A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Osteoarthritis Knee Pain, and Obesity or Overweight ENLIGHTEN-4

What this Trial Is About

Researchers are studying how well and safely Eloralintide LY3841136, given once weekly, works in adults who are overweight or have obesity and suffer from knee osteoarthritis pain. This study uses a master protocol design to support two independent Phase 3 randomized, double-blind, placebo-controlled trials. It aims to evaluate changes in body weight and knee pain among participants with osteoarthritis and obesity or overweight. Participants will be randomly assigned to receive either Eloralintide or a placebo, both administered by subcutaneous injection. The treatment period lasts about 64 weeks, with dosing occurring once weekly. The study includes a total participation time of approximately 75 weeks, which encompasses screening and follow-up. Both experimental and placebo groups are included to compare the effects of Eloralintide. During the study, participants will undergo assessments including body weight, knee pain scores using the WOMAC pain subscale, physical function, blood pressure, cholesterol levels, inflammatory markers, and walking ability measured by a 6-minute walk test. Researchers will also monitor changes in medication use and safety through regular evaluations. The study collects data from baseline through week 64, with ongoing safety monitoring and outcome measurements throughout the participation period.

Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight