Actively Recruiting
A Phase 3 Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee
Led by Eli Lilly and Company · Updated on 2026-06-04
800
Participants Needed
95
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the medication orforglipron in people who are obese or overweight and have osteoarthritis OA of the knee with pain. The study aims to understand how well and safely orforglipron works for this group. This phase 3 trial is sponsored by Eli Lilly and Company and participation will last about 74 weeks. Participants will be randomly assigned to receive either orforglipron or a placebo, both taken orally. The study includes two independent groups within the protocol, each with an orforglipron and placebo arm. Treatments are given once daily, and the trial is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo during the study. During the study, participants will have regular assessments including pain and physical function evaluations using the WOMAC score, body weight measurements, walking tests, and blood tests for inflammation markers. The main outcome is the change in knee pain from the start to week 72. Safety and drug levels in the blood will also be monitored. Participants may use allowed pain medications, and all assessments will help researchers understand the effects of orforglipron over the study period.
CONDITIONS
Brief Title
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a body mass index (BMI) of 27 kilograms per square meter (kg/m2) or higher at screening
- Have tried at least once to lose weight through diet but were unsuccessful
- Have osteoarthritis of the knee and at least one of the following: over 50 years old, morning knee stiffness lasting about 30 minutes, or a crackling or grinding sound or feeling in the knee
You will not qualify if you...
- Have gained or lost more than 11 pounds within 90 days prior to screening
- Have had or plan to have surgery for obesity within the next 18 months
- Have an active knee infection
- Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
- Have had a recent heart condition or New York Heart Association Functional Classification Class IV congestive heart failure
- Have used any glucagon-like peptide-1 (GLP-1) receptor agonist medication within 180 days of screening
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here