The Phase 3 trial (NCT05872620) investigating orforglipron in adult participants with obesity or overweight and type 2 diabetes completed its primary study phase on 2025-08-08. This milestone indicates the completion of the main data collection period for the trial, which enrolled 1613 participants.
Background
Orforglipron is an investigational oral treatment being evaluated for its potential in managing obesity or overweight in individuals also living with type 2 diabetes. These conditions often require comprehensive management strategies to improve patient outcomes and quality of life.
Trial design
The study, titled "A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes" (NCT05872620), is a Phase 3, randomized trial. It enrolled 1613 adult participants diagnosed with obesity or who are overweight and also have type 2 diabetes. The trial is investigating the safety and efficacy of once-daily oral treatment with orforglipron compared with placebo on body weight. The study is designed to last approximately 77 weeks and may include up to 22 visits per participant.
What this means
The primary completion of this Phase 3 trial for orforglipron marks a crucial step in its development as a potential oral therapeutic option. Following this completion, researchers will analyze the collected data to assess the drug's efficacy in body weight reduction and its overall safety profile in the target population. The findings from this study will be essential for understanding orforglipron's role in the management of obesity or overweight in patients with type 2 diabetes and could inform future regulatory submissions.
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 NCT05872620, titled "A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes," was posted on 2025-08-08 on clinicaltrials.gov.