NCT05971940CompletedPhase 3
A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 559 (actual)
- First submitted
- 25 Jul 2023
- Start date
- 9 Aug 2023
- Primary completion date
- 3 Apr 2025
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 2 diabetes
- NCT number
- NCT05971940
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 559
- From 9 Aug 2023 to the primary completion date, 3 Apr 2025
- 89 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Have Type 1 Diabetes
- Have New York Heart Association functional classification IV congestive heart failure.
Other
- Have acute or chronic pancreatitis
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (89)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Luhe Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Pinggu District Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Shunde Hospital of Southern Medical Univesity Coordinator of this site? Confirm its status | Foshan | China | Unknown status |
| The Fourth Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Huizhou Municipal Central Hospital Coordinator of this site? Confirm its status | Huizhou | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Nanjing First Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Nanyang First People's Hospital Coordinator of this site? Confirm its status | Nanyang | China | Unknown status |
| Pudong New Area People's Hospital Shanghai Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Wannan Medical College Yijishan Hospital Coordinator of this site? Confirm its status | Wuhu | China | Unknown status |
| The Second Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
| Medstar Speciality Hospital Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| M S Ramaiah Medical College and Hospitals Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Madras Diabetes Research Foundation Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| Kumudini Devi Diabetes Research Center Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| BSES MG hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| All India Institute of Medical Sciences (AIIMS) - Nagpur Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| Grant Medical Foundation Ruby Hall Clinic Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| GMERS Medical College and General Hospital Coordinator of this site? Confirm its status | Vadodara | India | Unknown status |
| Hayashi Diabetes Internal Medicine Clinic Coordinator of this site? Confirm its status | Chigasaki | Japan | Unknown status |
| Hasegawa Medical Clinic Coordinator of this site? Confirm its status | Chitose | Japan | Unknown status |
| Tokyo-Eki Center-building Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Fukuwa Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| The Institute of Medical Science, Asahi Life Foundation Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Steel Memorial Yahata Hospital Coordinator of this site? Confirm its status | Kitakyushu | Japan | Unknown status |
| Morinaga Ueno Clinic Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Tokuyama Clinic Coordinator of this site? Confirm its status | Mihama-ku,Chiba City | Japan | Unknown status |
| MinamiAkatsukaClinic Coordinator of this site? Confirm its status | Mito | Japan | Unknown status |
| Abe Clinic Coordinator of this site? Confirm its status | Ōita | Japan | Unknown status |
| Heishinkai Medical Group ToCROM Clinic Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Medical Corporation Heishinkai OCROM Clinic Coordinator of this site? Confirm its status | Suita-shi | Japan | Unknown status |
| Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic Coordinator of this site? Confirm its status | Yamato-shi | Japan | Unknown status |
| Iwamoto Clinic Coordinator of this site? Confirm its status | Zentsujichó | Japan | Unknown status |
| Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Centro de Investigacion Medica Integral Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Salud Cardiovascular Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| PanAmerican Clinical Research - Querétaro - Avenida Antea Coordinator of this site? Confirm its status | Querétaro | Mexico | Unknown status |
| Instituto Veracruzano en Investigación Clínica S.C. Coordinator of this site? Confirm its status | Veracruz | Mexico | Unknown status |
| FAICIC S. de R.L. de C.V. Coordinator of this site? Confirm its status | Veracruz | Mexico | Unknown status |
| Centro de Investigacion Medica de Occidente, S.C. Coordinator of this site? Confirm its status | Zapopan | Mexico | Unknown status |
| Puerto Rico Health Institute Coordinator of this site? Confirm its status | Dorado | Puerto Rico | Unknown status |
| Advance Medical Research Center Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Billings Clinic Coordinator of this site? Confirm its status | Billings | United States | Unknown status |
| Ellipsis Research Group - Brooklyn - 7th Street Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Burke Internal Medicine and Research Coordinator of this site? Confirm its status | Burke | United States | Unknown status |
| Invictus Clinical Research Group Coordinator of this site? Confirm its status | Coconut Creek | United States | Unknown status |
| The Corvallis Clinic, P.C. Coordinator of this site? Confirm its status | Corvallis | United States | Unknown status |
| Connecticut Clinical Research - Cromwell Coordinator of this site? Confirm its status | Cromwell | United States | Unknown status |
| Velocity Clinical Research, Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Revival Research Institute Coordinator of this site? Confirm its status | Dearborn | United States | Unknown status |
| Hillcrest Medical Research Coordinator of this site? Confirm its status | DeLand | United States | Unknown status |
| Centricity Research Dublin Multispecialty Coordinator of this site? Confirm its status | Dublin | United States | Unknown status |
| Neighborhood Healthcare Institute of Health Coordinator of this site? Confirm its status | Escondido | United States | Unknown status |
| The Research Center of the Upstate Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Endocrine Ips, Pllc Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Amir A Hassan, MD, PA Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Juno Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Velocity Clinical Research-Huntington Park Coordinator of this site? Confirm its status | Huntington Park | United States | Unknown status |
| Family First Medical Center Coordinator of this site? Confirm its status | Idaho Falls | United States | Unknown status |
| The Jackson Clinic Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| MDFirst Research, LLC Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| Ark Clinical Research Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Velocity Clinical Research, Westlake Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| K2 Medical Research Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| Central New York Clinical Research Coordinator of this site? Confirm its status | Manlius | United States | Unknown status |
| Global Health Research Center, Inc. Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Monroe Biomedical Research Coordinator of this site? Confirm its status | Monroe | United States | Unknown status |
| American Health Network of Indiana, LLC - Muncie Coordinator of this site? Confirm its status | Muncie | United States | Unknown status |
| Lucas Research - New Bern Coordinator of this site? Confirm its status | New Bern | United States | Unknown status |
| Alliance for Multispecialty Research, LLC Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Infinity Clinical Research - Norco Coordinator of this site? Confirm its status | Norco | United States | Unknown status |
| Alliance for Multispecialty Research, LLC Coordinator of this site? Confirm its status | Norman | United States | Unknown status |
| West Orange Endocrinology Coordinator of this site? Confirm its status | Ocoee | United States | Unknown status |
| Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Norcal Endocrinology & Internal Medicine Coordinator of this site? Confirm its status | San Ramon | United States | Unknown status |
| Syed Research Consultants Llc Coordinator of this site? Confirm its status | Sheffield | United States | Unknown status |
| Clinical Research Atlanta Coordinator of this site? Confirm its status | Stockbridge | United States | Unknown status |
| Epic Medical Research - Surprise Coordinator of this site? Confirm its status | Surprise | United States | Unknown status |
| Quality of Life Medical & Research Center Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| University Clinical Investigators, Inc. Coordinator of this site? Confirm its status | Tustin | United States | Unknown status |
| Rophe Adult and Pediatric Medicine/SKYCRNG Coordinator of this site? Confirm its status | Union City | United States | Unknown status |
| Preferred Primary Care Physicians Coordinator of this site? Confirm its status | Uniontown | United States | Unknown status |
| Tekton Research - Wichita Coordinator of this site? Confirm its status | Wichita | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.