Obesity
Conditions
Keywords
Overweight, BMI, Body weight, Maridebart cafraglutide, Chronic weight management, MariTide
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 administered SC.
DRUGPlacebo
Placebo will be administered 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 ≥ 30 kg/m2 or ≥27 kg/m² to \< 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH). * History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
Exclusion criteria
* Type 1 or Typ2 diabetes mellitus. * Obesity induced by other endocrinologic disorders. * Self-reported change in body weight \> 5 kg within 90 days before screening. * 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 | Description |
|---|---|---|
| Participant achieving ≥ 5% reduction in body weight from baseline at week 72 | Week 72 | — |
| Participant achieving ≥ 10% reduction in body weight from baseline at week 72 | Week 72 | — |
| Participant achieving ≥ 15% reduction in body weight from baseline at week 72 | Week 72 | — |
| Participant achieving ≥ 20% reduction in body weight from baseline at week 72 | 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 Glucose at Week 72 | Baseline and 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 | The IWQOL-Lite-CT is a 20-item questionnaire designed to assess the impact of weight on quality of life in clinical trials. Items are scored on a 5-point Likert scale, with raw scores transformed to a 0-100 scale, where higher scores indicate better quality of life and less weight-related impact. |
| Change From Baseline in Body Weight at Week 72 | Baseline and Week 72 | — |
| Change From Baseline in Waist Circumference at Week 72 | Baseline and Week 72 | — |
| Change From Baseline in Hemoglobin A1c at Week 72 | Baseline and Week 72 | — |
| Percent Change From Baseline in Fasting Insulin at Week 72 | Baseline and Week 72 | — |
| Change From Baseline in Glycemic Status at Week 72 | Baseline and Week 72 | — |
| Percent Change From Baseline in Fasting Lipid Parameters at Week 72 | Baseline and Week 72 | Lipid parameters include: total cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), and high-density lipoprotein cholesterol (HDL-C). |
| Change From Baseline in Diastolic Blood Pressure (DBP) 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 Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72 | Baseline and Week 72 | The SF-36v2 Acute Physical Function domain score measures an individual's ability to perform daily physical activities, such as walking and climbing stairs, over the past week. It includes 10 items scored on a 3-point Likert scale, with raw scores transformed to a 0-100 scale. Higher scores indicate better physical functioning and fewer limitations due to physical health. |
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Up to approximately 88 weeks | — |
| Plasma Concentration of Maridebart Cafraglutide at Week 72 | Week 72 | — |
| Change From Baseline in Body Mass Index (BMI) at Week 72 | Baseline and Week 72 | — |
Countries
Argentina, Australia, Belgium, Canada, Czechia, Denmark, Finland, Germany, Italy, Japan, Poland, Puerto Rico, South Korea, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed