Actively Recruiting
A 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 2025-12-01
70
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to determine the effect of maridebart cafraglutide relative to placebo on insulin sensitivity in participants with Type 2 Diabetes Mellitus (T2DM) treated with stable dose of metformin.
CONDITIONS
Official 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...
- Provided informed consent before any study procedures
- Male or female aged 18 to 70 years at consent
- Body mass index between 27 and 45 kg/m² at screening
- Diagnosed with Type 2 Diabetes Mellitus at least 6 months before screening
- Treated for Type 2 Diabetes Mellitus for at least 3 months with diet, exercise, and a stable dose of metformin, with or without one additional oral antidiabetic medication
You will not qualify if you...
- Type 1 diabetes, history of ketoacidosis or hyperosmolar coma, or other diabetes types except T2DM or gestational diabetes history
- History of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative retinopathy requiring acute treatment
- Severe hypoglycemia episodes needing assistance within 6 months before screening
- Modified diet or nutritional lifestyle changes within 3 months prior to screening
- History of malignancy within 5 years except certain skin and cervical or breast cancers
- Family or personal history of medullary thyroid carcinoma or MEN-2 syndrome
- Endocrine disorders causing obesity
- Autoimmune diseases affecting insulin or glucose metabolism
- Major cardiovascular events or surgeries within 90 days before screening or severe heart failure
- History of chronic or recent acute pancreatitis
- Positive HIV test or hepatitis B or C infection
- Kidney function estimated glomerular filtration rate below 60 mL/min/1.73 m²
- Low hemoglobin levels below 12 g/dL in males or 10 g/dL in females
- Use of weight loss drugs, systemic steroids, medications causing weight gain, or herbal supplements affecting insulin/glucose within defined prior periods
- Participation in other investigational studies recently
- Women unwilling or unable to follow contraception requirements or who are breastfeeding or planning pregnancy during and 16 weeks after treatment
- Planned major surgery during the study
- Known sensitivity to study products
- Likely inability to complete study visits or procedures
- Any other significant medical condition posing safety risk or interfering with study as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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