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Completed

NCT Number: NCT05931367

A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Osteo Arthritis Knee Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Paratus Clinical Research Canberra, Bruce, Australian Capital Territory, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Have diabetes mellitus.

Treatment and study plan

Retatrutide

Drug

Administered SC

Other names: LY3437943

Placebo

Drug

Administered SC

Primary outcomes

  1. Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score

    Time frame: Baseline, Week 68

  2. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 68

Secondary outcomes

  1. Change from Baseline in the WOMAC Physical Function Subscale Score

    Time frame: Baseline, Week 68

  2. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 68

  3. Percent Change from Baseline in Total Cholesterol

    Time frame: Baseline, Week 68

  4. Percent Change from Baseline in Triglycerides

    Time frame: Baseline, Week 68

  5. Change from Baseline in Body Mass Index (BMI)

    Time frame: Baseline, Week 68

  6. Change from Baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 68

  7. Change from Baseline in Diastolic Blood Pressure (DBP)

    Time frame: Baseline, Week 68

  8. Percent Change from Baseline in Fasting Insulin

    Time frame: Baseline, Week 68

  9. Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score

    Time frame: Baseline, Week 68

  10. Change from Baseline in Average Pain Intensity Numeric Rating Score (API-NRS) Score

    Time frame: Baseline, Week 68

  11. Change from Baseline in Worst Pain Intensity Numeric Rating Score (WPI-NRS) Score

    Time frame: Baseline, Week 68

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Acronym: TRIUMPH-4

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2023
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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