Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Obesity, AMG 133, T2DM, Hemoglobin A1C (HbA1c)
Brief summary
The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.
Interventions
Solution for subcutaneous injection.
DRUGPlacebo
Solution for subcutaneous injection.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) | Baseline to Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Austria, Greece, Hong Kong, Hungary, Italy, Japan, Poland, Puerto Rico, Romania, South Korea, Spain, Sweden, Taiwan, United States
Outcome results
None listed