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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05872620
Other study ID # 18560
Secondary ID J2A-MC-GZGQ2022-
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date June 5, 2023
Est. completion date June 2025

Study information

Verified date April 2024
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1500
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 body weight. - Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c =7% (=53 mmol/mol) to =10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of: - either diet/exercise alone or - up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA). Exclusion Criteria: - Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D. - Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening. - Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laster photocoagulation or intravitreal injections 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


Intervention

Drug:
Orforglipron
Administered orally
Placebo
Administered orally

Locations

Country Name City State
Argentina CONEXA Investigacion Clinica S.A. Buenos Aires
Argentina Mautalen Salud e Investigación Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina CEMEDIAB C.a.b.a. Ciudad Aut
Argentina Instituto Centenario Caba Ciudad Autónoma De Buenos Aire
Argentina Centro Diabetológico Dr. Waitman Córdoba
Argentina Clínica Universitaria Reina Fabiola Córdoba
Argentina Instituto de Investigaciones Clinicas Rosario Rosario Santa Fe
Argentina Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica Rosario Santa Fe
Argentina Centro de Investigaciones Médicas Tucuman SAN M. DE Tucuman Tucumán
Argentina Centro de Diagnóstico y Rehabilitación (CEDIR) Santa Fe
Argentina Sanatorio San Martin Venado Tuerto Santa Fe
Australia Optimus Clinical Research Botany New South Wales
Australia Box Hill Hospital Box Hill Victoria
Australia Core Research Group Brisbane Queensland
Australia Royal Brisbane and Women's Hospital Brisbane Queensland
Australia Emeritus Research Camberwell Victoria
Australia Austin Health - Repatriation Hospital Heidelberg West Victoria
Australia GenesisCare Joondalup Western Australia
Australia Logan Hospital Meadowbrook Queensland
Australia Baker IDI Heart and Diabetes Institute - Melbourne Melbourne Victoria
Australia The AIM Centre / Hunter Diabetes Centre Merewether New South Wales
Australia Southern Adelaide Diabetes & Endocrine Services Oaklands Park South Australia
Brazil Centro de Pesquisa Clinica do Brasil Brasilia Distrito Federal
Brazil Cendi - Endocrinologia e Diabetes Goiânia Goiás
Brazil Centro de Pesquisa Clínica de Marília - CPCLIM Marília São Paulo
Brazil Instituto Méderi de Pesquisa e Saúde Passo Fundo Rio Grande Do Sul
Brazil Pesquisare Saude Santo André São Paulo
Brazil Hospital das Clinicas FMUSP São Paulo
Brazil Instituto Lóbus Volta Redonda Rio De Janeiro
China Chinese PLA General Hospital Beijing Beijing
China Chongqing General Hospital Chongqing Chongqing
China Dalian Municipal Central Hospital Affiliated of Dalian Medical University Dalian Liaoning
China The Fourth Hospital of Harbin Medical University Harbin Heilongjiang
China The Second People's Hospital of Hefei Hefei Anhui
China Jinan Central Hospital Jinan Shandong
China The First People's Hospital of Yunnan Province Kunming Yunnan
China The First Affiliated Hospital of Henan University of Science &Technology Luoyang Shi Henan
China Jiangxi Provincial People's Hospital Nanchang Jiangxi
China Jiangsu Province Official Hospital Nanjing Jiangsu
China Nanjing First Hospital Nanjing Jiangsu
China The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
China Nantong First People's Hospital Nantong Jiangsu
China ShenZhen People's Hospital Shenzhen Guangdong
China Tianjin Medical University General Hospital Tianjin Tianjin
China Tianjin Medical University Zhu Xianyi Memorial Hospital Tianjin Tianjin
China Wuxi People's Hospital Wuxi Jiangsu
China The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Czechia MUDr. Alena Vachova Ceske Budejovice Jihoceský
Czechia Nemocnice Cesky Krumlov Ceský Krumlov
Czechia Endokrinologie MUDr. Rehorkova s.r.o. Hradec Kralove
Czechia MUDr. Sabina Palova Jilove u Prahy Praha-západ
Czechia MUDr. Tomas Edelsberger Krnov Moravskosl
Czechia Diahelp s.r.o Pardubice V Pardubice
Czechia Dialine - Interni a diabetologicka ambulance Pilsen Plzen-mesto
Czechia MUDr. Jitka Zemanová - diabetologie a interna s.r.o. Plzen
Czechia Diabet2 s.r.o., diabetologicka a interni ambulance Praha Praha 1
Czechia Milan Kvapil s.r.o., Diabetologicka ambulance Praha Praha 4
Czechia ResTrial s.r.o. Praha Praha 8
Czechia Milan Kvapil s.r.o., Diabetologicka ambulance Pribram Pribram Stredoceský Kraj
Germany InnoDiab Forschung Gmbh Essen Nordrhein-Westfalen
Germany Medizentrum Essen Borbeck Essen Nordrhein-Westfalen
Germany Diabetes Zentrum Dr. Tews Gelnhausen
Germany Diabetes Zentrum Wilhelmsburg Hamburg
Germany Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weißenfels Hohenmölsen Sachsen-Anhalt
Germany University Hospital of Cologne Köln Nordrhein-Westfalen
Germany AmBeNet GmbH Leipzig Sachsen
Germany Universität zu Lübeck - Institut für Endokrinologie und Diabetes Lübeck
Germany SMO.MD GmbH Magdeburg Sachsen-Anhalt
Germany CDG Studienambulanz Hartard München Bayern
Germany Institut für Diabetesforschung GmbH Münster Münster Nordrhein-
Germany RED-Institut GmbH Oldenburg Schleswig-Holstein
