Actively Recruiting
A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus
Led by Amgen · Updated on 2026-05-18
57
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of maridebart cafraglutide compared to a placebo on insulin sensitivity in adults with Type 2 Diabetes Mellitus (T2DM) who are already taking a stable dose of metformin. This Phase 1, randomized, double-blind, placebo-controlled trial aims to understand how this drug affects insulin sensitivity and beta-cell function, which are crucial in managing T2DM. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The treatment period lasts 25 weeks, during which changes in insulin sensitivity and beta-cell function will be monitored. The study includes a follow-up period up to 41 weeks to assess safety and other secondary measures. Throughout the study, participants will undergo various assessments including hyperinsulinemic-euglycemic and hyperglycemic clamps to measure insulin sensitivity and secretion, blood tests for glucose and lipid levels, body composition measurements, and appetite evaluations using visual analog scales. Researchers will monitor for adverse events and antibody formation. The total duration of participation covers treatment and follow-up visits to thoroughly evaluate the drug's effects and safety.
CONDITIONS
Brief Title
A Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent before starting any study activities or procedures
- Male or female aged 18 to 70 years at the time of consent
- Body mass index (BMI) ≥ 23.0 kg/m² for Asian participants or between 25 and 45 kg/m² for others at screening
- Diagnosed with Type 2 Diabetes Mellitus at least 6 months before screening based on WHO classification
- Treated for Type 2 Diabetes Mellitus for at least 3 months prior with diet, exercise, and a stable dose of metformin, with or without one additional oral antidiabetic medication besides metformin
You will not qualify if you...
- Type 1 diabetes mellitus or other types of diabetes except Type 2 or history of gestational diabetes
- History of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy requiring acute treatment
- Severe hypoglycemia episodes requiring help within 6 months before screening
- Modified diet or nutritional lifestyle changes within 3 months before screening
- History of malignancy within 5 years before screening except certain skin or cervical cancers
- Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- Endocrine disorders causing obesity like Cushing's syndrome
- Autoimmune diseases affecting insulin or glucose metabolism
- Recent major cardiovascular events or severe heart failure
- History of chronic or recent acute pancreatitis
- Positive HIV test or evidence of hepatitis B or C infection
- Kidney function impairment with estimated glomerular filtration rate below 60 mL/min/1.73 m²
- Low hemoglobin levels at screening
- Use of weight loss medications or supplements within 90 days before randomization
- Recent systemic glucocorticoid therapy or medications causing weight gain
- Use of herbal supplements affecting insulin or glucose within 30 days before randomization
- Participation in another investigational drug or device study recently
- Women of childbearing potential not adhering to contraception requirements
- Breastfeeding or planning pregnancy during and shortly after the study
- Planned major surgery during the study
- Known sensitivity to study products
- Likely inability to complete study visits or comply with procedures
- Other significant medical conditions posing safety risks or interfering with study participation as judged by the investigator or medical monitor
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.
1 visit (in-person)
Duration - 25 weeks
Participants receive maridebart cafraglutide or placebo administered subcutaneously to evaluate effects on insulin sensitivity and β-cell function.
Visits at baseline and Week 25 for assessments
Duration - Up to 16 weeks after treatment
Participants are monitored for treatment-emergent adverse events and antibody formation up to 41 weeks after starting treatment.
Periodic visits up to Week 41
Trial Site Locations
Total: 1 location
1
ProSciento, Inc. - Main Clinic
Chula Vista, California, United States, 91911-1350
Actively Recruiting
Research Team
A
Amgen Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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