Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Phase 3Active Not RecruitingNCT06858839

Amgen3,853 enrolled

Overview

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

3,853

Conditions

Obesity

Interventions

Maridebart CafraglutideDRUG

Maridebart cafraglutide will be administered SC.

PlaceboDRUG

Placebo will be administered SC.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (243)

Outcomes

Primary Outcomes

Percent Change From Baseline in Body Weight at Week 72

Time frame: Baseline and Week 72

Secondary Outcomes

Change From Baseline in Waist Circumference at Week 72

Time frame: Baseline and Week 72

Participant achieving ≥ 5% reduction in body weight from baseline at week 72

Time frame: Week 72

Participant achieving ≥ 10% reduction in body weight from baseline at week 72

Time frame: Week 72

Participant achieving ≥ 15% reduction in body weight from baseline at week 72

Time frame: Week 72

Participant achieving ≥ 20% reduction in body weight from baseline at week 72

Time frame: Week 72

Change From Baseline in Systolic Blood Pressure (SBP) at Week 72

Time frame: Baseline and Week 72

Percent Change From Baseline in Fasting Triglycerides at Week 72

Time frame: Baseline and Week 72

Change From Baseline in Fasting Glucose at Week 72

Time frame: 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

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.

Data from ClinicalTrials.gov

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Pinnacle Research Group LLC

Anniston, Alabama, United States

Alliance For Multispecialty Research - Daphne

Daphne, Alabama, United States

Alliance for Multispecialty Research Mobile

Mobile, Alabama, United States

Avacare Foothills Research Center

Phoenix, Arizona, United States

Ark Clinical Research- Tustin

Fountain Valley, California, United States

Long Beach Clinical Trials Services Inc

Long Beach, California, United States

Ark Clinical Research- Long Beach

Long Beach, California, United States

Catalina Research Institute

Montclair, California, United States

Artemis Institute for Clinical Research

Riverside, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

...and 233 more locations

Time frame: Baseline and Week 72

Change From Baseline in Body Weight at Week 72

Time frame: Baseline and Week 72

Change From Baseline in Body Mass Index (BMI) at Week 72

Time frame: Baseline and Week 72

Change From Baseline in Hemoglobin A1c at Week 72

Time frame: Baseline and Week 72

Percent Change From Baseline in Fasting Insulin at Week 72

Time frame: Baseline and Week 72

Change From Baseline in Glycemic Status at Week 72

Time frame: Baseline and Week 72

Percent Change From Baseline in Fasting Lipid Parameters at 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).

Time frame: Baseline and Week 72

Change From Baseline in Diastolic Blood Pressure (DBP) at Week 72

Time frame: Baseline and Week 72

Percent Change From Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72

Time frame: 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

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.

Time frame: Baseline and Week 72

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Time frame: Up to approximately 88 weeks

Plasma Concentration of Maridebart Cafraglutide at Week 72

Time frame: Week 72