drugset / Trial / NCT06192108

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

NCT06192108 ↗

Phase 3 Completed 962 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-01-10
Primary completion
2025-09-26
Completion
2025-09-26

Outcome

Met primary endpoint

paper At week 40, for the treatment regimen estimand, all orforglipron doses were non-inferior to dapagliflozin in reducing HbA1c. PMID 42259339 ↗

paper estimated treatment difference versus dapagliflozin was -0·42% (95% CI -0·62 to -0·23), -0·70% (-0·90 to -0·49), and -0·75% (-0·96 to -0·55) PMID 42259339 ↗

release “ACHIEVE-2, orforglipron lowered A1C by up to 1.7% compared to 0.8% with dapagliflozin, meeting the primary endpoint” lilly.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dapagliflozin Small molecule 10 mg Oral
Subject Orforglipron Small molecule 3 mg Oral
Subject Orforglipron Small molecule 12 mg Oral
Subject Orforglipron Small molecule 36 mg Oral