Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
NCT06982859

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

Led by Eli Lilly and Company · Updated on 2026-03-03

95

Participants Needed

1

Research Sites

73 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Type 2 Diabetes Mellitus for at least 6 months before screening
  • Treated with diet and exercise plus daily metformin, with or without specific oral antihyperglycaemia medications, for at least 3 months before screening
  • HbA1c between 6.5% and 9.5% if on metformin with or without SGLT2 inhibitors, or between 6% and 8.5% if on metformin plus other allowed medications requiring washout
  • Venous access adequate for blood sampling
  • Clinical lab test results within normal or acceptable ranges
  • Body mass index between 25 and 45 kg/m² at screening
  • Stable body weight with less than 5% change in 3 months before screening
Not Eligible

You will not qualify if you...

  • Diagnosis of Type 1 Diabetes Mellitus
  • More than one severe hypoglycaemia episode in the past 6 months or poor recognition of hypoglycaemia
  • History of ketoacidosis or hyperosmolar state/coma requiring hospitalization in past 6 months
  • Receiving or planning treatments for diabetic retinopathy such as intravitreal injections or laser surgery at screening
  • Estimated glomerular filtration rate below 60 mL/min/1.73 m²
  • Acute or chronic pancreatitis or history of acute idiopathic pancreatitis
  • Elevated liver enzymes above specified limits or abnormal bilirubin or alkaline phosphatase levels
  • Evidence of active or chronic hepatitis B or positive Hepatitis C antibody without a negative confirmatory RNA test
  • Significant gastric emptying abnormalities or prior bariatric surgery
  • Recent history (within 3 months) of serious cardiovascular events such as heart attack, stroke, or hospitalization for heart failure or unstable angina
  • Risk factors for Torsades de Pointes or abnormal ECG deemed risky by investigator
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2
  • Active or untreated malignancy or remission less than 5 years, with some exceptions
  • Significant uncontrolled endocrine disorders
  • Prior or planned surgical or device treatment for obesity
  • Recent use (within 3 months) of certain glucose-lowering medications beyond allowed drugs
  • Use of weight-reducing medications or supplements within 3 months
  • Evidence of HIV infection or positive HIV antibodies
  • Calcitonin level above 35 ng/L at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Profil Institut für Stoffwechselforschung

Neuss, Germany, 41460

Actively Recruiting

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Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

P

Physicians interested in becoming principal investigators please contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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