Phase 3 · NCT06354660
Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)
A Phase 3, Randomized, Multicenter, Double-Blind Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)
Registry record
Trial details
- Trial
- Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)
- ClinicalTrials.gov ID
- NCT06354660
- Indication
- Diabetes Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Eli Lilly and Company
- Enrolment
- 537
- Status
- Completed
- Interventions
- Drug: Retatrutide; Drug: Placebo
- Comparator
- Placebo
- Eligible ages
- 18 Years – No maximum
- Locations
- 48 sites · India, Mexico, Puerto Rico, United States
- Study start
- 10 Apr 2024
- Primary completion
- 22 Jan 2026
- Study completion
- 20 Feb 2026
Verification
- Last verified
- 4 Sept 2026
- Source
- ClinicalTrials.gov
- Registry last updated
- 5 Mar 2026
Endpoints
Primary
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Secondary
Percentage of Participants Who Achieve HbA1c < 7.0%; Percentage of Participants Who Achieve HbA1c ≤ 6.5%; Percentage of Participants Who Achieve HbA1c < 5.7%; Change from Baseline in Fasting Serum Glucose; Percent Change from Baseline in Body Weight; Change from Baseline in Body Weight; Percentage of Participants Who Achieve Weight Reduction of ≥ 5%; Percentage of Participants Who Achieve Weight Reduction of ≥ 10%; Percentage of Participants Who Achieve Weight Reduction of ≥ 15%; Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction; Percent Change from Baseline in Triglycerides; Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol; Change from Baseline in Systolic Blood Pressure (SBP)