Orforglipron Phase 3 Trial for Type 2 Diabetes Reaches Primary Completion

A Phase 3 clinical trial (NCT06109311) investigating orforglipron in participants with Type 2 Diabetes and inadequate glycemic control with insulin glargine, with or without metformin and/or SGLT-2 inhibitor, reached its primary completion on 2025-09-15. This milestone indicates that data collection for the study's primary endpoint has concluded.

Background

The study's main purpose is to determine the safety and efficacy of orforglipron. It focuses on participants with Type 2 Diabetes who have not achieved adequate glycemic control despite treatment with insulin glargine, which may also include metformin and/or an SGLT-2 inhibitor.

Trial design

The study, identified as NCT06109311, is a Phase 3 trial that enrolled 546 participants. It investigates orforglipron in comparison to placebo for the treatment of Type 2 Diabetes. The trial is designed to last approximately 46 weeks and may involve up to 20 visits for participants.

What this means

The primary completion of a Phase 3 trial signifies that all data collection for the study's primary endpoint has concluded. For Orforglipron in Type 2 Diabetes, this crucial milestone means the next steps will involve comprehensive data analysis and the subsequent reporting of results. These findings will be critical in evaluating the safety and efficacy profile of orforglipron as a potential new oral treatment option for participants with Type 2 Diabetes who have inadequate glycemic control despite current insulin glargine therapy, with or without metformin and/or SGLT-2 inhibitors. The outcome of this study will inform regulatory decisions and potentially impact future treatment guidelines for this patient population.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT06109311, titled "A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor," was recorded on 2025-09-15 on clinicaltrials.gov.