A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes
- Conditions
- OverweightObesityType 2 Diabetes
- Interventions
- Drug: Placebo
- Registration Number
- NCT05872620
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1500
-
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).
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orforglipron Dose 1 Orforglipron Participants will receive orforglipron administered orally. Orforglipron Dose 2 Orforglipron Participants will receive orforglipron administered orally. Orforglipron Dose 3 Orforglipron Participants will receive orforglipron administered orally. Placebo Placebo Participants will receive placebo
- Primary Outcome Measures
Name Time Method Mean Percent Change from Baseline in Body Weight Baseline, Week 72
- Secondary Outcome Measures
Name Time Method Mean Change from Baseline in Waist Circumference Baseline, Week 72 Mean Change from Baseline in Hemoglobin A1c (HbA1c) % Baseline, Week 72 Mean Change from Baseline in Fasting Glucose Baseline, Week 72 Mean Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 72 Mean Change from Baseline in Fasting Triglycerides Baseline, Week 72 Mean Percent Change from Baseline in Fasting non-High-Density Lipoprotein (HDL) Cholesterol Baseline, Week 72 Mean Percent Change from Baseline in Fasting Insulin Baseline, Week 72 Mean Change from Baseline in Diastolic Blood Pressure (DBP) Baseline, Week 72 Mean Change from Baseline in Short Form 36 Version 2 Health Survey Acute Form (SF-36v2) Domain Scores Baseline, Week 72
Trial Locations
- Locations (135)
Advara HeartCare Joondalup
🇦🇺Joondalup, Western Australia, Australia
Cahaba Research - Pelham
🇺🇸Pelham, Alabama, United States
Novak Clinical Research - Tucson - North La Cholla Boulevard
🇺🇸Tucson, Arizona, United States
Yuma Clinical Trials
🇺🇸Yuma, Arizona, United States
AMCR Institute
🇺🇸Escondido, California, United States
Velocity Clinical Research, Huntington Park
🇺🇸Huntington Park, California, United States
Velocity Clinical Research, Westlake
🇺🇸Los Angeles, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Encore Medical Research
🇺🇸Hollywood, Florida, United States
East Coast Institute for Research, LLC
🇺🇸Jacksonville, Florida, United States
South Florida Clinical Research Institute
🇺🇸Margate, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Balanced Life Health Care Solutions/SKYCRNG
🇺🇸Lawrenceville, Georgia, United States
Endocrine Research Solutions, Inc.
🇺🇸Roswell, Georgia, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Pacific Diabetes & Endocrine Center
🇺🇸Honolulu, Hawaii, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
MedStar Good Samaritan Hospital
🇺🇸Baltimore, Maryland, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
🇺🇸Troy, Michigan, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
IMA Clinical Research
🇺🇸Albuquerque, New Mexico, United States
Albany Medical College, Division of Community Endocrinology
🇺🇸Albany, New York, United States
Albany Stratton VA Medical Center
🇺🇸Albany, New York, United States
NYC Research INC
🇺🇸Long Island City, New York, United States
Accellacare - Raleigh
🇺🇸Raleigh, North Carolina, United States
Summit Headlands
🇺🇸Portland, Oregon, United States
Alliance for Multispecialty Research, LLC
🇺🇸Knoxville, Tennessee, United States
Velocity Clinical Research, Dallas
🇺🇸Dallas, Texas, United States
Soma Clinical Trials
🇺🇸Denison, Texas, United States
Epic Medical Research - DeSoto
🇺🇸DeSoto, Texas, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Diabetes and Glandular Disease Center
🇺🇸San Antonio, Texas, United States
VIP Trials
🇺🇸San Antonio, Texas, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Universal Research Group
🇺🇸Tacoma, Washington, United States
CEMEDIAB
🇦🇷C.a.b.a., Ciudad Aut, Argentina
Mautalen Salud e Investigación
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Instituto Centenario
🇦🇷Caba, Ciudad Autónoma De Buenos Aire, Argentina
Instituto de Investigaciones Clinicas Rosario
🇦🇷Rosario, Santa Fe, Argentina
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
🇦🇷Rosario, Santa Fe, Argentina
Sanatorio San Martin
🇦🇷Venado Tuerto, Santa Fe, Argentina
Centro de Investigaciones Médicas Tucuman
🇦🇷SAN M. DE Tucuman, Tucumán, Argentina
CONEXA Investigacion Clinica S.A.
