GLPwatch

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

NCT06010004 · Completed

Last updated 2026-05-28

This clinical trial is testing the long-term safety of the medication Orforglipron (LY3502970) in adults who have type 2 diabetes.

Status Completed The study has finished.
Phase Phase 3 Confirms effectiveness in a large group before approval.
Type Interventional (clinical trial)
Design Randomized, open-label (no blinding) treatment study
Participants 466 people
Who can join Ages 18+ · all sexes
Timeline Started 2023-09 · est. completion 2025-06
Where 40 sites · Japan

What this study is testing ClinicalTrials.gov NCT06010004 ↗

Description as written by the study sponsor.

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.

Treatments tested

Main thing measuredNumber of Participants with Treatment Emergent Adverse Events (TEAEs)
SponsorEli Lilly and Company
Conditions studiedType 2 Diabetes
GLP-1 drugs orforglipron

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06010004 ↗