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

Phase 3

Active, not recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: Orforglipron; Drug: Dapagliflozin

• Registration Number: NCT06192108
• Lead Sponsor: Eli Lilly and Company

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2023-12-21
• Study First Posted: 2024-01-05
• Study Start: 2024-01-10
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-02
• Primary Completion: 2025-09
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 888

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orforglipron Dose 2	Orforglipron	Participants will receive orforglipron orally.
Orforglipron Dose 3	Orforglipron	Participants will receive orforglipron orally.
Orforglipron Dose 1	Orforglipron	Participants will receive orforglipron orally.
Dapagliflozin	Dapagliflozin	Participants will receive dapagliflozin orally.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Hemoglobin A1c: (HbA1c)	Baseline, Week 40

Secondary Outcome Measures

Name	Time	Method
Percentage Change from Baseline in Triglycerides	Baseline, Week 40
Change from Baseline in HbA1c	Baseline, Week 40
Change from Baseline in Systolic Blood Pressure (SBP)	Baseline, Week 40
Percentage of Participants Who Achieved Weight Loss of ≥5% from Baseline	Baseline to Week 40
Percentage of Participants Who Achieved Weight Loss of ≥10% from baseline	Baseline to Week 40
Percentage Change from Baseline in Total Cholesterol	Baseline, Week 40
Percentage of Participants Who Achieved HbA1c <7.0% (53 millimole/mole(mmol/mol))	Week 40
Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol)	Week 40
Percentage Change from Baseline in Body Weight	Baseline, Week 40
Change from Baseline in Body Weight	Baseline, Week 40
Percentage Change from Baseline in Non-High-Density Lipoprotein (non-HDL)-Cholesterol	Baseline, Week 40
Change from Baseline in Diastolic Blood Pressure (DBP)	Baseline, Week 40
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Change (DTSQc) Scores	Baseline, Week 40
Change from Baseline in Fasting Serum Glucose	Baseline, Week 40
Percentage of Participants Who Achieved Weight Loss of ≥15% from baseline	Baseline to Week 40
Change from Baseline in Short Form 36 Version 2 (SF-36-v2) Acute Form Domain Summary Scores	Baseline, Week 40

Trial Locations

Locations (74)

Alliance Research Institute - Canoga Park; 🇺🇸 Canoga Park, California, United States

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

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