Skip to main content
OpenTrials
Completed

NCT Number: NCT05929079

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, Buenos Aires, Buenos Aires F.D., Argentina

Loading trial locations.

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) 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.

Treatment and study plan

Retatrutide

Drug

Administered SC

Other names: LY3437943

Placebo

Drug

Administered SC

Primary outcomes

  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

  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

    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

    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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Acronym: TRIUMPH-2

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2023
Registry last updated
Jul 30, 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.

Published trials that share one or more normalized conditions with this study.