caba, Ciudad Autónoma De Buenos Aire 1204
    Argentina

    Site Not Available

  • Mautalen Salud e Investigación

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1128AAF
    Argentina

    Site Not Available

  • Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas Rosario

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Sanatorio San Martin

    Venado Tuerto, Santa Fe 2600
    Argentina

    Site Not Available

  • Centro Medico Privado de Reumatologia

    SAN M. DE Tucuman, Tucumán T4000AXL
    Argentina

    Site Not Available

  • Centro de Investigaciones Médicas Tucuman

    SAN M. DE Tucuman, Tucumán T4000AXL
    Argentina

    Site Not Available

  • Centro de Investigaciones Médicas Tucuman

    San Miguel De Tucumán, Tucumán T4000AXL
    Argentina

    Site Not Available

  • CONEXA Investigacion Clinica S.A.

    Buenos Aires, 1012
    Argentina

    Site Not Available

  • Centro Diabetológico Dr. Waitman

    Córdoba, 5000
    Argentina

    Site Not Available

  • Clínica Universitaria Reina Fabiola

    Córdoba, X50004FHP
    Argentina

    Site Not Available

  • Centro de Diagnóstico y Rehabilitación (CEDIR)

    Santa Fe, 3000
    Argentina

    Site Not Available

  • Emeritus Research

    Botany, New South Wales 2019
    Australia

    Site Not Available

  • Optimus Clinical Research

    Botany, New South Wales 2019
    Australia

    Site Not Available

  • The AIM Centre / Hunter Diabetes Centre

    Merewether, New South Wales 2291
    Australia

    Site Not Available

  • Core Research Group

    Brisbane, Queensland 4064
    Australia

    Site Not Available

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland 4029
    Australia

    Site Not Available

  • Logan Hospital

    Meadowbrook, Queensland 4131
    Australia

    Site Not Available

  • Southern Adelaide Diabetes & Endocrine Services

    Oaklands Park, South Australia 5046
    Australia

    Site Not Available

  • Box Hill Hospital

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Emeritus Research

    Camberwell, Victoria 3124
    Australia

    Site Not Available

  • Austin Health - Repatriation Hospital

    Heidelberg West, Victoria 3081
    Australia

    Site Not Available

  • Baker Heart and Diabetes Institute

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Baker IDI Heart and Diabetes Institute - Melbourne

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Advara HeartCare Joondalup

    Joondalup, Western Australia 6027
    Australia

    Site Not Available

  • GenesisCare

    Joondalup, Western Australia 6027
    Australia

    Site Not Available

  • Centro de Pesquisa Clinica do Brasil

    Brasilia, Distrito Federal 71625-175
    Brazil

    Site Not Available

  • Cendi - Endocrinologia e Diabetes

    Goiânia, Goiás 74230-035
    Brazil

    Site Not Available

  • Instituto Lóbus

    Volta Redonda, Rio De Janeiro 27253-003
    Brazil

    Site Not Available

  • Instituto Méderi de Pesquisa e Saúde

    Passo Fundo, Rio Grande Do Sul 99010-120
    Brazil

    Site Not Available

  • Instituto de Pesquisa clinica de Campinas

    Campinas, São Paulo 13060-080
    Brazil

    Site Not Available

  • Centro de Pesquisa Clínica de Marília - CPCLIM

    Marília, São Paulo 17504-072
    Brazil

    Site Not Available

  • Pesquisare Saude

    Santo André, São Paulo 09080-110
    Brazil

    Site Not Available

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010
    Brazil

    Site Not Available

  • Hospital das Clinicas FMUSP

    São Paulo, 04266-010
    Brazil

    Site Not Available

  • The Second People's Hospital of Hefei

    Hefei, Anhui 230011
    China

    Site Not Available

  • Chinese PLA General Hospital

    Beijing, Beijing 100853
    China

    Site Not Available

  • Chongqing General Hospital

    Chongqing, Chongqing 400014
    China

    Site Not Available

  • ShenZhen People's Hospital

    Shenzhen, Guangdong 518020
    China

    Site Not Available

  • Hainan General Hospital

    Haikou, Hainan 570311
    China

    Site Not Available

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • The Fourth Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang, Henan 471003
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang Shi, Henan 471003
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450014
    China

