Maridebart Cafraglutide for Obesity

(MARITIME-2 Trial)

Recruiting at 70 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Disqualifiers: Type 1 diabetes, Pancreatitis, Severe psychiatric disorder, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 72 weeks

999 Participants Needed

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Maridebart Cafraglutide Medium Dose Experimental Treatment 1 Intervention

Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.

Group II: Maridebart Cafraglutide Low Dose Experimental Treatment 1 Intervention

Participants will receive maridebart cafraglutide low dose SC for 72 weeks.

Group III: Maridebart Cafraglutide High Dose Experimental Treatment 1 Intervention

Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive placebo SC for 72 weeks.

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

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacological therapy of obesity]. Pagotto, U., Vanuzzo, D., Vicennati, V., et al.[2018]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Emerging drugs for obesity therapy. [2019]

2. Czech Republic pubmed.ncbi.nlm.nih.gov

[Drug treatment of obesity--current situation and perspectives]. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of a novel combination of orlistat and acarbose on tolerability, appetite, and glucose metabolism in persons with obesity. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Liraglutide: a review of its use in the management of obesity. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Current pharmacological approaches to the treatment of obesity. [2018]

6. Italy pubmed.ncbi.nlm.nih.gov

[Pharmacological therapy of obesity]. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of a Novel Weight Loss Combination Product Containing Orlistat and Acarbose. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Orlistat. No hurry.... [2018]

9. Canada pubmed.ncbi.nlm.nih.gov

Current Perspectives on Long-term Obesity Pharmacotherapy. [2016]