Orforglipron Phase 3 Long-Term Safety Study in Type 2 Diabetes Completes

The Phase 3 long-term safety study for orforglipron (NCT06010004) in participants with Type 2 Diabetes reached its primary completion on 2025-06-05. This study aimed to determine the long-term safety profile of orforglipron when used as a monotherapy or in combination with other oral antihyperglycemic medications.

Background

Type 2 Diabetes is a chronic condition characterized by high blood sugar levels, often resulting from insulin resistance or insufficient insulin production. Effective long-term management is crucial to prevent complications. This study, titled "A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes," focused specifically on gathering extensive safety data for orforglipron over an extended period.

Trial design

The study, identified as NCT06010004, was a Phase 3 trial designed to assess the long-term safety of orforglipron. It enrolled 466 participants diagnosed with Type 2 Diabetes. The intervention involved administering orforglipron. The trial structure included a screening and lead-in period of up to 4 weeks, followed by a treatment period of 52 weeks, which encompassed 20 weeks of dose escalation. A safety follow-up period of 2 weeks concluded the study.

What this means

The primary completion of this Phase 3 study signifies that all participants have concluded their scheduled visits, and the collection of primary safety data is complete. This milestone is crucial for the ongoing development of orforglipron, as comprehensive long-term safety data is a key requirement for regulatory submissions and understanding the drug's profile in a real-world treatment context. The data collected will inform the overall risk-benefit assessment of orforglipron for patients with Type 2 Diabetes, whether used alone or with other oral medications.

Source

The information regarding the primary completion of this clinical trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT06010004, titled "A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes," was posted with a primary completion date of 2025-06-05 on clinicaltrials.gov.