DRUG
Maridebart Cafraglutide
Solution for subcutaneous injection.
Status
Active, not recruiting
Phase
Phase 2
Enrollment
409
Locations
96
Results
Not posted
Publications
0
Study summary
The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.
Interventions
DRUG
Solution for subcutaneous injection.
DRUG
Solution for subcutaneous injection.
Timeline
First posted
Oct 28, 2024
Study start
Nov 7, 2024
Primary completion
Oct 6, 2025
Study completion
Nov 10, 2026
Results posted
Not reported
Registry updated
Nov 25, 2025
Outcomes
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
Time frame · Baseline to Week 24
Percent Change From Baseline to Week 24 in Body Weight
Time frame · Baseline to Week 24
Number of Participants Achieving HbA1c < 7.0% at Week 24
Time frame · Week 24
Number of Participants Achieving HbA1c ≤ 6.5% at Week 24
Time frame · Week 24
Number of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 24
Time frame · Week 24
Number of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 24
Time frame · Week 24
Change From Baseline to Week 24 in Fasting Glucose
Time frame · Baseline to Week 24
Percent Change From Baseline to Week 24 in Total Cholesterol
Time frame · Baseline to Week 24
Percent Change From Baseline to Week 24 in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame · Baseline to Week 24
Percent Change From Baseline to Week 24 in High-density Lipoprotein Cholesterol (HDL-C)
Time frame · Baseline to Week 24
Percent Change From Baseline to Week 24 in Non-high Density Lipoprotein Cholesterol (non-HDL-C)
Time frame · Baseline to Week 24
Eligibility
Inclusion Criteria: * Age ≥ 18 years at screening (or ≥ legal age within the country if it is older than 18 years) * Type 2 diabetes for ≥6 months according to the World Health Organization classification * HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory * Treatment of diabetes with diet and exercise alone, or with a stable dose of metformin, with or without a sodium-glucose cotransporter-2 inhibitor, for at least 3 months prior to screening * Body mass index of 23 to 50 kilograms per square meter Exclusion Criteria: * Type 1 diabetes * Use of any glucose-lowering medication, other than metformin with or without a sodium-glucose cotransporter-2 inhibitor, within 3 months prior to screening * Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology equation. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy * History of acute or chronic pancreatitis * Malignancy within 5 years before screening, except for nonmelanoma skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer * Myocardial infarction, unstable angina, coronary artery bypass graft surgery or other major cardiovascular surgery, percutaneous coronary intervention, transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure within 90 days prior to screening, or currently have New York Heart Association Class III or IV heart failure. * Use of medications that affect glucose control or body weight or history of bariatric surgery or procedures.
Study locations
Austria · Greece · Hong Kong · Hungary · Italy · Japan · Poland · Puerto Rico · Romania · South Korea · Spain · Sweden · Taiwan · United States. Showing up to 24 locations stored in the fast local snapshot.
Accel Research Site - Birmingham Clinical Research Unit
Birmingham, Alabama, United States
Anaheim Clinical Trials
Anaheim, California, United States
Hope Clinical Research LLC
Canoga Park, California, United States
Orange County Research Center
Lake Forest, California, United States
San Jose Clinical Trials
San Jose, California, United States
Northeast Research Institute - Neri
Fleming Island, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Florida Institute for Clinical Research
Orlando, Florida, United States
Conquest Research - Winter Park
Winter Park, Florida, United States
Accel Research Site - Neurostudies
Decatur, Georgia, United States
Cedar Crosse Research and Health Care
Chicago, Illinois, United States
Tandem Clinical Research - Marrero
Marrero, Louisiana, United States
DM Clinical - Detroit
Southfield, Michigan, United States
Montana Medical Research
Missoula, Montana, United States
Physicians East
Greenville, North Carolina, United States
Diabetes and Endocrinology Associates of Stark County Inc
Canton, Ohio, United States
Alliance for Multispecialty Research
Norman, Oklahoma, United States
Trial Management Associates - Myrtle Beach
Myrtle Beach, South Carolina, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Velocity Clinical Research - Dallas
Dallas, Texas, United States
DM Clinical Research - Cyfair Clinical Research Center
Houston, Texas, United States
Southern Endocrinology Associates PA
Mesquite, Texas, United States
Be Well Clinical Studies
Round Rock, Texas, United States
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
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