Trial · Interventional
Active, not recruitingPhase 3Registry dataEffect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
Overview
- Status
- Active, not recruiting
- Phase
- Phase 3
- Enrollment
- 1,250 participants (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Design
- Randomized · Open label (no masking)
- Countries
5 countries
United States, Argentina, Canada, Mexico, Puerto Rico
- Start
- 21 Feb 2024
- Primary completion
- 27 Aug 2026
- Completion
- Feb 2027 (estimated)
- First posted
- 15 Feb 2024
- Last update posted
- 28 Sept 2026
- Conditions
- Diabetes Mellitus, Type 2
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
NCT0626072221 Feb 2024 to est. Feb 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits.
Interventions
- RetatrutideDrug
- SemaglutideDrug
Arms3
Experimental
Retatrutide Dose Level 1
Participants will receive retatrutide administered subcutaneously (SC).
Experimental
Retatrutide Dose Level 2
Participants will receive retatrutide administered SC.
Active comparator
Semaglutide
Participants will receive semaglutide administered SC.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Time frame · Baseline, Week 80
Secondary outcomes(12)
Change from Baseline in HbA1c (%)
Time frame · Baseline, Week 80
Percentage of Participants Who Achieve HbA1c ≤ 6.5%
Time frame · Week 80
Percentage of Participants Who Achieve HbA1c < 5.7%
Time frame · Week 80
Percent Change from Baseline in Body Weight
Time frame · Week 80
Change from Baseline in Body Weight
Time frame · Baseline, Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 5%
Time frame · Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 10%
Time frame · Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 15%
Time frame · Week 80
Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction
Time frame · Week 80
Percent Change from Baseline in Triglycerides
Time frame · Week 80
Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol
Time frame · Week 80
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame · Baseline, 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.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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