🇦🇷Buenos Aires, Argentina
Centro Diabetológico Dr. Waitman
🇦🇷Córdoba, Argentina
Clínica Universitaria Reina Fabiola
🇦🇷Córdoba, Argentina
Centro de Diagnóstico y Rehabilitación (CEDIR)
🇦🇷Santa Fe, Argentina
Emeritus Research
🇦🇺Camberwell, Victoria, Australia
The AIM Centre / Hunter Diabetes Centre
🇦🇺Merewether, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Core Research Group
🇦🇺Brisbane, Queensland, Australia
Logan Hospital
🇦🇺Meadowbrook, Queensland, Australia
Southern Adelaide Diabetes & Endocrine Services
🇦🇺Oaklands Park, South Australia, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Austin Health - Repatriation Hospital
🇦🇺Heidelberg West, Victoria, Australia
Baker IDI Heart and Diabetes Institute - Melbourne
🇦🇺Melbourne, Victoria, Australia
Centro de Pesquisa Clinica do Brasil
🇧🇷Brasilia, Distrito Federal, Brazil
Cendi - Endocrinologia e Diabetes
🇧🇷Goiânia, Goiás, Brazil
Instituto Lóbus
🇧🇷Volta Redonda, Rio De Janeiro, Brazil
Instituto Méderi de Pesquisa e Saúde
🇧🇷Passo Fundo, Rio Grande Do Sul, Brazil
Instituto de Pesquisa clinica de Campinas
🇧🇷Campinas, São Paulo, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIM
🇧🇷Marília, São Paulo, Brazil
Pesquisare Saude
🇧🇷Santo André, São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica
🇧🇷São Paulo, Brazil
The Second People's Hospital of Hefei
🇨🇳Hefei, Anhui, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Chongqing General Hospital
🇨🇳Chongqing, Chongqing, China
ShenZhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
🇨🇳Luoyang Shi, Henan, China
The Second Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Jiangsu Province Official Hospital
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Nantong First People's Hospital
🇨🇳Nantong, Jiangsu, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University Zhu Xianyi Memorial Hospital
🇨🇳Tianjin, Tianjin, China
The First People's Hospital of Yunnan Province
🇨🇳Kunming, Yunnan, China
MUDr. Alena Vachova
🇨🇿Ceske Budejovice, Jihočeský, Czechia
MUDr. Tomas Edelsberger
🇨🇿Krnov, Moravskosl, Czechia
Diahelp s.r.o
🇨🇿Pardubice V, Pardubice, Czechia
Dialine - Interni a diabetologicka ambulance
🇨🇿Pilsen, Plzeň-město, 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
MUDr. Sabina Palova
🇨🇿Jilove u Prahy, Praha-západ, Czechia
Milan Kvapil s.r.o., Diabetologicka ambulance Pribram
🇨🇿Pribram, Středočeský Kraj, Czechia
Endokrinologie MUDr. Rehorkova s.r.o.
🇨🇿Hradec Kralove, Czechia
MUDr. Jitka Zemanová - diabetologie a interna s.r.o.
🇨🇿Plzen, Czechia
Nemocnice Cesky Krumlov
🇨🇿Český Krumlov, Czechia
CDG Studienambulanz Hartard
🇩🇪München, Bayern, Germany
Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf
🇩🇪Wallerfing, Bayern, Germany
Ceda-Research
🇩🇪Pohlheim, Hessen, Germany
InnoDiab Forschung Gmbh
🇩🇪Essen, Nordrhein-Westfalen, Germany
Medizentrum Essen Borbeck
🇩🇪Essen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Koeln
🇩🇪Köln, Nordrhein-Westfalen, Germany
Institut für Diabetesforschung GmbH Münster
🇩🇪Münster, Nordrhein-, Germany
Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels
🇩🇪Hohenmölsen, Sachsen-Anhalt, Germany
SMO.MD GmbH
🇩🇪Magdeburg, Sachsen-Anhalt, Germany
AmBeNet GmbH
🇩🇪Leipzig, Sachsen, Germany
Arztpraxis Christine Kosch Pirna
🇩🇪Pirna, Sachsen, Germany
Universität zu Lübeck - Institut für Endokrinologie und Diabetes
🇩🇪Lübeck, Schleswig-Holstein, Germany
RED-Institut GmbH
🇩🇪Oldenburg, Schleswig-Holstein, Germany
Diabetes Zentrum Dr. Tews
🇩🇪Gelnhausen, Germany
Diabetes Zentrum Wilhelmsburg
🇩🇪Hamburg, Germany
Athens Medical Center
🇬🇷Athens, Attikí, Greece
Ippokrateio General Hospital of Thessaloniki
🇬🇷Thessaloniki, Kentrikí Makedonía, Greece
Euromedica General Clinic of Thessaloniki
🇬🇷Thessaloniki, Thessaloníki, Greece
Papageorgiou General Hospital of Thessaloniki
🇬🇷Thessaloniki, Thessaloníki, Greece
Thermi Clinic
🇬🇷Thessaloniki, Thessaloníki, Greece
University General Hospital of Larissa
🇬🇷Larissa, Thessalía, Greece
424 Military General Training Hospital
🇬🇷Thessaloniki, Greece
Medstar Speciality Hospital
🇮🇳Bangalore, Karnataka, India
Karnataka Institute of Medical Sciences
🇮🇳Hubli, Karnataka, India
TOTALL Diabetes Hormone Institute
🇮🇳Indore, Madhya Pradesh, India
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
🇮🇳Mumbai, Maharashtra, India
BSES MG Hospital
🇮🇳Mumbai, Maharashtra, India
All India Institute of Medical Sciences (AIIMS) - Nagpur
🇮🇳Nagpur, Maharashtra, India
Sahyadri Super Speciality Hospital
🇮🇳Pune, Maharashtra, India
Arthur Asirvatham Hospital
🇮🇳Madurai, Tamil Nadu, India
Kumudini Devi Diabetes Research Center
🇮🇳Hyderabad, Telangana, India
Yonsei University-Wonju Severance Christian Hospital
🇰🇷Wonju, Kang-won-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Kyǒnggi-do, Korea, Republic of
Yeungnam Univeristy Medical Center
🇰🇷Gyeongsan-si, Kyǒngsangbuk-do, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
The Catholic Univ. of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Advanced Clinical Research, LLC
🇵🇷Bayamón, Puerto Rico
Isis Clinical Research Center
🇵🇷Guaynabo, Puerto Rico