    Site Not Available

  • Jiangsu Province Official Hospital

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • Nanjing First Hospital

    Nanjing, Jiangsu 210006
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210011
    China

    Site Not Available

  • Nantong First People's Hospital

    Nantong, Jiangsu 226001
    China

    Site Not Available

  • Wuxi People's Hospital

    Wuxi, Jiangsu 214023
    China

    Site Not Available

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Dalian Municipal Central Hospital Affiliated of Dalian Medical University

    Dalian, Liaoning 116033
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Tianjin Medical University Zhu Xianyi Memorial Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan 650034
    China

    Site Not Available

  • MUDr. Alena Vachova

    Ceske Budejovice, Jihočeský 37011
    Czechia

    Site Not Available

  • MUDr. Tomas Edelsberger

    Krnov, Moravskosl 79401
    Czechia

    Site Not Available

  • Diahelp s.r.o

    Pardubice V, Pardubice 530 02
    Czechia

    Site Not Available

  • Dialine - Interni a diabetologicka ambulance

    Pilsen, Plzeň-město 301 00
    Czechia

    Site Not Available

  • Diabet2 s.r.o., diabetologicka a interni ambulance

    Praha, Praha 1 11000
    Czechia

    Site Not Available

  • Milan Kvapil s.r.o., Diabetologicka ambulance

    Praha, Praha 4 14900
    Czechia

    Site Not Available

  • ResTrial s.r.o.

    Praha, Praha 8 18100
    Czechia

    Site Not Available

  • MUDr. Sabina Palova

    Jilove u Prahy, Praha-západ 252 42
    Czechia

    Site Not Available

  • Milan Kvapil s.r.o., Diabetologicka ambulance Pribram

    Pribram, Středočeský Kraj 26201
    Czechia

    Site Not Available

  • Endokrinologie MUDr. Rehorkova s.r.o.

    Hradec Kralove, 500 12
    Czechia

    Site Not Available

  • Diahelp s.r.o

    Pardubice, 530 02
    Czechia

    Site Not Available

  • MUDr. Jitka Zemanová - diabetologie a interna s.r.o.

    Plzen, 326 00
    Czechia

    Site Not Available

  • Nemocnice Cesky Krumlov

    Český Krumlov, 381 01
    Czechia

    Site Not Available

  • Nemocnice Cesky Krumlov, a.s.

    Český Krumlov, 381 01
    Czechia

    Active - Recruiting

  • CDG Studienambulanz Hartard

    München, Bayern 80809
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf

    Wallerfing, Bayern 94574
    Germany

    Site Not Available

  • Ceda-Research

    Pohlheim, Hessen 35415
    Germany

    Site Not Available

  • Diabetologische Schwerpunktpraxis Marck Linn Pickel

    Pohlheim, Hessen 35415
    Germany

    Site Not Available

  • Diabetologische Schwerpunktpraxis Marck Linn Pickel

    Pulheim, Hessen 35415
    Germany

    Site Not Available

  • Institut für Diabetesforschung GmbH Münster

    Münster, Nordrhein- 48145
    Germany

    Site Not Available

  • InnoDiab Forschung Gmbh

    Essen, Nordrhein-Westfalen 45136
    Germany

    Site Not Available

  • Medizentrum Essen Borbeck

    Essen, Nordrhein-Westfalen 45355
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln

    Köln, Nordrhein-Westfalen 50937
    Germany

    Site Not Available

  • University Hospital of Cologne

    Köln, Nordrhein-Westfalen 50937
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dr. med. Ralf Denger und Dr. med. Thomas Pfitzner

