A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Type 2 Diabetes
- Conditions
- ObesityOverweightType 2 Diabetes
- Interventions
- Drug: Placebo
- Registration Number
- NCT06972472
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to see how orforglipron, compared with placebo, helps improve glycemic control in participants with obesity or with overweight and type 2 diabetes. This trial is part of the master protocol study J2A-MC-GZPO.
Participation in the study will last about 18 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 600
- Have body mass index (BMI) ≥25 kilograms per square meter (kg/m2) at screening
- Have type 2 diabetes
- Have hemoglobin A1c (HbA1c) ≥7% and ≤10% at screening
- Have a history of at least one unsuccessful dietary effort to lose body weight
- Have type 1 diabetes
- Have an unstable body weight within 90 days prior to screening
- Have New York Heart Association functional classification IV congestive heart failure or an acute cardiovascular condition within 90 days prior to screening
- Have acute or chronic hepatitis or pancreatitis
- Are taking other medications or alternative remedies to manage weight loss
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orforglipron Dose 1 Orforglipron Participants will receive orforglipron orally Orforglipron Dose 2 Orforglipron Participants will receive orforglipron orally Orforglipron Dose 3 Orforglipron Participants will receive orforglipron orally Orforglipron Dose 4 Orforglipron Participants will receive orforglipron orally Placebo Placebo Participants will receive placebo orally
- Primary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 40
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline up to 72 weeks Change from Baseline in HbA1c at Week 72 Baseline, Week 72 Change from Baseline in Fasting Glucose Baseline up to 72 weeks Percentage of Participants Achieving HbA1c of <7.0% Baseline up to 72 weeks Percentage of Participants Achieving Weight Reduction of ≥5% Baseline up to 72 weeks Change from Baseline in Waist Circumference Baseline up to 72 weeks Change from Baseline in Body Max Index (BMI) Baseline, Week 72 Change from Baseline in Systolic Blood Pressure (SBP) Baseline up to 72 weeks Percent Change from Baseline in Triglycerides Baseline up to 72 weeks Change from Baseline in EQ-5D-5L Baseline, Week 72 Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Orforglipron Predose through Week 48
Trial Locations
- Locations (89)
Southern California Clinical Research
🇺🇸Santa Ana, California, United States
Novak Clinical Research - Tucson - North La Cholla Boulevard
🇺🇸Tucson, Arizona, United States
Norcal Endocrinology & Internal Medicine
🇺🇸San Ramon, California, United States
Care Access - Thousand Oaks
🇺🇸Thousand Oaks, California, United States
Accel Research Sites - DeLand Clinical Research Unit
🇺🇸DeLand, Florida, United States
Innovation Medical Research Center - Fort Lauderdale
🇺🇸Fort Lauderdale, Florida, United States
Encore Medical Research
🇺🇸Hollywood, Florida, United States
West Orange Endocrinology P.A.
🇺🇸Ocoee, Florida, United States
Care Access - Tampa
🇺🇸Tampa, Florida, United States
Care Access - Decatur
🇺🇸Decatur, Georgia, United States
Accel Research Sites - NeuroStudies Clinical Research Unit
🇺🇸Decatur, Georgia, United States
Javara - Privia Medical Group Georgia - Savannah
🇺🇸Savannah, Georgia, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
Care Access - New Iberia
🇺🇸New Iberia, Louisiana, United States
Endocrine and Metabolic Consultants
🇺🇸Rockville, Maryland, United States
Javara - Privia Medical Group - Silver Spring
🇺🇸Silver Spring, Maryland, United States
Boeson Research MSO
🇺🇸Missoula, Montana, United States
Javara - Nevada Health Centers - Carson City
🇺🇸Carson City, Nevada, United States
The Machuca Foundation
🇺🇸Las Vegas, Nevada, United States
University of North Carolina Medical Center
🇺🇸Chapel Hill, North Carolina, United States
Javara - Tryon Medical Partners
🇺🇸Charlotte, North Carolina, United States
Care Access - Fayetteville
🇺🇸Fayetteville, North Carolina, United States
The Corvallis Clinic, P.C.
