A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
- Registration Number
- NCT05971940
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 559
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orforglipron Dose 3 Orforglipron Participants will receive orforglipron orally. Placebo Placebo Participants will receive placebo orally. Orforglipron Dose 1 Orforglipron Participants will receive orforglipron orally. Orforglipron Dose 2 Orforglipron Participants will receive orforglipron orally.
- Primary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 40
- Secondary Outcome Measures
Name Time Method Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol) Week 40 Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol) Week 40 Change from Baseline in Fasting Serum Glucose Baseline, Week 40 Percentage Change from Baseline in Body Weight Baseline, Week 40 Change from Baseline in Body Weight Baseline, Week 40 Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG) Baseline, Week 40 Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 40 Change from Baseline in Non-HDL Cholesterol Baseline, Week 40 Percentage Change from Baseline in Triglycerides Baseline, Week 40 Percentage of Participants Who Achieved Weight Loss of ≥5% Week 40 Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores Baseline, Week 40
Trial Locations
- Locations (88)
Alliance for Multispecialty Research, LLC
🇺🇸Norman, Oklahoma, United States
Salud Cardiovascular
🇲🇽Guadalajara, Jalisco, Mexico
BSES MG Hospital
🇮🇳Mumbai, Maharashtra, India
PanAmerican Clinical Research - Querétaro - Avenida Antea
🇲🇽Querétaro, Mexico
FAICIC S. de R.L. de C.V.
🇲🇽Veracruz, Mexico
Puerto Rico Health Institute
🇵🇷Dorado, Puerto Rico
Instituto Veracruzano en Investigación Clínica S.C.
🇲🇽Veracruz, Mexico
Advance Medical Research Center
🇵🇷San Juan, Puerto Rico
Velocity Clinical Research, Westlake
🇺🇸Los Angeles, California, United States
Tekton Research - Wichita
🇺🇸Wichita, Kansas, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
🇺🇸Union City, Georgia, United States
Ark Clinical Research
🇺🇸Long Beach, California, United States
Velocity Clinical Research, Dallas
🇺🇸Dallas, Texas, United States
Endocrine Ips, Pllc
🇺🇸Houston, Texas, United States
Ellipsis Research Group - Brooklyn - 7th Street
🇺🇸Brooklyn, New York, United States
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
🇺🇸Pittsburgh, Pennsylvania, United States
Global Health Research Center, Inc.
🇺🇸Miami Lakes, Florida, United States
The Research Center of The Upstate
🇺🇸Greenville, South Carolina, United States
Velocity Clinical Research, Huntington Park
🇺🇸Huntington Park, California, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
Beijing Pinggu District Hospital
🇨🇳Beijing, Beijing, China
Iwamoto Clinic
🇯🇵Zentsuji, Kagawa, Japan
Shunde Hospital of Southern Medical Univesity
🇨🇳Foshan, Guangdong, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
🇯🇵Yamato-shi, Kanagawa, Japan
Family First Medical Center
🇺🇸Idaho Falls, Idaho, United States
Lucas Research - New Bern
🇺🇸New Bern, North Carolina, United States
MDFirst Research, LLC
🇺🇸Lancaster, South Carolina, United States
GMERS Medical College and General Hospital
🇮🇳Baroda, Gujarat, India
Beijing Hospital
🇨🇳Beijing, Beijing, China
The Corvallis Clinic, P.C.
🇺🇸Corvallis, Oregon, United States
Steel Memorial Yahata Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Hayashi Diabetes Internal Medicine Clinic
🇯🇵Chigasaki, Kanagawa, Japan
Tokuyama Clinic
🇯🇵Mihama-ku,Chiba City, Chiba, Japan
Juno Research
🇺🇸Houston, Texas, United States
Medstar Speciality Hospital
🇮🇳Bangalore, Karnataka, India
Luhe Hospital
🇨🇳Beijing, Beijing, China
Abe Clinic
🇯🇵Oita, Japan
M S Ramaiah Medical College and Hospitals
🇮🇳Bangalore, Karnataka, India
Medical Corporation Heishinkai OCROM Clinic
🇯🇵Suita-shi, Osaka, Japan
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Hasegawa Medical Clinic
🇯🇵Chitose, Hokkaido, Japan
Madras Diabetes Research Foundation
🇮🇳Chennai, Tamil Nadu, India
Wannan Medical College Yijishan Hospital
🇨🇳Wuhu, Anhui, China
Huizhou Municipal Central Hospital
🇨🇳Huizhou, Guangdong, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
West China Hospital of Sichuan University
🇨🇳Cheng Du, Sichuan, China
Pudong New Area People's Hospital Shanghai
🇨🇳Shanghai, Shanghai, China
Quality of Life Medical & Research Center
🇺🇸Tucson, Arizona, United States
Syed Research Consultants Llc
🇺🇸Sheffield, Alabama, United States
Epic Medical Research - Surprise
🇺🇸Surprise, Arizona, United States
Neighborhood Healthcare Institute of Health
🇺🇸Escondido, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Norcal Endocrinology & Internal Medicine
🇺🇸San Ramon, California, United States
Connecticut Clinical Research - Cromwell
🇺🇸Cromwell, Connecticut, United States
Invictus Clinical Research Group
🇺🇸Coconut Creek, Florida, United States
Hillcrest Medical Research
🇺🇸DeLand, Florida, United States
K2 Medical Research
🇺🇸Maitland, Florida, United States
West Orange Endocrinology
🇺🇸Ocoee, Florida, United States
American Health Network of Indiana, LLC - Muncie
🇺🇸Muncie, Indiana, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Revival Research Institute
🇺🇸Dearborn, Michigan, United States
Central New York Clinical Research
🇺🇸Manlius, New York, United States
Monroe Biomedical Research
🇺🇸Monroe, North Carolina, United States
Centricity Research Dublin Multispecialty
🇺🇸Dublin, Ohio, United States
Nanyang First People's Hospital
🇨🇳Nanyang, Henan, China
Amir A Hassan, MD, PA
🇺🇸Houston, Texas, United States
The Second Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
All India Institute of Medical Sciences (AIIMS) - Nagpur
🇮🇳Nagpur, Maharashtra, India
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
🇮🇳Kolkata, West Bengal, India
MinamiAkatsukaClinic
🇯🇵Mito, Ibaraki, Japan
Heishinkai Medical Group ToCROM Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan
Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
🇲🇽Guadalajara, Jalisco, Mexico
Morinaga Ueno Clinic
🇯🇵Kumamoto, Japan
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
🇲🇽Chihuahua, Mexico
Grant Medical Foundation - Ruby Hall Clinic
🇮🇳Pune, Maharashtra, India
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
Centro de Investigacion Medica de Occidente, S.C.
🇲🇽Zapopan, Jalisco, Mexico
Kumudini Devi Diabetes Research Center
🇮🇳Hyderabad, Telangana, India
Burke Internal Medicine and Research
🇺🇸Burke, Virginia, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
Infinity Clinical Research - Norco
🇺🇸Norco, California, United States
Centro de Investigacion Medica Integral
🇲🇽Guadalajara, Jalisco, Mexico