300 Participants NeededMy employer runs this trial

Maridebart Cafraglutide for Obesity

Recruiting at 44 trial locations
AC
Overseen ByAmgen Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Amgen
Must be taking: GLP-1RA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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?

This trial tests a new treatment called maridebart cafraglutide, a potential drug for individuals with obesity or who are overweight. Researchers aim to determine if switching from GLP-1RA to maridebart cafraglutide is safe, effective, and well-tolerated. Two different dosing schedules are under evaluation to identify the most effective one. This trial may suit individuals who have lost at least 10% of their weight using GLP-1RA, maintain a stable weight, and do not have conditions like diabetes or thyroid cancer. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it requires a stable dose of GLP-1RA (a type of medication for weight loss) before switching to the trial drug.

Is there any evidence suggesting that maridebart cafraglutide is likely to be safe for humans?

Research has shown that maridebart cafraglutide was safe in earlier studies. In past research, people with obesity lost significant weight using this treatment, and no major safety issues emerged. Most participants tolerated the treatment well. Some experienced mild side effects, but these were usually easy to manage. The fact that maridebart cafraglutide is now in a late-stage study suggests that earlier trials found it reasonably safe for people.12345

Why are researchers excited about this trial's treatments?

Maridebart cafraglutide is unique because it targets obesity with a novel mechanism that differs from traditional options like appetite suppressants or metabolic boosters. This treatment works by enhancing the body's natural hormone pathways to regulate hunger and energy use, potentially offering more effective weight management. Researchers are excited about maridebart cafraglutide because it could provide sustained weight loss with fewer side effects, making it a promising alternative for those struggling with obesity.

What evidence suggests that maridebart cafraglutide could be an effective treatment for obesity?

Studies have shown that maridebart cafraglutide can significantly aid weight loss in people with obesity. In earlier research, participants lost nearly 20% of their body weight on average, a substantial difference compared to the 2.6% loss in those who took a placebo. These findings indicate that this treatment could be highly effective for weight loss. In this trial, participants will receive maridebart cafraglutide according to different dosing schedules in separate arms. The promising results suggest that maridebart cafraglutide could be a strong option for managing obesity.13467

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults who are overweight or have obesity (BMI of 25 or higher), have already lost at least 10% of their weight using a weekly GLP-1 medication, and whose weight and medication dose have been stable. Participants must tolerate their current medicine well and agree to use contraception if female.

Inclusion Criteria

I have lost at least 10% of my weight while on weekly GLP-1 RA medication.
* Stable body weight.
* Willingness to follow trial procedures for the duration of the trial.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive maridebart cafraglutide according to dosing schedule 1 or 2

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Maridebart Cafraglutide

Trial Overview

The study tests the effects, safety, and tolerability of switching from a current GLP-1RA medication to maridebart cafraglutide in people with obesity or overweight. All participants will switch medications as part of the research.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: MariTide Arm 2Experimental Treatment1 Intervention
Group II: MariTide Arm 1Experimental Treatment1 Intervention

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

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40549887/

Once-Monthly Maridebart Cafraglutide for the Treatment of ...

In this phase 2 trial, once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity with or without type 2 ...

RESULTS FROM AMGEN'S PHASE 2 OBESITY STUDY ...

In the Phase 2 study, MariTide demonstrated up to ~20% average weight loss in people living with obesity without Type 2 diabetes (T2D) compared ...

NCT06858839 | Evaluation of Maridebart Cafraglutide in ...

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.

Once-Monthly Maridebart Cafraglutide for the Treatment ...

In this phase 2 trial, once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity with or without type 2 ...

Once-Monthly Maridebart Cafraglutide Shows Up to 16% ...

Patients with obesity saw weight loss from 16.3% to nearly 20% when taking maridebart cafraglutide compared with just 2.6% with placebo; ...

RESULTS FROM AMGEN'S PHASE 2 OBESITY STUDY ...

MariTide demonstrated up to ~20% average weight loss in people living with obesity without Type 2 diabetes (T2D) compared with 2.6% in the ...

7.

maritimestudy.com

maritimestudy.com/

Clinical Trials for Weight management | MariTide (maridebart ...

The MARITIME Phase 3 clinical studies are exploring how safe and effective MariTide is in reducing body weight and addressing obesity related diseases.