🇺🇸Corvallis, Oregon, United States
CARE - Centro de Alergia y Enfermedades Respiratorias
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Centro Médico Viamonte
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Clinical Research of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Frontier Clinical Research, LLC
🇺🇸Smithfield, Pennsylvania, United States
Velocity Clinical Research, Dallas
🇺🇸Dallas, Texas, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Zhujiang Hospital
🇨🇳Guangzhou, Guangdong, China
Texas Valley Clinical Research (TVCR) - Mission
🇺🇸Mission, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
CIPREC
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Instituto Centenario
🇦🇷Caba, Ciudad Autónoma De Buenos Aires, Argentina
Instituto Médico Catamarca IMEC
🇦🇷Rosario, Santa Fe, Argentina
Centro de Diagnóstico y Rehabilitación (CEDIR)
🇦🇷Santa Fe, Argentina
The Second People's Hospital of Hefei
🇨🇳Hefei, Anhui, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Xuanwu Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Henan University of Science &Technology
🇨🇳Luoyang Shi, Henan, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
The Second Hospital of Tianjin Medical University
🇨🇳Tianjin, Tianjin, China
MUDr. Alena Vachova
🇨🇿Ceske Budejovice, Jihočeský Kraj, Czechia
VASOMED Clinic
🇨🇿Ostrava, Moravskoslezský Kraj, Czechia
Milan Kvapil s.r.o., Diabetologicka ambulance
🇨🇿Praha, Praha 4, Czechia
Medical Plus
🇨🇿Uherske Hradiste, Zlínský Kraj, Czechia
Nemocnice Cesky Krumlov
🇨🇿Český Krumlov, Czechia
Medicover Neuroendokrinologie
🇩🇪Munich, Bayern, Germany
InnoDiab Forschung Gmbh
🇩🇪Essen, Nordrhein-Westfalen, Germany
Medizentrum Essen Borbeck
🇩🇪Essen, Nordrhein-Westfalen, Germany
AmBeNet GmbH
🇩🇪Leipzig, Sachsen, Germany
Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
🇩🇪Leipzig, Sachsen, Germany
RED-Institut GmbH
🇩🇪Oldenburg, Schleswig-Holstein, Germany
Diabetes Zentrum Wilhelmsburg
🇩🇪Hamburg, Germany
Apollo Excelcare Hospital
🇮🇳Guwahati, Assam, India
Sir Ganga Ram Hospital
🇮🇳New Delhi, Delhi, India
Karnataka Institute of Medical Sciences
🇮🇳Hubli, Karnataka, India
Chellaram Diabetes Institute
🇮🇳Pune, Maharashtra, India
All India Institute of Medical Sciences
🇮🇳Bhubaneswar, Odisha, India
Diabetes Research Center
🇮🇳Hyderabad, Telangana, India
All India Institute of Medical Sciences - Rishikesh
🇮🇳Rishikesh, Uttarakhand, India
Tokuyama Clinic
🇯🇵Mihama-ku,Chiba City, Chiba, Japan
Hasegawa Medical Clinic
🇯🇵Chitose, Hokkaido, Japan
Tsuchiura Medical & Health Care Center
🇯🇵Tsuchiura, Ibaraki, Japan
Noritake Clinic
🇯🇵Ushiku, Ibaraki, Japan
Olive Takamatsu Medical Clinic
🇯🇵Takamatsu, Kagawa, Japan
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
🇯🇵Yamato-shi, Kanagawa, Japan
Yokohama Minoru Clinic
🇯🇵Yokohama, Kanagawa, Japan
Medical Corporation Heishinkai OCROM Clinic
🇯🇵Suita-shi, Osaka, Japan
The Institute of Medical Science, Asahi Life Foundation
🇯🇵Chuo-ku, Tokyo, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Fukuwa Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Medical Corporation Heishinkai ToCROM Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan
Shimokitazawa Tomo Clinic
🇯🇵Tokyo, Japan
RM Pharma Specialists - Unidad Especializada en Datos
🇲🇽Mexico City, Distrito Federal, Mexico
Endocrinologia Especializada
🇲🇽Mexico, Distrito Federal, Mexico
Diseno y Planeacion en Investigacion Medica - Guadalajara - Calle Amado Nervo
🇲🇽Guadalajara, Jalisco, Mexico
Centro Medico Zambrano Hellion
🇲🇽San Pedro Garza Garcia, Nuevo León, Mexico
Medical Care and Research SA de CV
🇲🇽Merida, Yucatán, Mexico
Kohler & Milstein Research S.A. De C.V.
🇲🇽Mérida, Yucatán, Mexico
Enclifar Ensayos Clínicos Farmacológicos Sc
🇲🇽Chihuahua, Mexico
Puerto Rico Health and Wellness Institute
🇵🇷Dorado, Puerto Rico
Isis Clinical Research Center
🇵🇷Guaynabo, Puerto Rico