Trial · Interventional
Active, not recruitingPhase 1Registry dataA Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellitus
Overview
- Status
- Active, not recruiting
- Phase
- Phase 1
- Enrollment
- 95 participants (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Design
- Randomized · Double masking
- Countries
1 country
Germany
- Start
- 2 Jun 2025
- Primary completion
- Jan 2027 (estimated)
- Completion
- Jan 2027 (estimated)
- First posted
- 21 May 2025
- Last update posted
- 6 Oct 2026
- Conditions
- Diabetes Mellitus · Insulin Sensitivity
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
A Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellitus
NCT069828592 Jun 2025 to est. Jan 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The primary objective of Study GZQG is to compare the effect of retatrutide and placebo on total clamp disposition index (cDI) after 28 weeks of treatment.
Interventions
- RetatrutideDrug
- SemaglutideDrug
- PlaceboDrug
Arms3
Experimental
Retatrutide
Retatrutide administered subcutaneously (SC).
Active comparator
Semaglutide
Semaglutide administered SC.
Placebo comparator
Placebo
Placebo administered SC.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change from Baseline in Total Clamp Disposition Index (cDI) for Comparison of Retatrutide With Placebo
Time frame · Baseline, Week 28
Registry description
Change from baseline in total cDI for comparison of retatrutide with placebo
Secondary outcomes(12)
Change from Baseline in cDI for Comparison Between Retatrutide and Semaglutide
Time frame · Baseline, Week 28
Registry description
Change from baseline in total cDI for comparison between retatrutide and semaglutide
Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value
Time frame · Baseline, Week 28
Registry description
Change from baseline in hyperinsulinemic euglycemic clamp M-value
Change from Baseline in First Phase Incremental Insulin Secretion Rate (ISR)
Time frame · Baseline, Week 28
Registry description
Change from baseline in first phase ISR.
Change from Baseline in Second Phase Total ISR
Time frame · Baseline, Week 28
Registry description
Change from baseline in second phase total ISR
Change from Baseline in Total ISR
Time frame · Baseline, Week 28
Registry description
Change from baseline in total ISR
Change from Baseline in Insulin Response to Arginine [Incremental Insulin Area Under the Curve (AUC) arginine, 0-10minutes]
Time frame · Baseline, Week 28
Registry description
Change from baseline in insulin response to arginine \[Incremental Insulin AUC arginine, 0-10minutes\].
Change from Baseline in Insulin Response to Arginine (Incremental Insulin AUC arginine, 0-30minutes)
Time frame · Baseline, Week 28
Registry description
Change from baseline in insulin response to arginine (Incremental Insulin AUC arginine, 0-30minutes).
Change from Baseline in Beta-cell (β-cell) Glucose Sensitivity (GS)
Time frame · Baseline, Week 28
Registry description
Change from baseline in β-cell GS.
Change from Baseline in β-cell Glucose Sensitivity (GS) from Standardized Mixed-Meal Tolerance Test (sMMTT)
Time frame · Baseline, Week 28
Registry description
Change from baseline in β-cell GS from sMMTT.
Change from Baseline in ISR at Fixed Glucose Concentration (ISRg) from sMMTT
Time frame · Baseline, Week 28
Registry description
Change from baseline in ISR at fixed glucose concentration (ISRg) from sMMTT
Change from Baseline Fasting Glucose During sMMTT (Total and Incremental AUC0-240min)
Time frame · Baseline, Week 28
Registry description
Change from baseline fasting glucose during sMMTT (total and incremental AUC0-240min)
Change from Baseline Postmeal Glucose During sMMTT (Total and Incremental AUC0-240min)
Time frame · Baseline, Week 28
Registry description
Change from baseline postmeal glucose during sMMTT (total and incremental AUC0-240min)
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 up to 70 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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