Germany Private Practice - Dr. Christine Kosch Pirna Sachsen
Germany Diabetologische Schwerpunktpraxis Marck Linn Pickel Pohlheim Hessen
Germany Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf Wallerfing Bayern
Greece Athens Medical Center Athens Attikí
Greece University General Hospital of Larissa Larissa
Greece 424 Military General Training Hospital Thessaloniki
Greece Euromedica General Clinic of Thessaloniki Thessaloniki Thessaloníki
Greece Ippokrateio General Hospital of Thessaloniki Thessaloniki Kentrikí Makedonía
Greece Papageorgiou General Hospital of Thessaloniki Thessaloniki Thessaloníki
Greece Thermi Clinic Thessaloniki Thessaloníki
India Shree Krishna Hospital Anand Gujarat
India Medstar Speciality Hospital Bangalore Karnataka
India Karnataka Institute of Medical Sciences Hubli Karnataka
India Kumudini Devi Diabetes Research Center Hyderabad Telangana
India TOTALL Diabetes Hormone Institute Indore Madhya Pradesh
India Arthur Asirvatham Hospital Madurai Tamil Nadu
India BSES MG Hospital Mumbai Maharashtra
India Topiwala National Medical College & B. Y. L. Nair Charitable Hospital Mumbai Maharashtra
India All India Institute of Medical Sciences (AIIMS) - Nagpur Nagpur Maharashtra
India Dr B. L. Kapur Memorial Hospital New Delhi Delhi
India Sahyadri Super Speciality Hospital Pune Maharashtra
India All India Institute of Medical Sciences Raipur Chhattisgarh
Korea, Republic of Yeungnam Univeristy Medical Center Gyeongsan-si Kyongsangbuk-do
Korea, Republic of Seoul National University Bundang Hospital Seongnam Kyonggi-do
Korea, Republic of Korea University Anam Hospital Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Kyung Hee University Hospital at Gangdong Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of The Catholic Univ. of Korea Seoul St. Mary's Hospital Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Yonsei University-Wonju Severance Christian Hospital Wonju Kang-won-do
Puerto Rico Advanced Clinical Research, LLC Bayamón
Puerto Rico Private Practice - Dr. Paola Mansilla-Letelier Guaynabo
United States Albany Medical College, Division of Community Endocrinology Albany New York
United States Albany Stratton VA Medical Center Albany New York
United States Albuquerque Neuroscience Inc. Albuquerque New Mexico
United States MedStar Good Samaritan Hospital Baltimore Maryland
United States Charlottesville Medical Research Charlottesville Virginia
United States Dallas Diabetes Research Center Dallas Texas
United States Soma Clinical Trials Denison Texas
United States Epic Medical Research - DeSoto DeSoto Texas
United States AMCR Institute Escondido California
United States Encore Medical Research Hollywood Florida
United States Pacific Diabetes & Endocrine Center Honolulu Hawaii
United States National Research Institute - Huntington Park Huntington Park California
United States East Coast Institute for Research, LLC Jacksonville Florida
United States Alliance for Multispecialty Research, LLC Knoxville Tennessee
United States Las Vegas Medical Research Las Vegas Nevada
United States Balanced Life Health Care Solutions/SKYCRNG Lawrenceville Georgia
United States NYC Research INC Long Island City New York
United States National Research Institute - Wilshire Los Angeles California
United States South Florida Clinical Research Institute Margate Florida
United States Solaris Clinical Research Meridian Idaho
United States Catalina Research Institute, LLC Montclair California
United States Cahaba Research - Pelham Pelham Alabama
United States Summit Headlands Portland Oregon
United States Accellacare - Raleigh Raleigh North Carolina
United States Endocrine Research Solutions, Inc. Roswell Georgia
United States StudyMetrix Research Saint Peters Missouri
United States Diabetes and Glandular Disease Center San Antonio Texas
United States VIP Trials San Antonio Texas
United States Universal Research Group Tacoma Washington
United States Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan
United States Novak Clinical Research - Tucson - North La Cholla Boulevard Tucson Arizona
United States University Clinical Investigators, Inc. Tustin California
United States Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa
United States North Georgia Clinical Research Woodstock Georgia
United States Yuma Clinical Trials Yuma Arizona

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  China,  Czechia,  Germany,  Greece,  India,  Korea, Republic of,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Percent Change from Baseline in Body Weight Baseline, Week 72
Secondary Mean Change from Baseline in Waist Circumference Baseline, Week 72
Secondary Mean Change from Baseline in Hemoglobin A1c (HbA1c) % Baseline, Week 72
Secondary Mean Change from Baseline in Fasting Glucose Baseline, Week 72
Secondary Mean Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 72
Secondary Mean Change from Baseline in Fasting Triglycerides Baseline, Week 72
Secondary Mean Percent Change from Baseline in Fasting non-High-Density Lipoprotein (HDL) Cholesterol Baseline, Week 72
Secondary Mean Percent Change from Baseline in Fasting Insulin Baseline, Week 72
Secondary Mean Change from Baseline in Diastolic Blood Pressure (DBP) Baseline, Week 72
Secondary Mean Change from Baseline in Short Form 36 Version 2 Health Survey Acute Form (SF-36v2) Domain Scores Baseline, Week 72
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