drugset / Trial / NCT06010004

A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes

NCT06010004

Phase 3 Completed 401 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication. This study includes 3 periods as follows: * screening and lead-in period: up to 4 weeks * treatment period: 52 weeks, including 20 weeks of dose escalation, and * safety follow-up period: 2 weeks.

Timeline

Start
2023-09-28
Primary completion
2025-06-05
Completion
2025-06-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Orforglipron Small molecule 3 mg Oral
Subject Orforglipron Small molecule 12 mg Oral
Subject Orforglipron Small molecule 36 mg Oral