Clinical trial NCT06858878: Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Keywords: Type 2 Diabetes Mellitus
T2DM
Obesity
Overweight
Maridebart Cafraglutide
AMG 133
MariTide
Chronic Weight Management
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2025-03-05
Enrollment: 999
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change from Baseline in Body Weight at Week 72
timeFrame: Baseline and Week 72
Secondary outcomes:
measure: Change from Baseline in Waist Circumference at Week 72
timeFrame: Baseline and Week 72
measure: Participant achieving ≥ 5% reduction in body weight from baseline at week 72
timeFrame: Baseline and Week 72
measure: Participant achieving ≥ 10% reduction in body weight from baseline at week 72
timeFrame: Baseline and Week 72
measure: Participant achieving ≥ 15% reduction in body weight from baseline at week 72
timeFrame: Baseline and Week 72
measure: Change from Baseline in Systolic Blood Pressure (SBP) at Week 72
timeFrame: Baseline and Week 72
measure: Percent Change from Baseline in Fasting Triglycerides at Week 72
timeFrame: Baseline and Week 72
measure: Change from Baseline in Fasting Plasma Glucose at Week 72
timeFrame: Baseline and Week 72
measure: Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72
timeFrame: Baseline and Week 72
measure: Participant achieving HbA1c < 7% at week 72
timeFrame: Week 72
measure: 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
timeFrame: Baseline and Week 72
measure: Change from Baseline in Body Weight at Week 72
timeFrame: Baseline and Week 72
measure: Participant achieving ≥ 20% reduction in body weight from baseline at week 72
timeFrame: Baseline and Week 72
measure: Change from Baseline in Body Mass Index (BMI) at Week 72
timeFrame: Baseline and Week 72
measure: Participant achieving HbA1c ≤ 6.5% at week 72
timeFrame: Week 72
measure: Participant achieving HbA1c < 5.7%, at week 72
timeFrame: Week 72
measure: Percent Change from Baseline in Fasting Insulin at Week 72
timeFrame: Baseline and Week 72
measure: Percent Change from Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72
timeFrame: Baseline and Week 72
measure: Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72
timeFrame: Baseline and Week 72
measure: Percent Change from Baseline at Week 72 in Fasting Concentration of Total Cholesterol
timeFrame: Baseline and Week 72
measure: Percent Change from Baseline at Week 72 in Fasting Concentration of Non-high-density Lipoprotein Cholesterol (non-HDL-C)
timeFrame: Baseline and Week 72
measure: Percent Change from Baseline at Week 72 in Fasting Concentration of Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline and Week 72
measure: Percent Change from Baseline at Week 72 in Fasting Concentration of Very-low-density Lipoprotein Cholesterol (VLDL-C)
timeFrame: Baseline and Week 72
measure: Percent Change from Baseline at Week 72 in Fasting Concentration of High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline and Week 72
measure: Change from Baseline in Diastolic Blood Pressure DBP at Week 72
timeFrame: Baseline and Week 72
measure: Change from Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72
timeFrame: Baseline and Week 72
measure: Number of Participants who Experienced Treatment-emergent Adverse Events
timeFrame: Up to Week 84
measure: Number of Participants who Experienced Serious Adverse Events
timeFrame: Up to Week 84
measure: Plasma Concentration of Maridebart Cafraglutide at Week 72
timeFrame: Week 72
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Alliance for Multispecialty Research Mobile
state: Alabama
city: Gilbert
country: United States
facility: Gilbert Center for Family Medicine
state: Arizona
city: Mesa
country: United States
facility: Desert Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Avacare Foothills Research Center
state: Arizona
city: Canoga Park
country: United States
facility: San Fernando Valley Health Institute
state: California
city: Cerritos
country: United States
facility: Core Healthcare Group
state: California
city: Chula Vista
country: United States
facility: Velocity Clinical Research Chula Vista
state: California
city: Escondido
country: United States
facility: Headlands Research California
state: California
city: Modesto
country: United States
facility: Paradigm Clinical Research
state: California
city: Northridge
country: United States
facility: Flourish Research
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: San Diego
country: United States
facility: Infinity Clinical Trials
state: California
city: Riverside
country: United States
facility: Greenwich Clinical Trials
state: Connecticut
city: Hialeah
country: United States
facility: Indago Research and Health Center
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic Inc
state: Florida
city: Miami
country: United States
facility: Optimus U Corporation
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Orlando
country: United States
facility: Florida Institute for Clinical Research
state: Florida
city: Weston
country: United States
facility: Encore Medical Research of Weston LLC
state: Florida
city: Winter Park
country: United States
facility: Conquest Research - Winter Park
state: Florida
city: Oak Brook
