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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05869903
Other study ID # 18559
Secondary ID J2A-MC-GZGP2022-
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date June 5, 2023
Est. completion date September 24, 2027

Study information

Verified date May 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 efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3000
Est. completion date September 24, 2027
Est. primary completion date September 12, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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


Related Conditions & MeSH terms


Intervention

Drug:
Orforglipron
Administered orally.
Placebo
Administered orally.

Locations

Country Name City State
Brazil Hospital São Domingos Bequimao Maranhão
Brazil Centro de Pesquisa Sao Lucas Campinas São Paulo
Brazil Cline Research Center Curitiba Paraná
Brazil Pesquisa Clínica em Diabetes - Dra Rosângela Réa Curitiba Paraná
Brazil Private Practice - Dr.Miguel N. Hissa Fortaleza Ceará
Brazil CECIP - Centro de Estudos do Interior Paulista Jaú São Paulo
Brazil Núcleo de Pesquisa Clínica do Rio Grande do Sul Porto Alegre Rio Grande Do Sul
Brazil Hospital São Lucas de Copacabana Rio de Janeiro
Brazil Centro Multidisciplinar de Estudos Clinicos Sao Bernardo do Campo São Paulo
Brazil CEPIC - Centro Paulista de Investigação Clínica São Paulo
Brazil CPQuali Pesquisa Clínica São Paulo
Brazil Hospital das Clinicas FMUSP São Paulo
Brazil CEDOES Vitória Espírito Santo
Brazil Integral Pesquisa e Ensino Votuporanga São Paulo
China Chinese PLA General Hospital Beijing Beijing
China Chongqing General Hospital Chongqing Chongqing
China Hainan General Hospital Haikou Hainan
China Zhejiang Hospital Hangzhou Zhejiang
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 Nanjing First Hospital Nanjing Jiangsu
China The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
China Ningbo First Hospital Ningbo Zhejiang
China Jiading District Central Hospital Shanghai Shanghai
China ShenZhen People's Hospital Shenzhen Guangdong
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu
China Tianjin Medical University General Hospital Tianjin Tianjin
China Tianjin Medical University Zhu Xianyi Memorial Hospital Tianjin Tianjin
China The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan
China Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu
India Victoria Hospital, Bangalore Medical College And Research Institute Bangalore Karnataka
India Endolife Speciality Hospitals Guntur Andhra Pradesh
India Mysore Medical College Mysore Karnataka
India All India Institute of Medical Sciences (AIIMS) - Nagpur Nagpur Maharashtra
India Central India Cardiology and Research Institute Nagpur Maharashtra
India Deenanath Mangeshkar Hospital & Research Centre Pune Maharashtra
India Lifepoint Multispeciality Hospital Pune Maharashtra
India Sahyadri Super Speciality Hospital Pune Maharashtra
Japan Adachi Kyosai Hospital Adachi-ku Tokyo
Japan Mazda Hospital Aki-gun Hiroshima
Japan Fukuwa Clinic Chuo-ku Tokyo
Japan Medical Corporation Chiseikai Tokyo Center Clinic Chuo-ku Tokyo
Japan Tokyo-Eki Center-building Clinic Chuo-ku Tokyo
Japan Boocs Clinic Fukuoka Fukuoka
Japan Oishi Clinic Kasuya Fukuoka
Japan Yutenji Medical Clinic Meguro-ku Tokyo
Japan Kanno Naika Mitaka Tokyo
Japan AMC Nishiumeda Clinic Osaka
Japan Shimokitazawa Tomo Clinic Setagaya-ku Tokyo
Japan Heishinkai Medical Group ToCROM Clinic Shinjuku-ku Tokyo
Japan Sugiura Internal Medicine Clinic Soka Saitama
Japan Medical Corporation Heishinkai OCROM Clinic Suita-shi Osaka
Japan NTT Nishinihon Takamatsu Clinic Takamatsu Kagawa
Japan Tsuchiura Medical & Health Care Center Tsuchiura Ibaraki
Japan Yokohama Minoru Clinic Yokohama Kanagawa
Japan Iwamoto Internal Medicine Clinic Zentsuji Kagawa
Korea, Republic of Korea University Ansan Hospital Ansan-si Kyonggi-do
Korea, Republic of Hallym University Sacred Heart Hospital Anyang-si Kyonggi-do
Korea, Republic of Pusan National University Yangsan Hospital Busan Kyongsangnam-do
Korea, Republic of Gachon University Gil Medical Center Namdong-gu Incheon-gw
Korea, Republic of Konyang University Hospital Seo-gu Taejon-Kwangyokshi
Korea, Republic of Seoul National University Hospital Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Ajou University Hospital Suwon Kyonggi-do
Puerto Rico Dorado Medical Complex Dorado
Puerto Rico GCM Medical Group, PSC - Hato Rey Site San Juan
Slovakia MediTask Bratislava
Slovakia Metabol KLINIK Bratislava Bratislavský Kraj
Slovakia Human Care s.r.o. Kosice Košický Kraj
Slovakia Nemocnica s poliklinikou Lucenec Lucenec Banskobystrický Kraj
Slovakia DIA-MED CENTRUM s.r.o. Puchov Trenciansky Kraj
Slovakia DIAB sro Roznava Košický Kr
Slovakia MEDI-DIA s.r.o. Sabinov Prešovský Kraj
