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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05971940
Other study ID # 18564
Secondary ID J2A-MC-GZGTU1111
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date August 9, 2023
Est. completion date April 9, 2025

Study information

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

Clinical Trial Summary

The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 520
Est. completion date April 9, 2025
Est. primary completion date April 9, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have Type 2 Diabetes - Have HbA1c =7.0% (53 mmol/mol) to =9.5% (80 mmol/mol) despite diet and exercise treatment, as determined by the central laboratory at screening. - Are naïve to insulin therapy except for gestational diabetes or =14 days use for acute treatment and have not used any oral or injectable antihyperglycemic medications during the 90 days preceding screening or between screening and randomization. - Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment. - Have a body mass index (BMI) =23.0 kilogram/square meter (kg/m²) at screening. Exclusion Criteria: - Have Type 1 Diabetes - Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization. - Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema - Have New York Heart Association functional classification IV congestive heart failure. - Have acute or chronic pancreatitis

Study Design


Intervention

Drug:
Orforglipron
Administered orally.
Placebo
Administered orally

Locations

Country Name City State
China Beijing Hospital Beijing Beijing
China Beijing Pinggu District Hospital Beijing Beijing
China Luhe Hospital Beijing Beijing
China West China Hospital of Sichuan University Cheng Du Sichuan
China Shunde Hospital of Southern Medical Univesity Foshan Guangdong
China The Fourth Hospital of Harbin Medical University Harbin Heilongjiang
China Huizhou Municipal Central Hospital Huizhou Guangdong
China Jinan Central Hospital Jinan Shandong
China Nanjing First Hospital Nanjing Jiangsu
China The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
China Nanyang First People's Hospital Nanyang Henan
China Pudong New Area People's Hospital Shanghai Shanghai Shanghai
China Wannan Medical College Yijishan Hospital Wuhu Anhui
China The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan
China Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu
India B. J. Medical College & Civil Hospital Ahmedabad Gujarat
India M S Ramaiah Medical College and Hospitals Bangalore Karnataka
India Medstar Speciality Hospital Bangalore Karnataka
India GMERS Medical College and General Hospital Baroda Gujarat
India Madras Diabetes Research Foundation Chennai Tamil Nadu
India Kumudini Devi Diabetes Research Center Hyderabad Telangana
India Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital Kolkata West Bengal
India BSES MG Hospital Mumbai Maharashtra
India All India Institute of Medical Sciences (AIIMS) - Nagpur Nagpur Maharashtra
India Grant Medical Foundation - Ruby Hall Clinic Pune Maharashtra
Japan Hayashi Diabetes Internal Medicine Clinic Chigasaki Kanagawa
Japan Hasegawa Medical Clinic Chitose Hokkaido
Japan Fukuwa Clinic Chuo-ku Tokyo
Japan The Institute for Adult Disease, Asahi Life Foundation Chuo-ku Tokyo
Japan Tokyo-Eki Center-building Clinic Chuo-ku Tokyo
Japan Steel Memorial Yawata Hospital Kitakyushu Fukuoka
Japan Morinaga Ueno Clinic Kumamoto
Japan Tokuyama Clinic Mihama-ku,Chiba City Chiba
Japan MinamiAkatsukaClinic Mito Ibaraki
Japan Abe Clinic Oita
Japan Heishinkai Medical Group ToCROM Clinic Shinjuku-ku Tokyo
Japan Medical Corporation Heishinkai OCROM Clinic Suita-shi Osaka
Japan Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic Yamato-shi Kanagawa
Japan Iwamoto Internal Medicine Clinic Zentsuji Kagawa
Mexico Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos Chihuahua
Mexico Centro de Investigacion Medica Integral Guadalajara Jalisco
Mexico Salud Cardiovascular Guadalajara Jalisco
Mexico Unidad de Investigaci?n Cl?nica Cardiometabolica de Occidente Guadalajara Jalisco
Mexico PanAmerican Clinical Research - Querétaro - Avenida Antea Querétaro
Mexico FAICIC S. de R.L. de C.V. Veracruz
Mexico Instituto Veracruzano en Investigación Clínica S.C. Veracruz
Mexico Centro de Investigacion Medica de Occidente, S.C. Zapopan Jalisco
Puerto Rico Puerto Rico Health Institute Dorado
Puerto Rico Advance Medical Research Center San Juan
United States Billings Clinic Billings Montana
United States Ellipsis Research Group Brooklyn New York
United States Burke Internal Medicine and Research Burke Virginia
United States Invictus Clinical Research Group Coconut Creek Florida
United States The Corvallis Clinic, P.C. Corvallis Oregon
United States Connecticut Clinical Research - Cromwell Cromwell Connecticut
United States Dallas Diabetes Research Center Dallas Texas
United States Revival Research Institute - Dearborn Dearborn Michigan
United States Hillcrest Medical Research DeLand Florida
United States Aventiv Research Dublin Ohio
United States Neighborhood Healthcare Institute of Health Escondido California
United States The Research Center of The Upstate Greenville South Carolina
United States Amir A Hassan, MD, PA Houston Texas
United States Endocrine Ips, Pllc Houston Texas
United States Juno Research Houston Texas
United States National Research Institute - Huntington Park Huntington Park California
United States Family First Medical Center Idaho Falls Idaho
United States The Jackson Clinic Jackson Tennessee
United States MDFirst Research, LLC Lancaster South Carolina
United States Ark Clinical Research Long Beach California
United States National Research Institute - Wilshire Los Angeles California
United States K2 Medical Research Maitland Florida
United States Central New York Clinical Research Manlius New York
United States Global Health Research Center, Inc. Miami Lakes Florida
United States Monroe Biomedical Research Monroe North Carolina
United States American Health Network of IN, LLC Muncie Indiana
United States Lucas Research - New Bern New Bern North Carolina
United States Alliance for Multispecialty Research, LLC New Orleans Louisiana
United States Infinity Clinical Research - Norco Norco California
United States Intend Research, LLC Norman Oklahoma
United States West Orange Endocrinology Ocoee Florida
United States Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair Pittsburgh Pennsylvania
United States Norcal Endocrinology & Internal Medicine San Ramon California
United States Syed Research Consultants Llc Sheffield Alabama
United States Clinical Research Atlanta Stockbridge Georgia
United States Epic Medical Research - Surprise Surprise Arizona
United States Quality of Life Medical & Research Center Tucson Arizona
United States University Clinical Investigators, Inc. Tustin California
United States Rophe Adult and Pediatric Medicine/SKYCRNG Union City Georgia
United States Preferred Primary Care Physicians Uniontown Pennsylvania
United States Tekton Research - Wichita Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  China,  India,  Japan,  Mexico,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 40
Secondary Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol) Week 40
Secondary Percentage of Participants with an HbA1c target value of =6.5% (48 mmol/mol) Week 40
Secondary Change from Baseline in Fasting Serum Glucose Baseline, Week 40
Secondary Percentage Change from Baseline in Body Weight Baseline, Week 40
Secondary Change from Baseline in Body Weight Baseline, Week 40
Secondary Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG) Baseline, Week 40
Secondary Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 40
Secondary Change from Baseline in Non-HDL Cholesterol Baseline, Week 40
Secondary Percentage Change from Baseline in Triglycerides Baseline, Week 40
Secondary Percentage of Participants Who Achieved Weight Loss of =5% Week 40
Secondary Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores Baseline, Week 40
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