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

NCT05929079
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Participants
1,152
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Start date
2023-07-11
clinicaltrials.gov
Number of sites
98
clinicaltrials.gov

Summary
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.
clinicaltrials.gov
Acronym
TRIUMPH-2
clinicaltrials.gov
Short title
A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight
clinicaltrials.gov
Official title
A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight: A Randomized Double-Blind, Placebo-Controlled Trial
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2026-06-16
clinicaltrials.gov
First posted
2023-07-03
clinicaltrials.gov
Registry last updated
2026-07-30
clinicaltrials.gov
Primary completion date
2026-06-16
clinicaltrials.gov
Start date
2023-07-11
clinicaltrials.gov

Actual participants
1,152
clinicaltrials.gov
Participants
1,152
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
1
clinicaltrials.gov
Number of sites
98
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05929079
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05929079
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Percent Change from Baseline in Body Weight

    Timeframe: Baseline, Week 80

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

    Timeframe: Baseline, Week 80

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

    Timeframe: Baseline, Week 80

  2. Change from Baseline in Waist Circumference

    Timeframe: Baseline, Week 80

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

    Timeframe: Baseline, Week 80

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

    Timeframe: Baseline, Week 80

  5. Percent Change from Baseline in Total Cholesterol

    Timeframe: Baseline, Week 80

  6. Percent Change from Baseline in Triglycerides

    Timeframe: Baseline, Week 80

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

    Timeframe: Baseline, Week 80

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

    Timeframe: Baseline, Week 80

  9. Change from Baseline in Fasting Glucose

    Timeframe: Baseline, Week 80

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

    Timeframe: Baseline through Week 80

    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

    Timeframe: 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

    Timeframe: Baseline to Week 80

    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

    Timeframe: 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

    Timeframe: Week 80

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Pinnacle Research Group, LLCAnniston, United States
  • Cullman Clinical TrialsCullman, United States
  • Preferred Research PartnersLittle Rock, United States
  • Core Healthcare GroupCerritos, United States
  • Velocity Clinical Research, WestlakeLos Angeles, United States
  • Valley Clinical Trials, Inc.Northridge, United States
  • Diablo Clinical Research, Inc.Walnut Creek, United States
  • Chase Medical Research, LLCWaterbury, United States
  • Excel Medical Clinical TrialsBoca Raton, United States
  • Teradan Clinical Trials, LLCBrandon, United States
  • Fleming Island Center for Clinical ResearchFleming Island, United States
  • Therafirst Medical CenterFort Lauderdale, United States
  • Clinical Site Partners LLC, dba Flourish ResearchMiami, United States
  • Quantum Clinical TrialsMiami Beach, United States
  • Renstar Medical ResearchOcala, United States
  • Clinical Research Center of FloridaPompano Beach, United States
  • Palm Beach Research CenterWest Palm Beach, United States
  • Clinical Site Partners, LLC dba Flourish ResearchWinter Park, United States
  • NeuroTrials Research IncAtlanta, United States
  • Centricity Research Rincon PulmonologyRincon, United States
  • East-West Medical Research InstituteHonolulu, United States
  • Brengle Family MedicineIndianapolis, United States
  • MedVadis Research CorporationWaltham, United States
  • StudyMetrix ResearchCity of Saint Peters, United States
  • Las Vegas Medical ResearchLas Vegas, United States

And 73 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-503658-11-00
  • J1I-MC-GSA2
  • J1I-MC-GZBK
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)

Targets (3)