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Trial · Interventional

CompletedPhase 3Registry data

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

Short name TRIUMPH-4

NCTNCT05931367 (opens ClinicalTrials.gov in a new tab)Other id18583Other idJ1I-MC-GZBNOther id2023-503660-17-00Other id2023
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
445 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
6 countries

United States, Australia, Canada, Mexico, Spain, United Kingdom

Start
1 Aug 2023
Primary completion
14 Nov 2025
Completion
14 Nov 2025
First posted
5 Jul 2023
Last update posted
21 Jan 2026
Conditions
Obesity · Overweight · Osteo Arthritis Knee

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 3

    TRIUMPH-4

    NCT05931367

    1 Aug 2023 to 14 Nov 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • RetatrutideDrug
  • PlaceboDrug

Arms3

  • Experimental

    Retatrutide Dose 1

    Participants will receive retatrutide subcutaneously (SC).

  • Experimental

    Retatrutide Dose 2

    Participants will receive retatrutide SC.

  • Placebo comparator

    Placebo

    Participants will receive placebo.

Primary outcomes2

Outcomes the sponsor listed as primary.

  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(11)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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