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Trial · Interventional

CompletedPhase 3Registry data

A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight

Short name TRIUMPH-2

NCTNCT05929079 (opens ClinicalTrials.gov in a new tab)Other id18558Other idJ1I-MC-GZBKOther idJ1I-MC-GSA2Other id2023-503658-11-00
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
1,152 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
8 countries

United States, Argentina, Australia, Brazil, India, Mexico, Romania, Spain

Start
11 Jul 2023
Primary completion
16 Jun 2026
Completion
16 Jun 2026
First posted
3 Jul 2023
Last update posted
30 Jul 2026
Conditions
Type 2 Diabetes · Obesity · Overweight · Obstructive Sleep Apnea

Timeline

1 trial · 1 completed

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

    TRIUMPH-2

    NCT05929079

    11 Jul 2023 to 16 Jun 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 is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes in participants who have obesity or overweight (J1I-MC-GZBK master protocol) including a subset of participants who have obstructive sleep apnea (OSA) (J1I-MC-GSA2). The study will last about 89 weeks and will include up to 24 visits.

Interventions

  • RetatrutideDrug
  • PlaceboDrug

Arms4

  • 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.

Primary outcomes2

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) for GSA2 Subset

    Time frame · Baseline, Week 80

Secondary outcomes(14)

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

    Time frame · Baseline, Week 80

  2. Change from Baseline in Waist Circumference

    Time frame · Baseline, Week 80

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

    Time frame · Baseline, Week 80

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

    Time frame · Baseline, Week 80

  5. Percent Change from Baseline in Total Cholesterol

    Time frame · Baseline, Week 80

  6. Percent Change from Baseline in Triglycerides

    Time frame · Baseline, Week 80

  7. Change from Baseline in Hemoglobin (A1c) HbA1c %

    Time frame · Baseline, Week 80

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

    Time frame · Baseline, Week 80

  9. Change from Baseline in Fasting Glucose

    Time frame · Baseline, Week 80

  10. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)

    Time frame · Baseline through Week 80

    Registry description

    AUC is presented as a single average measure of AUC across the study duration.

  11. Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset

    Time frame · Baseline, Week 80

  12. A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score for GSA2 Subset

    Time frame · Baseline to Week 80

    Registry description

    A hierarchical combination of change from baseline in the FOSQ 10 score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score will be assessed by the win ratio. The reported unit will be the total "wins" for each treatment group from performing a hierarchical comparison of the component.

  13. Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA2 Subset

    Time frame · Baseline to Week 80

  14. Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA2 Subset

    Time frame · 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

21 results

Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2): a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trial.

Bellido et al. 2026Lancet (London, England)

PMID 42810372DOI 10.1016/s0140-6736(26)01861-1PUB-42810372

Full text at the publisher21 results
Publisher pageSee results (21)

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) greater than or equal to 27.0 kilogram/square meter (kg/m ²) * Have Type 2 Diabetes (T2D) * Are on stable treatment for T2D for at least 90 days * Have a history of at least one unsuccessful dietary effort to lose body weight. GSA2 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. 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 Type 1 diabetes * Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * Have had pancreatitis GSA2 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.

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