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

Phase 3

Recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
• Interventions: Drug: Maridebart cafraglutide; Drug: Placebo

• Registration Number: NCT06858878
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-28
• Study First Submitted QC: 2025-02-28
• Study First Posted: 2025-03-05
• Study Start: 2025-03-17
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-26
• Primary Completion: 2027-01-21
• Study Completion: 2027-04-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 999

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maridebart Cafraglutide High Dose	Maridebart cafraglutide	Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.
Maridebart Cafraglutide Medium Dose	Maridebart cafraglutide	Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.
Maridebart Cafraglutide Low Dose	Maridebart cafraglutide	Participants will receive maridebart cafraglutide low dose SC for 72 weeks.
Placebo	Placebo	Participants will receive placebo SC for 72 weeks.

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Weight at Week 72	Baseline and Week 72

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Waist Circumference at Week 72	Baseline and Week 72
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
Participant achieving HbA1c < 5.7%, at week 72	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

Trial Locations

Locations (158)

Alliance for Multispecialty Research Mobile; 🇺🇸 Mobile, Alabama, United States

Gilbert Center for Family Medicine; 🇺🇸 Gilbert, Arizona, United States

Desert Clinical Research; 🇺🇸 Mesa, Arizona, United States

Avacare Foothills Research Center; 🇺🇸 Phoenix, Arizona, United States

San Fernando Valley Health Institute; 🇺🇸 Canoga Park, California, United States

Core Healthcare Group; 🇺🇸 Cerritos, California, United States

Velocity Clinical Research Chula Vista; 🇺🇸 Chula Vista, California, United States

Headlands Research California; 🇺🇸 Escondido, California, United States

Paradigm Clinical Research; 🇺🇸 Modesto, California, United States

Flourish Research; 🇺🇸 Northridge, California, United States

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