drugset / Trial / NCT06045221

A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

NCT06045221 ↗

Phase 3 Completed 1698 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to assess efficacy and safety of orforglipron compared with oral semaglutide in participants with Type 2 diabetes and inadequate glycemic control with metformin.The study will last around 61 weeks.

Timeline

Start
2023-09-22
Primary completion
2025-08-22
Completion
2025-08-22

Outcome

Met primary endpoint

paper The primary objective of non-inferiority was met and both orforglipron doses showed superiority to both semaglutide doses, including orforglipron 12 mg versus semaglutide 14 mg. PMID 41765029 ↗

release “At 52 weeks, orforglipron met the primary and all key secondary endpoints across each dose comparison vs. oral semaglutide” lilly.com ↗

release “In ACHIEVE-3, orforglipron outperformed oral semaglutide across the primary and all key secondary endpoints, delivering significantly greater improvements in A1C and weight.” lilly.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Orforglipron Small molecule 12 mg Oral
Subject Orforglipron Small molecule 36 mg Oral
Comparator Semaglutide Peptide 7 mg Oral
Comparator Semaglutide Peptide 14 mg Oral