    Friedrichsthal, Saarland 66299
    Germany

    Site Not Available

  • Practice Dr.med. Denger and Dr.med. Pfitzner

    Friedrichsthal, Saarland 66299
    Germany

    Site Not Available

  • AmBeNet GmbH

    Leipzig, Sachsen 04107
    Germany

    Site Not Available

  • Arztpraxis Christine Kosch Pirna

    Pirna, Sachsen 01796
    Germany

    Site Not Available

  • Private Practice - Dr. Christine Kosch

    Pirna, Sachsen 01796
    Germany

    Site Not Available

  • Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels

    Hohenmölsen, Sachsen-Anhalt 06679
    Germany

    Site Not Available

  • SMO.MD GmbH

    Magdeburg, Sachsen-Anhalt 39120
    Germany

    Site Not Available

  • Universität zu Lübeck - Institut für Endokrinologie und Diabetes

    Lübeck, Schleswig-Holstein 23562
    Germany

    Site Not Available

  • RED-Institut GmbH

    Oldenburg, Schleswig-Holstein 23758
    Germany

    Site Not Available

  • Diabetes Zentrum Dr. Tews

    Gelnhausen, 63571
    Germany

    Site Not Available

  • Diabetes Zentrum Wilhelmsburg

    Hamburg, 21109
    Germany

    Site Not Available

  • Athens Medical Center

    Athens, Attikí 151 25
    Greece

    Site Not Available

  • Hippokration University Hopsital

    Thessaloniki, Kentrikí Makedonía 54642
    Greece

    Site Not Available

  • Ippokrateio General Hospital of Thessaloniki

    Thessaloniki, Kentrikí Makedonía 54642
    Greece

    Site Not Available

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, Thessaloníki 546 45
    Greece

    Site Not Available

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, Thessaloníki 564 29
    Greece

    Site Not Available

  • Thermi Clinic

    Thessaloniki, Thessaloníki 570 01
    Greece

    Site Not Available

  • University General Hospital of Larissa

    Larissa, Thessalía 41110
    Greece

    Site Not Available

  • 424 Military General Training Hospital

    Thessaloniki, 564 29
    Greece

    Site Not Available

  • All India Institute of Medical Sciences

    Raipur, Chhattisgarh 492099
    India

    Site Not Available

  • Dr B. L. Kapur Memorial Hospital

    New Delhi, Delhi 110005
    India

    Site Not Available

  • Shree Krishna Hospital

    Anand, Gujarat 388325
    India

    Site Not Available

  • Shree Krishna Hospital

    Karamsad, Gujarat 388325
    India

    Site Not Available

  • Medstar Speciality Hospital

    Bangalore, Karnataka 560092
    India

    Site Not Available

  • Karnataka Institute of Medical Sciences

    Hubli, Karnataka 580021
    India

    Site Not Available

  • TOTALL Diabetes Hormone Institute

    Indore, Madhya Pradesh 452010
    India

    Site Not Available

  • Government Medical College, Aurangabad

    Aurangabad, Maharashtra 431001
    India

    Site Not Available

  • BSES MG Hospital

    Mumbai, Maharashtra 400058
    India

    Site Not Available

  • Topiwala National Medical College & B. Y. L. Nair Charitable Hospital

    Mumbai, Maharashtra 400008
    India

    Site Not Available

  • All India Institute of Medical Sciences (AIIMS) - Nagpur

    Nagpur, Maharashtra 441108
    India

    Site Not Available

  • Sahyadri Super Speciality Hospital

    Pune, Maharashtra 411004
    India

    Site Not Available

  • Arthur Asirvatham Hospital

    Madurai, Tamil Nadu 625020
    India

    Site Not Available

  • Kumudini Devi Diabetes Research Center

    Hyderabad, Telangana 500082
    India

    Site Not Available

  • Fortis Hospital

    Noida, Uttar Pradesh 201301
    India

    Site Not Available

  • Fortis Hospital

    Delhi, 110088
    India

    Site Not Available

  • Wonju Severance Christian Hospital

    Wonju, Kang-won-do 26426
    Korea, Republic of

    Active - Recruiting

  • Yonsei University-Wonju Severance Christian Hospital

    Wonju, Kang-won-do 26426
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do 13620
    Korea, Republic of

