999 Participants Needed

Maridebart Cafraglutide for Obesity

(MARITIME-2 Trial)

Recruiting at 160 trial locations
AC
Overseen ByAmgen Call Center
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the drug Maridebart Cafraglutide differ from other obesity treatments?

Maridebart Cafraglutide is a novel treatment for obesity, potentially offering a new mechanism of action or formulation compared to existing drugs like orlistat and sibutramine, which have limitations in effectiveness and side effects. While specific details about Maridebart Cafraglutide are not provided, it represents an emerging option in the evolving field of obesity pharmacotherapy.12345

What data supports the effectiveness of the drug Maridebart Cafraglutide for obesity?

The research highlights that while current anti-obesity drugs like orlistat and sibutramine show limited effectiveness, new drugs targeting neuroendocrine mechanisms regulating body weight are being developed. Additionally, the use of gut hormone analogues, similar to liraglutide, has shown promise in reducing body weight and improving cardiovascular risk factors, suggesting potential effectiveness for Maridebart Cafraglutide if it shares similar mechanisms.16789

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

Adults with Type 2 Diabetes Mellitus (T2DM) who are overweight or have obesity can join this trial. They should be at least 18 years old, have a BMI of 27 kg/m^2 or higher, and have tried losing weight unsuccessfully through diet and exercise.

Inclusion Criteria

My BMI is 27 or higher.
I have tried and failed to lose weight through diet and exercise.
I have been diagnosed with type 2 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive maridebart cafraglutide or placebo subcutaneously for 72 weeks

72 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Maridebart Cafraglutide
Trial Overview The trial is testing the effectiveness of Maridebart cafraglutide compared to a placebo in reducing body weight percentage among adults with T2DM who are also overweight or obese.
How Is the Trial Designed?
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 profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Published Research Related to This Trial

Sibutramine, a serotonin/noradrenaline reuptake inhibitor, has been shown to reduce body weight by an average of 4.45 kg compared to placebo, while also improving triglycerides and HDL cholesterol, but it may cause increased heart rate and has contraindications for patients with uncontrolled hypertension or cardiovascular issues.
Orlistat, a pancreatic lipase inhibitor, results in an average weight loss of 2.89 kg and significantly decreases waist circumference and blood pressure, but primarily causes gastrointestinal side effects and should be avoided in patients with chronic malabsorption.
[Pharmacological therapy of obesity].Pagotto, U., Vanuzzo, D., Vicennati, V., et al.[2018]

Citations

Emerging drugs for obesity therapy. [2019]
2.Czech Republicpubmed.ncbi.nlm.nih.gov
[Drug treatment of obesity--current situation and perspectives]. [2011]
Effects of a novel combination of orlistat and acarbose on tolerability, appetite, and glucose metabolism in persons with obesity. [2022]
Liraglutide: a review of its use in the management of obesity. [2022]
Current pharmacological approaches to the treatment of obesity. [2018]
[Pharmacological therapy of obesity]. [2018]
Safety of a Novel Weight Loss Combination Product Containing Orlistat and Acarbose. [2022]
Orlistat. No hurry.... [2018]
Current Perspectives on Long-term Obesity Pharmacotherapy. [2016]
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