Maridebart Cafraglutide for Obesity
(MARITIME-1 Trial)
Recruiting at 65 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Amgen
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
Research Team
M
MD
Principal Investigator
Amgen
Eligibility Criteria
This trial is for adults over 18 who are obese or overweight with a BMI of at least 30, or between 27 and 30 if they have related health issues like high blood pressure. Participants should have tried losing weight unsuccessfully before.Inclusion Criteria
I am 18 years old or older.
History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise
My BMI is over 27 and I have a weight-related health issue.
Exclusion Criteria
I have had chronic pancreatitis or an acute pancreatitis attack in the last 6 months.
I have lost or gained more than 5 kg in the last 3 months.
Lifetime history of suicide attempt
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Treatment Details
Interventions
- Maridebart Cafraglutide (GLP-1 Receptor Agonist)
Trial OverviewThe study aims to see if Maridebart Cafraglutide helps people lose more body weight compared to a placebo (a treatment with no active drug).
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Maridebart Cafraglutide Medium DoseExperimental Treatment1 Intervention
Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.
Group II: Maridebart Cafraglutide Low DoseExperimental Treatment1 Intervention
Participants will receive maridebart cafraglutide low dose SC for 72 weeks.
Group III: Maridebart Cafraglutide High DoseExperimental Treatment1 Intervention
Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive placebo SC for 72 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London