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Orforglipron vs Semaglutide in Type 2 Diabetes (ACHIEVE-3)
NCT06045221Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2023
- Primary completion
- Aug 2025
- Countries
- 6
- Sponsor
- Eli Lilly and Company
- Drugs
- orforglipron
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, open-label trial of orforglipron in type 2 diabetes mellitus (T2DM) (4 arms), sponsored by Eli Lilly and Company. Primary endpoint: Change From Baseline in Hemoglobin A1c at 52 weeks. Started Sep 2023; status: completed.
02
Design
4 arms- Study design
- RandomizedOpen-label
12 mg Orforglipron
1 mg once-daily oral dose increased every 4 weeks to 12 mg once-daily
36 mg Orforglipron
1 mg once-daily oral dose increased every 4 weeks to 36 mg once-daily
7 mg Semaglutide
3 mg once-daily oral dose increased every 4 weeks to 7 mg once-daily
14 mg Semaglutide
3 mg once-daily oral dose increased every 4 weeks to 14 mg once-daily
03
Who it enrols
Adults with Type 2 Diabetes, HbA1c 7.0-10.5%, on stable metformin >=1500 mg/day, with stable body weight. Excludes Type 1 Diabetes, recent ketoacidosis, severe heart failure (NYHA IV), eGFR <45, and active malignancies.
04
Endpoints
Primary
Change From Baseline in Hemoglobin A1c
Secondary
Change From Baseline in Hemoglobin A1c
Percentage of Participants Who Achieved HbA1c <7.0%
Percentage of Participants Who Achieved HbA1c <=6.5%
Percentage of Participants Who Achieved HbA1c <5.7%
Percent Change From Baseline in Body Weight
Change From Baseline in Body Weight
Change From Baseline in Fasting Serum Glucose
Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose
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