Obesity

Retatrutide for the treatment of obesity, obstructive sleep apnea and knee osteoarthritis: Rationale and design of the TRIUMPH registrational clinical trials

Diabetes Obes MetabPublished Design and rationale of a randomised trial programme

Study context

Population
Adults with obesity, incl. OSA and/or knee osteoarthritis (OA) protocols (TRIUMPH-1, −2), CVD (TRIUMPH-3), stand-alone OA trial (TRIUMPH-4)over 5800 planned
Planned comparison
Weekly subcutaneous retatrutide vs placebo, with healthy diet and physical activity
Primary endpoint
Weight management: % change in body weight; OSA: change in Apnea-Hypopnea Index; knee OA: includes change in WOMAC pain subscale score
Methodological details4 phase 3 trials, multicenter, randomized, double-blind, placebo-controlled, basket trial design, Type I error rate controlled at α = 0.05, split between overarching weight management and each basket trial
  • 4 phase 3 trials
  • Multicenter
  • Randomized
  • Double-blind
  • Placebo-controlled
  • Basket trial design
  • Type I error rate controlled at α = 0.05, split between overarching weight management and each basket trial

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Retatrutide for the treatment of obesity, obstructive sleep apnea and knee osteoarthritis: Rationale and design of the TRIUMPH registrational clinical trials. Diabetes Obes Metab. Published 15 October 2025. doi:10.1111/dom.70209

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