NCT06192108CompletedPhase 3
A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-2)
Eli Lilly and Company74 sites in 4 countries962 target enrollmentStarted: January 10, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 962
- Locations
- 74
- Primary Endpoint
- Change from Baseline in Hemoglobin A1c: (HbA1c)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Orforglipron Dose 3
Experimental
Participants will receive orforglipron orally.
Intervention: Orforglipron (Drug)
Orforglipron Dose 1
Experimental
Participants will receive orforglipron orally.
Intervention: Orforglipron (Drug)
Orforglipron Dose 2
Experimental
Participants will receive orforglipron orally.
Intervention: Orforglipron (Drug)
Dapagliflozin
Active Comparator
Participants will receive dapagliflozin orally.
Intervention: Dapagliflozin (Drug)
Outcomes
Primary Outcomes
Change from Baseline in Hemoglobin A1c: (HbA1c)
Time Frame: Baseline, Week 40
Secondary Outcomes
- Percentage Change from Baseline in Triglycerides(Baseline, Week 40)
- Percentage of Participants Who Achieved Weight Loss of ≥10% from baseline(Baseline to 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 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)
Investigators
Study Sites (74)
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