A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin

Completed · Phase 3

Conditions studied: Type 2 Diabetes

In brief

The main purpose of this study is to assess the safety and efficacy of orforglipron compared with dapagliflozin in improving blood sugar control in participants with type 2 diabetes (T2D) with inadequate glycemic control using metformin. The study will last approximately 46 weeks.

Key facts

Study ID

NCT06192108

Run by

Eli Lilly and Company

People needed

962

Starts

2024-01-10

Expected to finish

2025-09-26

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a clinical diagnosis of T2D based on the World Health Organization classification or other locally applicable diagnostic standards.
• Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.
• Have been on stable diabetes treatment with metformin ≥1500 milligram per day (mg/day) during the 90 days prior to screening and maintained through randomization.
• Are of stable body 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.

You may not qualify if…

• Have Type 1 Diabetes (T1D)
• Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
• Have an estimated glomerular filtration rate (eGFR) <45 milliliter per minute (mL/min)/1.73 square meter (m2)
• Have acute or chronic hepatitis
• Have had chronic or acute pancreatitis any time.
• Have been treated with any antihyperglycemic medication (other than metformin) within the 90 days prior to screening.

Where it is running

• Ark Clinical Research — Long Beach, California, United States
• Collaborative Neuroscience Research, LLC — Los Alamitos, California, United States
• Wolverine Clinical Trials — Santa Ana, California, United States
• CMR of Greater New Haven, LLC — Hamden, Connecticut, United States
• Institute of Endocrinology Diabetes, Health & Hormone — Stockbridge, Georgia, United States
• Elite Clinical Trials — Rexburg, Idaho, United States
• Accellacare - DuPage — Lombard, Illinois, United States
• Tandem Clinical Research — Marrero, Louisiana, United States
• St. Vincent Healthcare — Billings, Montana, United States
• Albuquerque Clinical Trials, Inc. — Albuquerque, New Mexico, United States
• Accellacare - Winston-Salem — Winston-Salem, North Carolina, United States
• Alliance for Multispecialty Research, LLC — Norman, Oklahoma, United States
• Essential Medical Research — Tulsa, Oklahoma, United States
• Accellacare - Mt Pleasant — Mt. Pleasant, South Carolina, United States
• Accellacare, US Inc., d/b/a Accellacare of Knoxville — Jefferson City, Tennessee, United States
• Velocity Clinical Research, Dallas — Dallas, Texas, United States
• Juno Research — Houston, Texas, United States
• Consano Clinical Research, LLC — Shavano Park, Texas, United States
• The Second People's Hospital of Hefei — Hefei, Anhui, China
• The Fourth Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China
• The First Affiliated Hospital of Nanyang Medical College — Nanyang, 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
• Alliance Research Institute - Canoga Park — Canoga Park, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.