Clinical trial NCT06858839: Evaluation of Maridebart Cafraglutide in Adult Participants Without 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 Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Obesity
Keywords: Overweight
BMI
Body weight
Maridebart cafraglutide
Chronic weight management
MariTide
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2025-03-05
Enrollment: 3501
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 ≥ 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.

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: Week 72
measure: Participant achieving ≥ 10% reduction in body weight from baseline at week 72
timeFrame: Week 72
measure: Participant achieving ≥ 15% reduction in body weight from baseline at week 72
timeFrame: Week 72
measure: Participant achieving ≥ 20% reduction in body weight from baseline at week 72
timeFrame: 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 Glucose at Week 72
timeFrame: Baseline and 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: Change From Baseline in Body Mass Index (BMI) at Week 72
timeFrame: Baseline and Week 72
measure: Change From Baseline in Hemoglobin A1c at Week 72
timeFrame: Baseline and Week 72
measure: Percent Change From Baseline in Fasting Insulin at Week 72
timeFrame: Baseline and Week 72
measure: Change From Baseline in Glycemic Status at Week 72
timeFrame: Baseline and Week 72
measure: Percent Change From Baseline in Fasting Lipid Parameters at Week 72
timeFrame: Baseline and Week 72
measure: Change From Baseline in Diastolic Blood Pressure (DBP) 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 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 Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 88 weeks
measure: Plasma Concentration of Maridebart Cafraglutide at Week 72
timeFrame: Week 72
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group LLC
state: Alabama
city: Daphne
country: United States
facility: Alliance For Multispecialty Research - Daphne
state: Alabama
city: Mobile
country: United States
facility: Alliance for Multispecialty Research Mobile
state: Alabama
city: Phoenix
country: United States
facility: Avacare Foothills Research Center
state: Arizona
city: Fountain Valley
country: United States
facility: Ark Clinical Research- Tustin
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials Services Inc
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research- Long Beach
state: California
city: Montclair
country: United States
facility: Catalina Research Institute
state: California
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Apex Clinical Research
state: California
city: Santa Ana
country: United States
facility: Southern California Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research LLC
state: Connecticut
city: Hialeah
country: United States
facility: Indago Research and Health Center
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions - Jacksonville
state: Florida
city: Margate
country: United States
facility: South Florida Wellness and Clinical Research Institute
state: Florida
city: Miami
country: United States
facility: Optimus U Corporation
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions - Orlando
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando Phase I IV
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: Gainesville
country: United States
facility: Center for Advanced Research and Education
state: Georgia
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research
state: Hawaii
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Flourish Research - Great Lakes Clinical Trials
state: Illinois
city: Skokie
country: United States
facility: Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie
state: Illinois
city: Skokie
country: United States
facility: Evanston Premier Healthcare Research LLC
state: Illinois
city: Newton
country: United States
facility: Alliance for Multispecialty Research Newton
state: Kansas
city: Louisville
country: United States
facility: Louisville Metabolic and Atherosclerosis Research Center
state: Kentucky
city: Baton Rouge
country: United States
facility: Velocity Clinical Research - Baton Rouge
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research - Marrero
state: Louisiana
city: Southfield
country: United States
facility: Headlands Research - Detroit
state: Michigan
city: Fayette
country: United States
facility: Prime Health and Wellness Sky Clinical Research Network Group
state: Mississippi
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: Las Vegas
country: United States
facility: Vector Clinical Trials
state: Nevada
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Vestal
country: United States
facility: Velocity Clinical Research - Vestal
state: New York
city: Hickory
country: United States
facility: Accellacare of Hickory
state: North Carolina
city: Shelby
country: United States
facility: Carolina Research Center Inc
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: Clinical Trial Investigator Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research - Cincinnati
state: Ohio
city: Norman
country: United States
facility: Alliance for Multispecialty Research - Norman
state: Oklahoma
