The Phase 3 study (NCT05869903) investigating orforglipron in adult participants with obesity or overweight with weight-related comorbidities completed its main phase on July 25, 2025. This trial, which enrolled 3127 participants, evaluated the efficacy and safety of once-daily oral orforglipron.
Background
The study, titled "A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities," is designed to assess orforglipron as a treatment for weight management. The drug is being investigated for its potential to help individuals with obesity or who are overweight and have associated health conditions.
Trial design
The Phase 3 study (NCT05869903) is a randomized trial that has enrolled 3127 adult participants. The study is investigating orforglipron in individuals diagnosed with obesity, overweight, or overweight or obesity. Participants receive either orforglipron or a placebo. The trial is structured with a main phase lasting 72 weeks, followed by an extension phase for participants with prediabetes, which will continue for an additional 2 years.
What this means
The primary completion of this large Phase 3 trial marks a significant milestone in the development of orforglipron for the treatment of obesity and overweight with weight-related comorbidities. While specific outcome data from the main phase are not yet available, the completion of this phase indicates that the study has reached its planned duration for the primary efficacy and safety assessments. Future data releases will provide insights into the performance of orforglipron in this substantial 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 NCT05869903, titled "A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities," was posted on July 25, 2025 on clinicaltrials.gov.