A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
- Conditions
- ObesityOverweightOverweight or Obesity
- Interventions
- Drug: Placebo
- Registration Number
- NCT05869903
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 3000
-
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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will be given placebo. Orforglipron Dose 1 Orforglipron Participant will receive orforglipron administered orally. Orforglipron Dose 2 Orforglipron Participant will receive orforglipron administered orally. Orforglipron Dose 3 Orforglipron Participant will receive orforglipron administered orally.
- Primary Outcome Measures
Name Time Method Mean Percent Change from Baseline in Body Weight Baseline to Week 72
- Secondary Outcome Measures
Name Time Method Mean Change from Baseline in Waist Circumference Baseline, Week 72 Mean Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 72 Mean Percent Change from Baseline in Fasting non-HDL Cholesterol Baseline, Week 72 Mean Percent Change from Baseline in Fasting Triglycerides 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 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 Version 2 (SF-36v2) Acute Form Domain Scores Baseline, Week 72
Trial Locations
- Locations (138)
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
🇺🇸Chandler, Arizona, United States
Velocity Clinical Research, Huntington Park
🇺🇸Huntington Park, California, United States
Velocity Clinical Research, Westlake
🇺🇸Los Angeles, California, United States
East Coast Institute for Research, LLC
🇺🇸Macon, Georgia, United States
Cotton O'Neil Diabetes & Endocrinology
🇺🇸Topeka, Kansas, United States
SKY Integrative Medical Center/SKYCRNG
🇺🇸Ridgeland, Mississippi, United States
Alliance for Multispecialty Research, LLC
🇺🇸Norman, Oklahoma, United States
Velocity Clinical Research, Dallas
🇺🇸Dallas, Texas, United States
Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas
🇧🇷Fortaleza, Ceará, Brazil
Quanta Diagnóstico e Terapia
🇧🇷Curitiba, Paraná, Brazil
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Osaka Nishiumeda Clinic
🇯🇵Osaka, Japan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Clinical Research Institute of Arizona (CRI) - Sun City West
🇺🇸Sun City West, Arizona, United States
John Muir Physician Network Research Center
🇺🇸Concord, California, United States
AMCR Institute
🇺🇸Escondido, California, United States
NorCal Medical Research, Inc
🇺🇸Greenbrae, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Norcal Endocrinology & Internal Medicine
🇺🇸San Ramon, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
New Age Medical Research Corporation
🇺🇸Miami, Florida, United States
South Broward Research
🇺🇸Miramar, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Jedidiah Clinical Research - Tampa - Bay Plaza
🇺🇸Tampa, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
🇺🇸Winter Park, Florida, United States
Physicians Research Associates
🇺🇸Lawrenceville, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
🇺🇸Union City, Georgia, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Elite Clinical Trials
🇺🇸Blackfoot, Idaho, United States
Cotton O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States
Care Access - Lake Charles
🇺🇸Lake Charles, Louisiana, United States
MedStar Health Research Institute (MedStar Physician Based Research Network)
🇺🇸Hyattsville, Maryland, United States
Endocrine and Metabolic Consultants
🇺🇸Rockville, Maryland, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
🇺🇸Troy, Michigan, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
Long Island Cardiovascular Consultants
🇺🇸Lake Success, New York, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Texas Diabetes & Endocrinology, P.A.
🇺🇸Austin, Texas, United States
Thyroid, Endocrinology, and Diabetes
🇺🇸Dallas, Texas, United States
Cedar Health Research
🇺🇸Dallas, Texas, United States
Juno Research
🇺🇸Houston, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Soma Clinical Trials
🇺🇸Wylie, Texas, United States
Physicians' Research Options
🇺🇸Draper, Utah, United States
Health Research of Hampton Roads, Inc.
