Status:
COMPLETED
A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 inadequ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2025
Estimated Enrollment :
962 Patients enrolled
Trial Details
Trial ID
NCT06192108
Start Date
January 10 2024
End Date
September 26 2025
Last Update
October 20 2025
Active Locations (74)
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1
Alliance Research Institute - Canoga Park
Canoga Park, California, United States, 91304
2
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Long Beach, California, United States, 90815
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Los Alamitos, California, United States, 90720
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Santa Ana, California, United States, 92706