    Site Not Available

  • Yeungnam Univeristy Medical Center

    Gyeongsan-si, Kyǒngsangbuk-do 42415
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 02841
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Hospital at Gangdong

    Seoul, Seoul-teukbyeolsi [Seoul] 134-090
    Korea, Republic of

    Site Not Available

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 06591
    Korea, Republic of

    Site Not Available

  • Advanced Clinical Research, LLC

    Bayamón, 00959
    Puerto Rico

    Site Not Available

  • Isis Clinical Research Center

    Guaynabo, 00968
    Puerto Rico

    Site Not Available

  • Private Practice - Dr. Paola Mansilla-Letelier

    Guaynabo, 00968
    Puerto Rico

    Site Not Available

  • Cahaba Research - Pelham

    Pelham, Alabama 35124
    United States

    Site Not Available

  • Novak Clinical Research - Tucson - North La Cholla Boulevard

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Yuma Clinical Trials

    Yuma, Arizona 85364
    United States

    Site Not Available

  • AMCR Institute

    Escondido, California 92025
    United States

    Site Not Available

  • National Research Institute - Huntington Park

    Huntington Park, California 90255
    United States

    Site Not Available

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California 90255
    United States

    Site Not Available

  • National Research Institute - Wilshire

    Los Angeles, California 90057
    United States

    Site Not Available

  • Velocity Clinical Research, Westlake

    Los Angeles, California 90057
    United States

    Site Not Available

  • Catalina Research Institute, LLC

    Montclair, California 91763
    United States

    Site Not Available

  • University Clinical Investigators, Inc.

    Tustin, California 92780
    United States

    Site Not Available

  • Encore Medical Research

    Hollywood, Florida 33024
    United States

    Site Not Available

  • East Coast Institute for Research, LLC

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • South Florida Clinical Research Institute

    Margate, Florida 33063
    United States

    Site Not Available

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Balanced Life Health Care Solutions/SKYCRNG

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia 30076
    United States

    Site Not Available

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Site Not Available

  • Pacific Diabetes & Endocrine Center

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Solaris Clinical Research

    Meridian, Idaho 83646
    United States

    Site Not Available

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland 21239
    United States

    Site Not Available

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan 48098
    United States

    Site Not Available

  • StudyMetrix Research

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Las Vegas Medical Research

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Albuquerque Neuroscience Inc.

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • IMA Clinical Research

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Albany Medical College, Division of Community Endocrinology

    Albany, New York 12203
    United States

    Site Not Available

  • Albany Stratton VA Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • NYC Research INC

    Long Island City, New York 11106
    United States

    Site Not Available

  • Accellacare - Raleigh

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • Summit Headlands

    Portland, Oregon 97210
    United States

    Site Not Available

  • Summit Research Network

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Dallas Diabetes Research Center

    Dallas, Texas 75230
    United States

    Site Not Available

  • Velocity Clinical Research, Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Epic Medical Research - DeSoto

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Soma Clinical Trials

    Denison, Texas 75020
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Houston, Texas 77043
    United States

    Site Not Available

  • Epic Medical Research

    Red Oak, Texas 75154
    United States

    Site Not Available

  • Diabetes and Glandular Disease Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • VIP Trials

    San Antonio, Texas 78230
    United States

    Site Not Available

  • Charlottesville Medical Research

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • Universal Research Group

    Tacoma, Washington 98405
    United States

    Site Not Available

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