Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Conditions
Keywords
Type 2 Diabetes Mellitus, T2DM, Obesity, Overweight, Maridebart Cafraglutide, AMG 133, MariTide, Chronic Weight Management
Brief summary
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
Interventions
Maridebart cafraglutide will be adminstered SC.
DRUGPlacebo
Placebo will be adminstered SC.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Body mass index ≥ 27 kg/m\^2. * History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise. * Diagnosis of T2DM.
Exclusion criteria
* Type 1 diabetes mellitus. * Self-reported change in body weight \> 5 kg within 90 days before screening. * Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment. * Obesity induced by other endocrinologic disorders. * Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2. * History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening. * History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening. * Lifetime history of suicide attempt.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight at Week 72 | Baseline and Week 72 |
Secondary
| Measure | Time frame |
|---|---|
| Participant achieving ≥ 5% reduction in body weight from baseline at week 72 | Baseline and Week 72 |
| Participant achieving ≥ 10% reduction in body weight from baseline at week 72 | Baseline and Week 72 |
| Participant achieving ≥ 15% reduction in body weight from baseline at week 72 | Baseline and Week 72 |
| Change from Baseline in Systolic Blood Pressure (SBP) at Week 72 | Baseline and Week 72 |
| Percent Change from Baseline in Fasting Triglycerides at Week 72 | Baseline and Week 72 |
| Change from Baseline in Fasting Plasma Glucose at Week 72 | Baseline and Week 72 |
| Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72 | Baseline and Week 72 |
| Participant achieving HbA1c < 7% at week 72 | Week 72 |
| Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72 | Baseline and Week 72 |
| Change from Baseline in Body Weight at Week 72 | Baseline and Week 72 |
| Participant achieving ≥ 20% reduction in body weight from baseline at week 72 | Baseline and Week 72 |
| Change from Baseline in Body Mass Index (BMI) at Week 72 | Baseline and Week 72 |
| Participant achieving HbA1c ≤ 6.5% at week 72 | Week 72 |
| Change from Baseline in Waist Circumference at Week 72 | Baseline and Week 72 |
| Percent Change from Baseline in Fasting Insulin at Week 72 | Baseline and Week 72 |
| Percent Change from Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72 | Baseline and Week 72 |
| Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72 | Baseline and Week 72 |
| Percent Change from Baseline at Week 72 in Fasting Concentration of Total Cholesterol | Baseline and Week 72 |
| Percent Change from Baseline at Week 72 in Fasting Concentration of Non-high-density Lipoprotein Cholesterol (non-HDL-C) | Baseline and Week 72 |
| Percent Change from Baseline at Week 72 in Fasting Concentration of Low-density Lipoprotein Cholesterol (LDL-C) | Baseline and Week 72 |
| Percent Change from Baseline at Week 72 in Fasting Concentration of Very-low-density Lipoprotein Cholesterol (VLDL-C) | Baseline and Week 72 |
| Percent Change from Baseline at Week 72 in Fasting Concentration of High-density Lipoprotein Cholesterol (HDL-C) | Baseline and Week 72 |
| Change from Baseline in Diastolic Blood Pressure DBP at Week 72 | Baseline and Week 72 |
| Change from Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72 | Baseline and Week 72 |
| Number of Participants who Experienced Treatment-emergent Adverse Events | Up to Week 84 |
| Number of Participants who Experienced Serious Adverse Events | Up to Week 84 |
| Plasma Concentration of Maridebart Cafraglutide at Week 72 | Week 72 |
| Participant achieving HbA1c < 5.7%, at week 72 | Week 72 |
Countries
Argentina, Bulgaria, Canada, Czechia, Germany, Hungary, Italy, Japan, Poland, Puerto Rico, South Korea, United Kingdom, United States
Outcome results
None listed