Trial · Interventional
Active, not recruitingPhase 3Registry dataEffect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)
Overview
- Status
- Active, not recruiting
- Phase
- Phase 3
- Enrollment
- 320 participants (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Design
- Randomized · Double masking
- Countries
7 countries
United States, Argentina, Brazil, Israel, Mexico, Puerto Rico, United Kingdom
- Start
- 15 Mar 2024
- Primary completion
- Oct 2026 (estimated)
- Completion
- Nov 2026 (estimated)
- First posted
- 7 Mar 2024
- Last update posted
- 20 Jul 2026
- Conditions
- Type 2 Diabetes
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)
NCT0629760315 Mar 2024 to est. Nov 2026
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 placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.
Interventions
- RetatrutideDrug
- PlaceboDrug
Arms4
Experimental
Retatrutide Dose 1
Participants will receive retatrutide administered subcutaneously (SC).
Experimental
Retatrutide Dose 2
Participants will receive retatrutide administered SC.
Experimental
Retatrutide Dose 3
Participants will receive retatrutide administered SC.
Placebo comparator
Placebo
Participants will receive placebo administered SC.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Time frame · Baseline, Week 52
Secondary outcomes(13)
Percentage of Participants Achieving HbA1c <7.0%
Time frame · Week 52
Percentage of Participants Achieving HbA1c ≤6.5%
Time frame · Week 52
Change from Baseline in Fasting Serum Glucose
Time frame · Baseline, Week 52
Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL
Time frame · Week 52
Registry description
Measured during the CGM session that occurs during 30 days prior to Week 52
Percent Change from Baseline in Body Weight
Time frame · Baseline, Week 52
Change from Baseline in Body Weight
Time frame · Baseline, Week 52
Percentage of Participants Achieving Weight Reduction of ≥5%
Time frame · Week 52
Percentage of Participants Achieving Weight Reduction of ≥10%
Time frame · Week 52
Percentage of Participants Achieving Weight Reduction of ≥15%
Time frame · Week 52
Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction
Time frame · Week 52
Percent Change from Baseline in Non-HDL Cholesterol
Time frame · Baseline, Week 52
Percent Change from Baseline in Triglycerides
Time frame · Baseline, Week 52
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame · Baseline, Week 52
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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