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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06858839




Registration number
NCT06858839
Ethics application status
Date submitted
28/02/2025
Date registered
5/03/2025

Titles & IDs
Public title
Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
Scientific 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
Secondary ID [1] 0 0
2024-515524-36
Secondary ID [2] 0 0
20210181
Universal Trial Number (UTN)
Trial acronym
MARITIME-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Maridebart Cafraglutide
Treatment: Drugs - Placebo

Experimental: Maridebart Cafraglutide High Dose - Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.

Experimental: Maridebart Cafraglutide Medium Dose - Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.

Experimental: Maridebart Cafraglutide Low Dose - Participants will receive maridebart cafraglutide low dose SC for 72 weeks.

Placebo comparator: Placebo - Participants will receive placebo SC for 72 weeks.


Treatment: Drugs: Maridebart Cafraglutide
Maridebart cafraglutide will be administered SC.

Treatment: Drugs: Placebo
Placebo will be administered SC.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Body Weight at Week 72
Timepoint [1] 0 0
Baseline and Week 72
Secondary outcome [1] 0 0
Change From Baseline in Waist Circumference at Week 72
Timepoint [1] 0 0
Baseline and Week 72
Secondary outcome [2] 0 0
Participant achieving = 5% reduction in body weight from baseline at week 72
Timepoint [2] 0 0
Week 72
Secondary outcome [3] 0 0
Participant achieving = 10% reduction in body weight from baseline at week 72
Timepoint [3] 0 0
Week 72
Secondary outcome [4] 0 0
Participant achieving = 15% reduction in body weight from baseline at week 72
Timepoint [4] 0 0
Week 72
Secondary outcome [5] 0 0
Participant achieving = 20% reduction in body weight from baseline at week 72
Timepoint [5] 0 0
Week 72
Secondary outcome [6] 0 0
Change From Baseline in Systolic Blood Pressure (SBP) at Week 72
Timepoint [6] 0 0
Baseline and Week 72
Secondary outcome [7] 0 0
Percent Change From Baseline in Fasting Triglycerides at Week 72
Timepoint [7] 0 0
Baseline and Week 72
Secondary outcome [8] 0 0
Change From Baseline in Fasting Glucose at Week 72
Timepoint [8] 0 0
Baseline and Week 72
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Baseline and Week 72
Secondary outcome [10] 0 0
Change From Baseline in Body Weight at Week 72
Timepoint [10] 0 0
Baseline and Week 72
Secondary outcome [11] 0 0
Change From Baseline in Body Mass Index (BMI) at Week 72
Timepoint [11] 0 0
Baseline and Week 72
Secondary outcome [12] 0 0
Change From Baseline in Hemoglobin A1c at Week 72
Timepoint [12] 0 0
Baseline and Week 72
Secondary outcome [13] 0 0
Percent Change From Baseline in Fasting Insulin at Week 72
Timepoint [13] 0 0
Baseline and Week 72
Secondary outcome [14] 0 0
Change From Baseline in Glycemic Status at Week 72
Timepoint [14] 0 0
Baseline and Week 72
Secondary outcome [15] 0 0
Percent Change From Baseline in Fasting Lipid Parameters at Week 72
Timepoint [15] 0 0
Baseline and Week 72
Secondary outcome [16] 0 0
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 72
Timepoint [16] 0 0
Baseline and Week 72
Secondary outcome [17] 0 0
Percent Change From Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72
Timepoint [17] 0 0
Baseline and Week 72
Secondary outcome [18] 0 0
Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72
Timepoint [18] 0 0
Baseline and Week 72
Secondary outcome [19] 0 0
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [19] 0 0
Up to approximately 88 weeks
Secondary outcome [20] 0 0
Plasma Concentration of Maridebart Cafraglutide at Week 72
Timepoint [20] 0 0
Week 72

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/04/2027
Actual
Sample size
Target
3501
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Emeritus Research Sydney - Botany
Recruitment hospital [2] 0 0
Novatrials - Kotara
Recruitment hospital [3] 0 0
Sutherland Shire Clinical Research - Miranda
Recruitment hospital [4] 0 0
Wollongong Clinical Research - Wollongong
Recruitment hospital [5] 0 0
Logan Hospital - Meadowbrook
Recruitment hospital [6] 0 0
Fusion Clinical Research - Norwood
Recruitment hospital [7] 0 0
Altona Clinical Research - Altona North
Recruitment hospital [8] 0 0
Emeritus Research Camberwell - Camberwell
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2289 - Kotara
Recruitment postcode(s) [3] 0 0
2228 - Miranda
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [6] 0 0
5067 - Norwood
Recruitment postcode(s) [7] 0 0
3025 - Altona North
Recruitment postcode(s) [8] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Mississippi
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
Rhode Island
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Wisconsin
Country [29] 0 0
Japan
State/province [29] 0 0
Kanagawa
Country [30] 0 0
Japan
State/province [30] 0 0
Tokyo
Country [31] 0 0
Puerto Rico
State/province [31] 0 0
Ponce
Country [32] 0 0
Puerto Rico
State/province [32] 0 0
San Juan
Country [33] 0 0
Puerto Rico
State/province [33] 0 0
Vega Baja

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06858839