Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Phase 3Active Not RecruitingNCT06858878

Amgen1,105 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

1,105

Conditions

Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Interventions

Maridebart cafraglutideDRUG

Maridebart cafraglutide will be adminstered SC.

PlaceboDRUG

Placebo will be adminstered SC.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (187)

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: Baseline and Week 72

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

Time frame: Baseline and Week 72

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

Time frame: Baseline and 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 Plasma Glucose at Week 72

Time frame: Baseline and Week 72

Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72

Time frame: Baseline and Week 72

Participant achieving HbA1c < 7% at week 72

Time frame: 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

Data from ClinicalTrials.gov

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...and 177 more locations

Time frame: Baseline and Week 72

Change from Baseline in Body Weight at Week 72

Time frame: Baseline and Week 72

Participant achieving ≥ 20% reduction in body weight from baseline 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

Participant achieving HbA1c ≤ 6.5% at week 72

Time frame: Week 72

Participant achieving HbA1c < 5.7%, at week 72

Time frame: Week 72

Percent Change from Baseline in Fasting Insulin 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 Urine Albumin-to-creatinine Ratio (uACR) at Week 72

Time frame: Baseline and Week 72

Percent Change from Baseline at Week 72 in Fasting Concentration of Total Cholesterol

Time frame: Baseline and Week 72

Percent Change from Baseline at Week 72 in Fasting Concentration of Non-high-density Lipoprotein Cholesterol (non-HDL-C)

Time frame: Baseline and Week 72

Percent Change from Baseline at Week 72 in Fasting Concentration of Low-density Lipoprotein Cholesterol (LDL-C)

Time frame: Baseline and Week 72

Percent Change from Baseline at Week 72 in Fasting Concentration of Very-low-density Lipoprotein Cholesterol (VLDL-C)

Time frame: Baseline and Week 72

Percent Change from Baseline at Week 72 in Fasting Concentration of 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

Change from Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72

Time frame: Baseline and Week 72

Number of Participants who Experienced Treatment-emergent Adverse Events

Time frame: Up to Week 84

Number of Participants who Experienced Serious Adverse Events

Time frame: Up to Week 84

Plasma Concentration of Maridebart Cafraglutide at Week 72

Time frame: Week 72