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Diabetes MellitusPhase 1NCT06982859

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

A Phase 1 study testing Retatrutide and Semaglutide in people with Diabetes Mellitus and Insulin Sensitivity, run by Eli Lilly and Company at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus, Insulin Sensitivity
What is being tested?
Retatrutide and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
95 participants
Where
1 siteGermany
Study dates
2 Jun 2025to Jan 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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)].

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil Institut für Stoffwechselforschung

    Neuss, 41460

Other trials in Germany

About this study

Official title: A Phase 1, Investigator- and Participant-Blinded Study to Evaluate the Effect of Retatrutide on α- and β- Cell Function and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellitus

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.

Being tested
Retatrutide, Semaglutide, Placebo
Medical subject headings
Diabetes Mellitus, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RetatrutideDrug

    Also called LY3437943

    Administered SC

  • SemaglutideDrug

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT06982859
Study groupRoleWhat they receive
RetatrutideExperimentalRetatrutide administered subcutaneously (SC).
Receives: Drug: Retatrutide
SemaglutideActive comparatorSemaglutide administered SC.
Receives: Drug: Semaglutide
PlaceboPlacebo comparatorPlacebo administered SC.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Total Clamp Disposition Index (cDI) for Comparison of Retatrutide With Placebo

    Change from baseline in total cDI for comparison of retatrutide with placebo

    Measured: Baseline, Week 28

Secondary outcomes (12)

  1. Change from Baseline in cDI for Comparison Between Retatrutide and Semaglutide

    Change from baseline in total cDI for comparison between retatrutide and semaglutide

    Measured: Baseline, Week 28

  2. Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value

    Change from baseline in hyperinsulinemic euglycemic clamp M-value

    Measured: Baseline, Week 28

  3. Change from Baseline in First Phase Incremental Insulin Secretion Rate (ISR)

    Change from baseline in first phase ISR.

    Measured: Baseline, Week 28

  4. Change from Baseline in Second Phase Total ISR

    Change from baseline in second phase total ISR

    Measured: Baseline, Week 28

  5. Change from Baseline in Total ISR

    Change from baseline in total ISR

    Measured: Baseline, Week 28

  6. Change from Baseline in Insulin Response to Arginine [Incremental Insulin Area Under the Curve (AUC) arginine, 0-10minutes]

    Change from baseline in insulin response to arginine [Incremental Insulin AUC arginine, 0-10minutes].

    Measured: Baseline, Week 28

  7. Change from Baseline in Insulin Response to Arginine (Incremental Insulin AUC arginine, 0-30minutes)

    Change from baseline in insulin response to arginine (Incremental Insulin AUC arginine, 0-30minutes).

    Measured: Baseline, Week 28

  8. Change from Baseline in Beta-cell (β-cell) Glucose Sensitivity (GS)

    Change from baseline in β-cell GS.

    Measured: Baseline, Week 28

  9. Change from Baseline in β-cell Glucose Sensitivity (GS) from Standardized Mixed-Meal Tolerance Test (sMMTT)

    Change from baseline in β-cell GS from sMMTT.

    Measured: Baseline, Week 28

  10. Change from Baseline in ISR at Fixed Glucose Concentration (ISRg) from sMMTT

    Change from baseline in ISR at fixed glucose concentration (ISRg) from sMMTT

    Measured: Baseline, Week 28

  11. Change from Baseline Fasting Glucose During sMMTT (Total and Incremental AUC0-240min)

    Change from baseline fasting glucose during sMMTT (total and incremental AUC0-240min)

    Measured: Baseline, Week 28

  12. Change from Baseline Postmeal Glucose During sMMTT (Total and Incremental AUC0-240min)

    Change from baseline postmeal glucose during sMMTT (total and incremental AUC0-240min)

    Measured: Baseline, Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2025
  2. Study start2 Jun 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
95 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06982859
Sponsor's protocol ID
27317
Other IDs
J1I-MC-GZQG, 2024-518470-13-00
Status last verified
Oct 2026
First submitted
14 May 2025
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Retatrutide and Semaglutide in people with Diabetes Mellitus and Insulin Sensitivity, run by Eli Lilly and Company at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Total Clamp Disposition Index (cDI) for Comparison of Retatrutide With Placebo (time frame: Baseline, Week 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06982859.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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