Study of Maridebart Cafraglutide for Type 2 Diabetes Mellitus
This study is looking at how a drug called maridebart cafraglutide affects insulin sensitivity (how well your body uses insulin) and beta-cell function in people with Type 2 Diabetes Mellitus (T2DM). Participants will receive either maridebart cafraglutide or a placebo (an inactive substance) through injections under the skin. The main goal is to see if maridebart cafraglutide improves insulin sensitivity after 25 weeks. You might be able to join if you are between 18 and 70 years old, have T2DM, and meet certain body mass index (BMI) requirements. The study aims to enroll 56 participants.
- Study design
- This is an interventional study comparing maridebart cafraglutide to a placebo. It plans to enroll 56 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at Week 25, indicating follow-up for at least that duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07160257
A Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus
Active, Not Recruiting
PHASE1Ages 18–70InterventionalTreatmentAmgen
~56 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Maridebart cafraglutidePlacebo
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in M-value from Hyperinsulinemic-euglycemic Clamp at Week 25
Measured over Baseline and Week 25
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- MD · STUDY_DIRECTOR · Amgen
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Informed consent before initiation of any study-specific activities/procedures.
Male or female participants aged ≥ 18 and ≤ 70 years at the time of signing informed consent.
Body mass index ≥ 23.0 kg/m\^2 (Asian participants only) or ≥ 25 and ≤ 45 kg/m\^2 at screening.
Diagnosis of T2DM at least 6 months before screening based on the WHO classification.
Treatment of T2DM for at least 3 months prior to screening with diet and exercise and a stable dose of metformin (either immediate release or extended release), with or without a stable dose of 1 additional OAM other than metformin.
Exclusion
Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus (except T2DM or history of gestational diabetes).
History of proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment.
One or more episodes of severe hypoglycemia (Level 3 hypoglycemia as defined by the American Diabetes Association classification criteria) within 6 months before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery.
Has modified diet or adopted any nutritional lifestyle modifications within 3 months prior to screening, as assessed by the investigator (or designee) based on participant self-report.
History of malignancy within the last 5 years before screening (except nonmelanoma skin cancers, cervical carcinoma in situ, or breast ductal carcinoma in situ).
Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2).
History or evidence of endocrine disorder (such as Cushing's syndrome) that can cause obesity.
History or evidence of autoimmune disease that can directly or indirectly affect insulin production, insulin action, or glucose metabolism.
History of any of the following within 90 days before screening: myocardial infarction, unstable angina, coronary artery bypass graft surgery or other major cardiovascular surgery, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure, or currently have New York Heart Association Class III or IV heart failure.
History of chronic pancreatitis.
History of acute pancreatitis within 6 months before screening.
Positive human immunodeficiency virus test at screening.
Evidence of hepatitis B or C infection.
Estimated glomerular filtration rate \< 60 mL/min/1.73 m\^2 calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine-cystatin C equation at screening.
Hemoglobin value \< 12 g/dL (males) or \< 10 g/dL (females) at screening or check-in (Day -4).
Use within 90 days before randomization of medications, supplements, or alternative remedies for weight loss (eg, GLP-1RA, GIP agonists, phentermine/topiramate, naltrexone/bupropion, orlistat, and sympathomimetic drugs).
Use within 90 days before randomization of chronic (\> 14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intraarticular, or inhaled preparations).
Use within 90 days before randomization of medications that may cause significant weight gain including, but not limited to, atypical antipsychotic and mood stabilizers.
Current or prior use of herbal supplements that affect insulin or glucose within 30 days before randomization.
Currently receiving treatment in another investigational device or drug study, or less than 30 days (or 5 half-lives, whichever is longer) since ending treatment on another investigational device or drug study(ies).
Participants of childbearing potential unwilling to adhere to contraception requirements during treatment and for an additional 16 weeks after the last dose of IMP.
Participants who are breastfeeding or who plan to breastfeed while on study through 16 weeks after the last dose of IMP.
Participants planning to become pregnant while on study through 16 weeks after the last dose of IMP.
Major surgical procedure planned during the study.
Participant has known sensitivity to any of the products or components to be administered during dosing.
Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the investigator or medical monitor, if consulted as necessary, would pose a risk to participant's safety or interfere with the study evaluation, procedures, or completion.
What this trial measures
- Change from Baseline in M-value from Hyperinsulinemic-euglycemic Clamp at Week 25Baseline and Week 25