Phase 3 · NCT05929079
TRIUMPH-2
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
Registry record
Trial details
- Trial
- TRIUMPH-2
- ClinicalTrials.gov ID
- NCT05929079
- Indication
- Type 2 Diabetes, Obesity, Overweight, Obstructive Sleep Apnea
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Eli Lilly and Company
- Enrolment
- 1,152
- Status
- Completed
- Interventions
- Drug: Retatrutide; Drug: Placebo
- Comparator
- Placebo
- Eligible ages
- 18 Years – No maximum
- Locations
- 98 sites · Argentina, Australia, Brazil, India, Mexico, Romania, Spain, United States
- Study start
- 11 Jul 2023
- Primary completion
- 16 Jun 2026
- Study completion
- 16 Jun 2026
Verification
- Last verified
- 4 Sept 2026
- Source
- ClinicalTrials.gov
- Registry last updated
- 30 Jul 2026
Endpoints
Primary
Percent Change from Baseline in Body Weight; Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset
Secondary
Change from Baseline in Body Mass Index (BMI); Change from Baseline in Waist Circumference; Change from Baseline in Systolic Blood Pressure (SBP); Change from Baseline in Diastolic Blood Pressure (DBP); Percent Change from Baseline in Total Cholesterol; Percent Change from Baseline in Triglycerides; Change from Baseline in Hemoglobin (A1c) HbA1c %; Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score; Change from Baseline in Fasting Glucose; Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC); Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset; 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; Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA2 Subset; Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA2 Subset
Registry monitoring
Latest Trial Changes
| Field | Change | Detected | Source |
|---|---|---|---|
| Recruitment status | Active, not recruiting→Completed | 4 Sept 2026 | ClinicalTrials.gov |
| Enrolment | 1800→1152 | 4 Sept 2026 | ClinicalTrials.gov |
| Primary completion date | 2027-03-31→2026-06-16 | 4 Sept 2026 | ClinicalTrials.gov |
| Study completion date | Data pending→2026-06-16 | 4 Sept 2026 | ClinicalTrials.gov |
| Primary endpoints | Data pending→Percent Change from Baseline in Body Weight; Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset | 4 Sept 2026 | ClinicalTrials.gov |