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Trial · Interventional

Active, not recruitingPhase 1Registry data

A Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellitus

NCTNCT06982859 (opens ClinicalTrials.gov in a new tab)Other id27317Other idJ1I-MC-GZQGOther id2024-518470-13-00

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
2025202620272028
  1. Ph 1

    A Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellitus

    NCT06982859

    2 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  4. Change from Baseline in Second Phase Total ISR

    Time frame · Baseline, Week 28

    Registry description

    Change from baseline in second phase total ISR

  5. Change from Baseline in Total ISR

    Time frame · Baseline, Week 28

    Registry description

    Change from baseline in total ISR

  6. 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 \[Incremental Insulin AUC arginine, 0-10minutes\].

  7. 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).

  8. 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.

  9. 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.

  10. 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

  11. 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)

  12. 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
Inclusion Criteria: * Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 6 months prior to screening. * Treated with diet and exercise and metformin daily, with or without other allowed oral antihyperglycaemia medications (OAMs), 3 months prior to screening. Allowed OAMs are dipeptidyl peptidase-4 inhibitors (DPP-IV) inhibitors, sodium/glucose cotransporter 2 (SGLT2) inhibitors, glinides, and sulfonylureas. * Have a HbA1c value at screening of: * 6.5% and ≤ 9.5 % if on metformin with or without SGLT2 inhibitors, or * 6% and ≤8.5% if on metformin in combination with allowed OAMs that require washout. * Have venous access sufficient to allow for blood sampling as per the protocol. * Have clinical laboratory test results within normal reference range for the population or investigative site or results with acceptable deviations that are judged to be not clinically significant by the investigator. * Have a body mass index (BMI) between 25 kilograms per meter squared (kg/m²) and 45 kg/m², both inclusive, at screening. * Have had a stable body weight that is less than 5% change during the 3-month period prior to screening. Exclusion Criteria: * Have Type 1 Diabetes Mellitus (T1DM) * Have had more than 1 episode of severe hypoglycaemia, as defined by the American Diabetes Association criteria, within 6 months before screening or a history of hypoglycaemia unawareness or poor recognition of hypoglycaemic symptoms; any participant that cannot communicate an understanding of hypoglycaemic symptoms and the appropriate treatment of hypoglycaemia prior to the first dose of study drug should also be excluded. * Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalisation within the 6 months prior to screening. * Are currently receiving, planning to receive, or in need of treatment, that is, intravitreal injections of Vascular Endothelial Growth Factor inhibitor or corticosteroids, focal/grid macular laser surgery, panretinal photocoagulation, or vitrectomy for diabetic retinopathy at screening. * Have impaired renal estimated glomerular filtration rate \<60.0 mL/min/1.73 m² calculated by Chronic Kidney Disease-Epidemiology (2021). * Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis. * Have elevations in: * serum aspartate aminotransferase (AST) \>2.5X the upper limit of normal (ULN) * serum alanine aminotransferase (ALT) \>2.5X ULN * total bilirubin level (TBL) \>1.5X ULN (except, participants with Gilbert's syndrome), or * Alkaline phosphatase (ALP) level ≥1.5X ULN * Show evidence of possible chronic or active hepatitis B, including hepatitis B core antibody and/or hepatitis B surface antigen positivity. * Have a positive Hepatitis C virus (HCV) antibody (Ab) test. Participants with a positive HCV Ab test at screening can be included only if a confirmatory HCV ribonucleic acid (RNA) test is negative. * Have a known clinically significant gastric emptying abnormality, have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery or chronically take drugs that directly affect GI motility. * Have had within 3 months prior to screening: * acute myocardial infarction * congestive heart failure New York Heart Association (NYHA) class III or IV, and/or * cerebrovascular accident \[stroke\] * coronary artery revascularisation * hospitalization hospitalisation for unstable angina * hospitalization hospitalisation due to congestive heart failure. * Have a history of additional risk factors for Torsades de Pointes (for example, heart failure, hypokalaemia, family history of Long QT Syndrome), as judged by the investigator. * Have a 12-lead ECG abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound electrocardiogram (ECG) data analysis. * Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome Type 2 (MEN 2). * Have an active or untreated malignancy or have been in remission from a clinically significant malignancy for \<5 years prior to screening. Exceptions: * basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years * cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline, or * in situ prostate cancer. * Have, in the opinion of the investigator, evidence of significant, uncontrolled endocrine abnormality, for example, thyrotoxicosis or adrenal crisis. * Have a prior or planned surgical treatment for obesity. * Have a prior or planned endoscopic and/or device-based therapy for obesity. * Have taken any glucose-lowering medications other than metformin, DPP IV inhibitors, sulfonylureas and/or SGLT-2 inhibitors, regardless of the indication for use, any time within the 3 months prior to screening. * Have taken prescribed or over-the-counter (OTC) medications, either approved or unapproved, or alternative remedies, including herbal or nutritional supplements, intended to promote body weight reduction, within 3 months prior to screening. * Have evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies. * Have a calcitonin level at screening of ≥35.0 nanograms per liter (ng/L), \[≥35.0 picograms per milliliter (pg/mL)\].

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