Slovakia Areteus s.r.o. Trebisov Košický Kraj
Spain CHUAC-Complejo Hospitalario Universitario A Coruña A Coruña A Coruña [La Coruña]
Spain Centro Periférico de Especialidades Bola Azul Almeria Almería
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 Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval Ferrol A Coruña [La Coruña]
Spain Hospital Universitario Virgen de la Victoria Malaga Andalucía
Spain Hospital Virgen del Camino Sanlúcar de Barrameda Cádiz
Spain Hospital Quiron Infanta Luisa Sevilla Andalucía
Spain Hospital General Universitario de Valencia Valencia Valenciana, Comunitat
Spain Hospital Universitari i Politecnic La Fe València
Spain Hospital Clínico Universitario de Valladolid Valladolid Castilla Y León
Spain Hospital Virgen de las Montañas Villamartin Cádiz
Taiwan Changhua Christian Hospital Changhua
Taiwan Chiayi Christian Hospital Chiayi City Chiayi
Taiwan Kaohsiung Medical University Hospital Kaohsiung
Taiwan Chang Gung Memorial Hospital at Kaohsiung Kaohsiung Niao Sung Dist Kaohsiung
Taiwan National Cheng Kung University Hospital Tainan
United States University of Colorado Anschutz Medical Campus Aurora Colorado
United States Texas Diabetes & Endocrinology, P.A. Austin Texas
United States Pennington Biomedical Research Center Baton Rouge Louisiana
United States Elite Clinical Trials Blackfoot Idaho
United States John Muir Physician Network Research Center Concord California
United States Cedar Health Research Dallas Texas
United States Dallas Diabetes Research Center Dallas Texas
United States Thyroid, Endocrinology, and Diabetes Dallas Texas
United States Physicians' Research Options Draper Utah
United States AMCR Institute Escondido California
United States NorCal Medical Research, Inc Greenbrae California
United States East-West Medical Research Institute Honolulu Hawaii
United States Juno Research Houston Texas
United States National Research Institute - Huntington Park Huntington Park California
United States MedStar Health Research Institute (MedStar Physician Based Research Network) Hyattsville Maryland
United States Care Access - Lake Charles Lake Charles Louisiana
United States Long Island Cardiovascular Consultants Lake Success New York
United States Las Vegas Medical Research Las Vegas Nevada
United States Physicians Research Associates Lawrenceville Georgia
United States National Research Institute - Wilshire Los Angeles California
United States East Coast Institute for Research at The Jones Center Macon Georgia
United States The Institute for Liver Health dba Arizona Clinical Trials Mesa Arizona
United States New Age Medical Research Corporation Miami Florida
United States South Broward Research Miramar Florida
United States Catalina Research Institute, LLC Montclair California
United States Weill Cornell Medical College New York New York
United States Health Research of Hampton Roads, Inc. Newport News Virginia
United States Intend Research, LLC Norman Oklahoma
United States Renstar Medical Research Ocala Florida
United States Eastside Research Associates Redmond Washington
United States SKY Clinical Research Network Group-Quinn Ridgeland Mississippi
United States Endocrine and Metabolic Consultants Rockville Maryland
United States Norcal Endocrinology & Internal Medicine San Ramon California
United States Consano Clinical Research, LLC Shavano Park Texas
United States Clinical Research Institute of Arizona (CRI) - Sun City West Sun City West Arizona
United States Jedidiah Clinical Research - Tampa - Bay Plaza Tampa Florida
United States Cotton O'Neil Clinical Research Center Topeka Kansas
United States Cotton O'Neil Clinical Research Center - Central Office Topeka Kansas
United States Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan
United States University Clinical Investigators, Inc. Tustin California
United States Rophe Adult and Pediatric Medicine/SKYCRNG Union City Georgia
United States Clinical Site Partners, LLC dba Flourish Research Winter Park Florida
United States Soma Clinical Trials Wylie Texas

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Brazil,  China,  India,  Japan,  Korea, Republic of,  Puerto Rico,  Slovakia,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Percent Change from Baseline in Body Weight Baseline to Week 72
Secondary Mean Change from Baseline in Waist Circumference Baseline, Week 72
Secondary Mean Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 72
Secondary Mean Percent Change from Baseline in Fasting non-HDL Cholesterol Baseline, Week 72
Secondary Mean Percent Change from Baseline in Fasting Triglycerides 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 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 Version 2 (SF-36v2) Acute Form Domain Scores Baseline, Week 72
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