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Trial · Interventional

CompletedPhase 3Registry data

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

Short name TRIUMPH-1

NCTNCT05929066 (opens ClinicalTrials.gov in a new tab)Other id18557Other idJ1I-MC-GZBJOther idJ1I-MC-GOA1Other idJ1I-MC-GSA1

Overview

Status
Completed
Phase
Phase 3
Enrollment
2,335 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
12 countries

United States, Australia, Brazil, Canada, Hungary, India, Mexico, Poland, Puerto Rico, Romania, Spain, United Kingdom

Start
10 Jul 2023
Primary completion
6 Apr 2026
Completion
30 Apr 2026
First posted
3 Jul 2023
Last update posted
21 Aug 2026
Conditions
Obesity · Overweight · Osteoarthritis, Knee · Obstructive Sleep Apnea

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20232024202520262027
  1. Ph 3

    TRIUMPH-1

    NCT05929066

    10 Jul 2023 to 30 Apr 2026

Registry summary

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

The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.

Interventions

  • RetatrutideDrug
  • PlaceboDrug

Arms5

  • Experimental

    Retatrutide Dose 1

    Participants will receive retatrutide subcutaneously (SC).

  • Experimental

    Retatrutide Dose 2

    Participants will receive retatrutide SC.

  • Experimental

    Retatrutide Dose 3

    Participants will receive retatrutide SC.

  • Placebo comparator

    Placebo

    Participants will receive placebo.

  • Experimental

    Retatrutide Extension Period

    Participants will receive retatrutide after the placebo-controlled 80 week treatment period for an additional 24 weeks.

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Percent Change From Baseline in Body Weight

    Time frame · Baseline, Week 80

  2. Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset

    Time frame · Baseline, Week 80

  3. Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset

    Time frame · Baseline, Week 80

  4. Percent Change from Baseline in Body Weight in Participants in Extension Subset

    Time frame · Baseline, Week 104

Secondary outcomes(20)
  1. Percent Change from Baseline in Body Weight in Participants with Baseline BMI ≥ 35 kg/m2

    Time frame · Baseline, Week 80

  2. Percentage of Participants who Achieve Body Weight Reduction of ≥ 5%

    Time frame · Baseline through Week 80

  3. Percentage of Participants who Achieve Body Weight Reduction of ≥ 10%

    Time frame · Baseline through Week 80

  4. Percentage of Participants who Achieve Body Weight Reduction of ≥ 15%

    Time frame · Baseline through Week 80

  5. Percentage of Participants who Achieve Body Weight Reduction of ≥ 20%

    Time frame · Baseline through Week 80

  6. Percentage of Participants who Achieve Body Weight Reduction of ≥ 25%

    Time frame · Baseline through Week 80

  7. Percentage of Participants who Achieve Body Weight Reduction of ≥ 30%

    Time frame · Baseline through Week 80

  8. Percentage of Participants who Achieve Body Weight Reduction of ≥ 35%

    Time frame · Baseline through Week 80

  9. Change from Baseline in Waist Circumference

    Time frame · Baseline, Week 80

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

    Time frame · Baseline, Week 80

  11. Percent Change from Baseline in Triglycerides

    Time frame · Baseline, Week 80

  12. Percent Change from Baseline in Non-High-Density Lipoprotein (HDL)-Cholesterol

    Time frame · Baseline, Week 80

  13. Percent Change form Baseline in Fasting Insulin

    Time frame · Baseline, Week 80

  14. Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

    Time frame · Baseline, Week 80

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

    Time frame · Baseline, Week 80

  16. Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trial (IWQOL-Lite-CT) Physical Function Composite Score

    Time frame · Baseline, Week 80

  17. Change from Baseline in IWQOL-Lite-CT Psychosocial Composite Score

    Time frame · Baseline, Week 80

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

    Time frame · Baseline, Week 80

  19. Percentage of Participants who Achieve Waist-to-Height Ratio (WHtR) <0.5

    Time frame · Baseline through Week 80

  20. Change from Baseline in HbA1c

    Time frame · Baseline, Week 80

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2026

16 results

Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity.

Jastreboff et al. 2026The New England journal of medicine

PMID 42814954DOI 10.1056/nejmoa2604169PUB-42814954

Full text at the publisher16 results

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 body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following: * hypertension * dyslipidemia * obstructive sleep apnea, or * cardiovascular disease * History of at least one unsuccessful dietary effort to reduce body weight GOA1 Inclusion Criteria: * 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. GSA1 Inclusion Criteria: * Previously diagnosed with OSA * Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA) * For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening. * If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits. GZBJ Addenda (2) inclusion criteria: * Have completed the final treatment visit of GZBJ Week 80. Exclusion Criteria: * Have a self-reported or documented change in body weight \>5 kg (11 pounds) within 90 days. * Have taken 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. * Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * Have had pancreatitis. GOA1 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. GSA1 exclusion criteria * Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening. * Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening. * Use a dental appliance or other device to treat OSA other than PAP therapy. GZBJ Addenda (2) exclusion criteria * Have had study intervention discontinuation. * Have had permanent dose reduction.

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