country: United States
facility: Alliance For Multispecialty Research - Oak Brook
state: Illinois
city: Park Ridge
country: United States
facility: Alliance for Multispecialty Research, LLC - Park Ridge
state: Illinois
city: Skokie
country: United States
facility: Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie
state: Illinois
city: Merrillville
country: United States
facility: Indiana Medical Research Institute
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Diabetes Research
state: Iowa
city: Newton
country: United States
facility: Alliance for Multispecialty Research Newton
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research LLC
state: Kansas
city: Paducah
country: United States
facility: Advanced Internal Medicine
state: Kentucky
city: Monroe
country: United States
facility: Ima Clinical Research- Monroe
state: Louisiana
city: Annapolis
country: United States
facility: Annapolis Internal Medicine, LLC
state: Maryland
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: International Diabetes Center - HealthPartners Institute
state: Minnesota
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research - Kansas City
state: Missouri
city: Las Vegas
country: United States
facility: Palm Research Center Inc
state: Nevada
city: Sparks
country: United States
facility: Vector Clinical Trials
state: Nevada
city: Trenton
country: United States
facility: Premier Research
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Asheville
country: United States
facility: Asheville Clinical Research
state: North Carolina
city: Greenville
country: United States
facility: Physicians East
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Morehead City
country: United States
facility: West Clinical Research
state: North Carolina
city: Blue Ash
country: United States
facility: Velocity Clinical Research - Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research - Springdale
state: Ohio
city: East Greenwich
country: United States
facility: Velocity Clinical Research - Providence
state: Rhode Island
city: Elizabethton
country: United States
facility: Medical Care LLC
state: Tennessee
city: Austin
country: United States
facility: Elligo Clinical Research Center
state: Texas
city: Corpus Christi
country: United States
facility: Osvaldo A Brusco MD PA
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research, LLC
state: Texas
city: Denison
country: United States
facility: Soma Clinical Trials, LLC
state: Texas
city: Euless
country: United States
facility: Cedar Health Research, LLC
state: Texas
city: Houston
country: United States
facility: Juno Research LLC
state: Texas
city: Houston
country: United States
facility: Juno Research LLC
state: Texas
city: McKinney
country: United States
facility: Tekton Research
state: Texas
city: San Antonio
country: United States
facility: Northeast Clinical Research of San Antonio LLC
state: Texas
city: Layton
country: United States
facility: Alliance for Multispecialty Research - Layton
state: Utah
city: Manassas
country: United States
facility: Manassas Clinical Research Center Inc
state: Virginia
city: Morgantown
country: United States
facility: Ima Clinical Research - West Virginia
state: West Virginia
city: Surrey
country: Canada
facility: tlc Diabetes and Endocrinology
state: British Columbia
city: Concord
country: Canada
facility: Centricity Research Vaughan
state: Ontario
city: Hamilton
country: Canada
facility: Premier Clinical Trial Network
state: Ontario
city: Niagara Falls
country: Canada
facility: Your Research Network Inc.
state: Ontario
city: North York
country: Canada
facility: North York Diagnostic and Cardiac Centre
state: Ontario
city: Pointe-Claire
country: Canada
facility: Centricity Research Pointe-Claire
state: Quebec
city: Matsuyama-shi
country: Japan
facility: Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
state: Ehime
city: Kitakyusyu-shi
country: Japan
facility: Morizono Medical Clinic
state: Fukuoka
city: Aki-gun
country: Japan
facility: Mazda Hospital of Mazda Motor Corporation
state: Hiroshima
city: Mito-shi
country: Japan
facility: Nakamoto Medical Clinic
state: Ibaraki
city: Naka-shi
country: Japan
facility: Nakakinen Clinic
state: Ibaraki
city: Tsuchiura-shi
country: Japan
facility: Ohishi Naika Clinic
state: Ibaraki
city: Kumamoto-shi
country: Japan
facility: Morinaga Ueno Clinic
state: Kumamoto
city: Kashiwara-shi
country: Japan
facility: Shiraiwa Medical Clinic
state: Osaka
city: Shizuoka-shi
country: Japan
facility: Suruga Clinic
state: Shizuoka
city: Meguro-ku
country: Japan
facility: Yutenji Medical Clinic
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Medical Corporation Ouitsukai Kanno Naika
state: Tokyo
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: Belfast
country: United Kingdom
facility: Ormeau Clinical Trials Ltd
city: Birmingham
country: United Kingdom
facility: FutureMeds Birmingham
city: Blackpool
country: United Kingdom
facility: Layton Medical Centre
city: Blackpool
country: United Kingdom
facility: Waterloo Medical Centre
city: Ely
country: United Kingdom
facility: Staploe Medical Centre
city: Glasgow
country: United Kingdom
facility: FutureMeds Glasgow
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: