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

• Status: Recruiting
• Trial end date: 2025-10-27
• Target enrollment: 0
• Participant gender: All

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 inadequate glycemic control using metformin. The study will last approximately 46 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.