city: Newport
country: United States
facility: Capital Area Research LLC
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research - Providence
state: Rhode Island
city: Greenville
country: United States
facility: Tribe Clinical Research LLC Dba Mountain View Clinical Research
state: South Carolina
city: Knoxville
country: United States
facility: New Phase Research and Development
state: Tennessee
city: Knoxville
country: United States
facility: Accellacare US Inc., d/b/a Accellacare of Knoxville
state: Tennessee
city: Austin
country: United States
facility: Elligo Clinical Research Center
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research, LLC
state: Texas
city: DeSoto
country: United States
facility: Epic Medical Research - Texas
state: Texas
city: El Paso
country: United States
facility: Great Lakes Research Institute El Paso Research
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: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Juno Research LLC
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates PA
state: Texas
city: Pharr
country: United States
facility: Great Lakes Research Institute - McAllen Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Sugar Land
country: United States
facility: Sugar Lakes Family Practice
state: Texas
city: Bountiful
country: United States
facility: Pantheon Clinical Research
state: Utah
city: Layton
country: United States
facility: Alliance for Multispecialty Research Layton Research Center
state: Utah
city: Saint George
country: United States
facility: Chrysalis Clinical Research, LLC
state: Utah
city: Arlington
country: United States
facility: Washington Center for Weight Management and Research, Inc
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads
state: Virginia
city: Winchester
country: United States
facility: Selma Medical Associates
state: Virginia
city: Milwaukee
country: United States
facility: Allegiance Research Specialists
state: Wisconsin
city: Botany
country: Australia
facility: Emeritus Research Sydney
state: New South Wales
city: Kotara
country: Australia
facility: Novatrials
state: New South Wales
city: Miranda
country: Australia
facility: Sutherland Shire Clinical Research
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Clinical Research
state: New South Wales
city: Meadowbrook
country: Australia
facility: Logan Hospital
state: Queensland
city: Norwood
country: Australia
facility: Fusion Clinical Research
state: South Australia
city: Oaklands Park
country: Australia
facility: Southern Adelaide Diabetes and Endocrine Services
state: South Australia
city: Altona North
country: Australia
facility: Altona Clinical Research
state: Victoria
city: Camberwell
country: Australia
facility: Emeritus Research Camberwell
state: Victoria
city: Heidelberg West
country: Australia
facility: Austin Health, Heidelberg Repatriation Hospital
state: Victoria
city: Surrey
country: Canada
facility: tlc Diabetes and Endocrinology
state: British Columbia
city: Hamilton
country: Canada
facility: Wharton Medical Clinic
state: Ontario
city: North York
country: Canada
facility: North York Diagnostic and Cardiac Centre
state: Ontario
city: Scarborough
country: Canada
facility: Heart Health Institute Research Incorporated
state: Ontario
city: Thunder Bay
country: Canada
facility: Curans Heart Center
state: Ontario
city: Toronto
country: Canada
facility: Centricity Research Toronto
state: Ontario
city: Chicoutimi
country: Canada
facility: Ecogene-21
state: Quebec
city: St Jean sur Richelieu
country: Canada
facility: CardioVasc HR Incorporated
state: Quebec
city: Terrebonne
country: Canada
facility: Centre de Medecine Metabolique de Lanaudiere
state: Quebec
city: Yokohama-shi
country: Japan
facility: Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
state: Kanagawa
city: Chiyoda-ku
country: Japan
facility: Doujin Memorial Foundation, Meiwa Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo Asbo Clinic
state: Tokyo
city: Hachioji-shi
country: Japan
facility: Medical Corp Seikoukai New Medical Research System Clinic
state: Tokyo
city: Minato-ku
country: Japan
facility: Medical Corporation AOT Shinagawa Strings Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Clinical Research Hospital Tokyo
state: Tokyo
city: Suginami-ku
country: Japan
facility: Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic
state: Tokyo
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc
city: Ponce
country: Puerto Rico
facility: Puerto Rico Medical Research Inc.
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: Vega Baja
country: Puerto Rico
facility: Wellness Clinical Research Vega Baja
city: Geneve 14
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Sankt Gallen
country: Switzerland
facility: Kantonsspital Sankt Gallen
city: Sankt Gallen
country: Switzerland
facility: Stoffwechselzentrum Sankt Gallen
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich
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: Ely
country: United Kingdom
facility: Staploe Medical Centre
city: Glasgow
country: United Kingdom
facility: FutureMeds Glasgow
city: Penzance
country: United Kingdom
facility: Atlantic Medical Group
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: