A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)
Phase 2
Active, not recruiting
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Interventions
- Drug: Placebo
- Registration Number
- NCT06660173
- Lead Sponsor
- Amgen
- Brief Summary
The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 409
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maridebart Cafraglutide Maridebart Cafraglutide Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week main treatment period and meet specific criteria will have the option to begin an exploratory part 2 portion where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks. Placebo Placebo Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week main treatment period and meet specific criteria will have the option to begin an exploratory part 2 period where they will receive maridebart cafraglutide for an additional 24 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) Baseline to Week 24
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline to Week 24 in Body Weight Baseline to Week 24 Number of Participants Achieving HbA1c < 7.0% at Week 24 Week 24 Number of Participants Achieving HbA1c ≤ 6.5% at Week 24 Week 24 Number of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 24 Week 24 Number of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 24 Week 24 Change From Baseline to Week 24 in Fasting Glucose Baseline to Week 24 Percent Change From Baseline to Week 24 in Total Cholesterol Baseline to Week 24 Percent Change From Baseline to Week 24 in Low-density Lipoprotein Cholesterol (LDL-C) Baseline to Week 24 Percent Change From Baseline to Week 24 in High-density Lipoprotein Cholesterol (HDL-C) Baseline to Week 24 Percent Change From Baseline to Week 24 in Non-high Density Lipoprotein Cholesterol (non-HDL-C) Baseline to Week 24 Percent Change From Baseline to Week 24 in Very-low-density Lipoprotein Cholesterol (VLDL-C) Baseline to Week 24 Percent Change From Baseline to Week 24 in Triglycerides Baseline to Week 24 Percent Change From Baseline to Week 24 in Free Fatty Acids (FFA) Baseline and Week 24 Change From Baseline to Week 24 in Systolic Blood Pressure Baseline and Week 24 Change From Baseline to Week 24 in Diastolic Blood Pressure Baseline and Week 24 Change from Baseline to Week 24 in High-sensitivity C-reactive Protein Baseline and Week 24 Pre-dose Plasma Concentration of Maridebart Cafraglutide at Week 20 Week 20 Maximum Observed Plasma Concentration of Maridebart Cafraglutide at Week 20 Week 20 Number of Participants with Treatment Emergent Adverse Events Up to 24 Weeks Number of Participants with Serious Adverse Events Up to 24 Weeks Number of Participants with Anti-maridebart Cafraglutide Antibody Formation Up to Week 24
Trial Locations
- Locations (95)
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
Scroll for more (85 remaining)Accel Research Site - Birmingham Clinical Research Unit🇺🇸Birmingham, Alabama, United States