DRUG
Maridebart cafraglutide
Maridebart cafraglutide will be administered SC.
Status
Active, not recruiting
Phase
Phase 1
Enrollment
56
Locations
1
Results
Not posted
Publications
0
Study summary
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.
Interventions
DRUG
Maridebart cafraglutide will be administered SC.
DRUG
Placebo will be administered SC.
Timeline
First posted
Sep 8, 2025
Study start
Aug 5, 2025
Primary completion
Nov 15, 2026
Study completion
Mar 4, 2027
Results posted
Not reported
Registry updated
Jun 12, 2026
Outcomes
Change from Baseline in M-value from Hyperinsulinemic-euglycemic Clamp at Week 25
Time frame · Baseline and Week 25
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Time frame · Up to Week 41
Plasma Concentration of Maridebart Cafraglutide at Week 25
Time frame · Week 25
Number of Participants with Anti-maridebart Cafraglutide Antibody Formation
Time frame · Up to Week 41
Change from Baseline in Total Insulin Secretion at Week 25
Time frame · Baseline and Week 25
Measured as area under the curve (AUC) of insulin secretion rate (ISR) from hyperglycemic clamp (ISR0-120min).
Change from Baseline in First Phase Incremental ISR from Hyperglycemic Clamp (ISR0-8min) at Week 25
Time frame · Baseline and Week 25
Change from Baseline in Second Phase Insulin Secretion at Week 25
Time frame · Baseline and Week 25
Measured as AUC of ISR from hyperglycemic clamp (ISR20-120min).
Change from Baseline in Maximum Insulin Secretion at 8 Minutes at Week 25
Time frame · Baseline and Week 25
Measured as incremental ISR responses to arginine from hyperglycemic clamp at 8 minutes (ISRarg0-8min).
Change from Baseline in Maximum Insulin Secretion at 30 Minutes at Week 25
Time frame · Baseline and Week 25
Measured as incremental ISR responses to arginine from hyperglycemic clamp at 30 minutes (ISRarg0-30min).
Change from Baseline in ISR at Week 25
Time frame · Baseline and Week 25
Measured as total AUC (ISR0-240min) from standardized mixed meal tolerance test (sMMTT).
Change from Baseline in Clamp Disposition Index (cDI) at Week 25
Time frame · Baseline and Week 25
Calculated as product of M-value and ISR0-120min from the hyperglycemic clamp.
Eligibility
Inclusion Criteria: * 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 Criteria: * 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.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
ProSciento, Inc. - Main Clinic
Chula Vista, California, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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