🇺🇸Newport News, Virginia, United States
Eastside Research Associates
🇺🇸Redmond, Washington, United States
CEDOES
🇧🇷Vitória, Espírito Santo, Brazil
Hospital São Domingos
🇧🇷Bequimao, Maranhão, Brazil
Cline Research Center
🇧🇷Curitiba, Paraná, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Centro de Pesquisa Sao Lucas
🇧🇷Campinas, São Paulo, Brazil
CECIP - Centro de Estudos do Interior Paulista
🇧🇷Jaú, São Paulo, Brazil
Centro Multidisciplinar de Estudos Clinicos
🇧🇷Sao Bernardo do Campo, São Paulo, Brazil
Integral Pesquisa e Ensino
🇧🇷Votuporanga, São Paulo, Brazil
Hospital São Lucas de Copacabana
🇧🇷Rio de Janeiro, Brazil
CPQuali Pesquisa Clínica
🇧🇷São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica
🇧🇷São Paulo, Brazil
Hospital das Clinicas FMUSP
🇧🇷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
Hainan General Hospital
🇨🇳Haikou, Hainan, 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
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Jiading District Central Hospital
🇨🇳Shanghai, Shanghai, 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
Zhejiang Hospital
🇨🇳Hangzhou, Zhejiang, China
Ningbo First Hospital
🇨🇳Ningbo, Zhejiang, China
Endolife Speciality Hospitals
🇮🇳Guntur, Andhra Pradesh, India
Victoria Hospital, Bangalore Medical College And Research Institute
🇮🇳Bangalore, Karnataka, India
Mysore Medical College
🇮🇳Mysore, Karnataka, India
Central India Cardiology and Research Institute
🇮🇳Nagpur, Maharashtra, India
All India Institute of Medical Sciences (AIIMS) - Nagpur
🇮🇳Nagpur, Maharashtra, India
Deenanath Mangeshkar Hospital & Research Centre
🇮🇳Pune, Maharashtra, India
Sahyadri Super Speciality Hospital
🇮🇳Pune, Maharashtra, India
Lifepoint Multispeciality Hospital
🇮🇳Pune, Maharashtra, India
Oishi Clinic
🇯🇵Kasuya, Fukuoka, Japan
Mazda Hospital
🇯🇵Aki-gun, Hiroshima, Japan
Tsuchiura Medical & Health Care Center
🇯🇵Tsuchiura, Ibaraki, Japan
NTT Nishinihon Takamatsu Clinic
🇯🇵Takamatsu, Kagawa, Japan
Iwamoto Internal Medicine Clinic
🇯🇵Zentsuji, Kagawa, Japan
Yokohama Minoru Clinic
🇯🇵Yokohama, Kanagawa, Japan
Medical Corporation Heishinkai OCROM Clinic
🇯🇵Suita-shi, Osaka, Japan
Sugiura Internal Medicine Clinic
🇯🇵Soka, Saitama, Japan
Adachi Kyosai Hospital
🇯🇵Adachi-ku, Tokyo, Japan
Medical Corporation Chiseikai Tokyo Center Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Fukuwa Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Yutenji Medical Clinic
🇯🇵Meguro-ku, Tokyo, Japan
Kanno Naika
🇯🇵Mitaka, Tokyo, Japan
Shimokitazawa Tomo Clinic
🇯🇵Setagaya-ku, Tokyo, Japan
Heishinkai Medical Group ToCROM Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan
Boocs Clinic Fukuoka
🇯🇵Fukuoka, Japan
Gachon University Gil Medical Center
🇰🇷Namdong-gu, Incheon-gw, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan-si, Kyǒnggi-do, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang-si, Kyǒnggi-do, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Kyǒnggi-do, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Busan, Kyǒngsangnam-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Konyang University Hospital
🇰🇷Seo-gu, Taejǒn-Kwangyǒkshi, Korea, Republic of
Dorado Medical Complex
🇵🇷Dorado, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
🇵🇷San Juan, Puerto Rico
Nemocnica s poliklinikou Lucenec
🇸🇰Lucenec, Banskobystrický Kraj, Slovakia
Metabol KLINIK
🇸🇰Bratislava, Bratislavský Kraj, Slovakia
Human Care s.r.o.
🇸🇰Kosice, Košický Kraj, Slovakia
Areteus s.r.o.
🇸🇰Trebisov, Košický Kraj, Slovakia
DIAB sro
🇸🇰Roznava, Košický Kr, Slovakia
MEDI-DIA s.r.o.
🇸🇰Sabinov, Prešovský Kraj, Slovakia
DIA-MED CENTRUM s.r.o.
🇸🇰Puchov, Trenčiansky Kraj, Slovakia
MediTask
🇸🇰Bratislava, Slovakia
CHUAC-Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, A Coruña [La Coruña], Spain
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
🇪🇸Ferrol, A Coruña [La Coruña], Spain
Centro Periférico de Especialidades Bola Azul
🇪🇸Almeria, Almería, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Andalucía, Spain
Hospital Quiron Infanta Luisa
🇪🇸Sevilla, Andalucía, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Barcelona [Barcelona], Spain
Centro Médico Teknon
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Castilla Y León, Spain
Hospital Virgen del Camino
🇪🇸Sanlúcar de Barrameda, Cádiz, Spain
Hospital Virgen de las Montañas
🇪🇸Villamartin, Cádiz, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Valenciana, Comunitat, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸València, Spain
Chiayi Christian Hospital
🇨🇳Chiayi City, Chiayi, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
🇨🇳Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Changhua Christian Hospital
🇨🇳Changhua, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan