Actively Recruiting
A Phase 1, Double-Blind Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Sensitivity in Adults With Type 2 Diabetes Mellitus
Led by Eli Lilly and Company · Updated on 2026-03-03
95
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults with Type 2 Diabetes Mellitus to compare the effects of the drug retatrutide with placebo on insulin secretion and insulin sensitivity. The study focuses on measuring changes in the total clamp disposition index after 28 weeks of treatment to better understand how retatrutide may affect diabetes management. The trial is a Phase 1, double-blind, randomized study sponsored by Eli Lilly and Company. Participants will be assigned randomly to receive one of three treatments: retatrutide, semaglutide, or placebo, all given by subcutaneous injection. The study treatments will be administered during the 28-week treatment period. Researchers will evaluate not only the primary outcome but also several secondary measures related to insulin secretion phases, glucose sensitivity, and response to meals. Throughout the study, participants will undergo various assessments including blood sampling to monitor insulin and glucose levels, clamp tests to evaluate insulin sensitivity, and standardized meal tests. Safety and laboratory tests will be regularly conducted. The main measurement will be taken at baseline and after 28 weeks to assess treatment effects. The total study duration for participants is approximately 28 weeks of treatment followed by monitoring.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Diagnosed with Type 2 Diabetes Mellitus for at least 6 months prior to screening
- Treated with diet, exercise, and metformin daily, with or without allowed oral antihyperglycaemia medications, for 3 months prior to 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 with other allowed medications requiring washout
- Venous access sufficient for blood sampling
- Clinical laboratory tests within normal range or with acceptable deviations
- Body mass index (BMI) between 25 and 45 kg/m² at screening
- Stable body weight with less than 5% change during the 3 months prior to screening
You will not qualify if you...
- Diagnosis of Type 1 Diabetes Mellitus
- More than 1 severe hypoglycaemia episode within 6 months before screening or history of hypoglycaemia unawareness
- One or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within 6 months prior to screening
- Current or planned treatment for diabetic retinopathy requiring injections, laser surgery, or vitrectomy
- Impaired kidney function with eGFR less than 60 mL/min/1.73 m²
- Acute or chronic pancreatitis or history of idiopathic pancreatitis
- Elevated liver enzymes or bilirubin beyond specified limits
- Evidence of hepatitis B or positive hepatitis C antibody without negative RNA confirmation
- Known gastric emptying problems or prior bariatric surgery
- Recent history (within 3 months) of heart attack, severe heart failure, stroke, coronary revascularization, or hospitalization for heart conditions
- Risk factors for Torsades de Pointes or ECG abnormalities increasing study risk
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2
- Active or untreated cancer or remission less than 5 years except specific skin or cervical cancers
- Significant uncontrolled endocrine disorders
- Prior or planned surgical or device-based obesity treatments
- Use of glucose-lowering medications other than allowed ones within 3 months prior to screening
- Use of weight loss medications or supplements within 3 months prior to screening
- Evidence of HIV infection or positive HIV antibodies
- Elevated calcitonin level above specified threshold
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 weeks
Participants receive Retatrutide, Semaglutide, or placebo administered by subcutaneous injection to evaluate effects on insulin secretion and sensitivity.
Regular visits during treatment period
Trial Site Locations
Total: 1 location
1
Profil Institut für Stoffwechselforschung
Neuss, Germany, 41460
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please 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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