A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee (TRIUMPH-4)
title:
A Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Trial
medical condition:
Obesity | Overweight | Osteo Arthritis Knee
age:
18+
sex/gender:
All
Overview
The main purpose of this study is to evaluate the safety and efficacy of retatrutide once-weekly in participants who have obesity or are overweight and have osteoarthritis (OA) of the knee. The study will lasts about 77 weeks.
Study Details
Inclusion Criteria:
Have a body mass index (BMI) ≥27 kilogram/kg/m² at screening.
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Have index knee pain for >12 weeks prior to screening, and presence of index knee pain for >15 days over the previous month.
Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening.
Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.
Exclusion Criteria:
Have had steroid joint injections within 90 days of screening.
Have had other joint injections and procedures within 6 months of screening.
Have joint disease other than osteoarthritis.
Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days prior to screening.
Have been taking weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
Have a prior or planned surgical treatment for obesity.
