3200 Participants NeededMy employer runs this trial

Maridebart Cafraglutide for Obesity

Recruiting at 86 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?

This trial focuses on testing maridebart cafraglutide, a potential treatment for individuals with obesity or who are overweight. Researchers aim to assess the effectiveness, safety, and tolerability of this treatment over the long term. Participants from a previous trial continue with different doses or a placebo to compare results. Those who completed the previous parent trial and are managing obesity without planned surgery might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that maridebart cafraglutide is generally safe for treating obesity. In earlier studies, participants did not encounter any unexpected safety problems. Common side effects affected the stomach and intestines, such as nausea or diarrhea. These side effects were milder when starting with a low dose and gradually increasing it. No new safety issues emerged, so the treatment appears safe based on previous research.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about maridebart cafraglutide for obesity because it offers a unique approach compared to current treatments like appetite suppressants or metabolic boosters. Unlike most obesity treatments that focus on suppressing appetite or increasing metabolism, maridebart cafraglutide is a novel compound that potentially targets different biological pathways to promote weight loss. The flexibility in dosing schedules, such as once every 4, 8, or even 12 weeks, could enhance patient compliance and convenience, setting it apart from daily medications. Additionally, the varied dosing options might allow for personalized treatment plans, which is a promising step forward in obesity management.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that maridebart cafraglutide can help people with obesity lose a significant amount of weight. Specifically, studies found that participants without type 2 diabetes lost up to 20% of their weight on average, while those with type 2 diabetes lost up to 17%. In contrast, participants who took a placebo lost only about 2.6% of their weight. This trial will administer maridebart cafraglutide in various dosages and frequencies, including monthly and less frequent doses, to evaluate its effectiveness. Overall, maridebart cafraglutide appears effective in helping people with obesity shed pounds.23467

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for people who finished a previous obesity study (parent trial), completed the week 72 visit, did not stop their treatment early, and agree to use contraception as required. Participants must join within 7 days of finishing the parent trial.

Inclusion Criteria

I have signed the consent form and agree to follow the study rules.
I have completed the parent trial 2010181.
I have finished the week 72 visit in the parent trial.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants who received placebo in the parent trial will undergo a dose-escalation phase gradually increasing doses before receiving high dose of maridebart cafraglutide

4-8 weeks

Treatment

Participants receive maridebart cafraglutide or placebo subcutaneously at varying doses and intervals

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Maridebart cafraglutide

Trial Overview

The study compares maridebart cafraglutide with a placebo to see how safe and effective it is for long-term use in people with obesity or overweight. It continues from an earlier related trial.

How Is the Trial Designed?

10

Treatment groups

Experimental Treatment

Placebo Group

Group I: Maridebart Cafraglutide Medium Dose Q8WExperimental Treatment1 Intervention
Group II: Maridebart Cafraglutide Medium Dose Q4WExperimental Treatment1 Intervention
Group III: Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial)Experimental Treatment1 Intervention
Group IV: Maridebart Cafraglutide Low Dose Q4WExperimental Treatment1 Intervention
Group V: Maridebart Cafraglutide High Dose Q8WExperimental Treatment1 Intervention
Group VI: Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)Experimental Treatment1 Intervention
Group VII: Maridebart Cafraglutide High Dose Q4WExperimental Treatment1 Intervention
Group VIII: Maridebart Cafraglutide High Dose Q12WExperimental Treatment1 Intervention
Group IX: Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)Placebo Group1 Intervention
Group X: Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)Placebo Group1 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

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 ...

2.

pubmed.ncbi.nlm.nih.gov

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

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

once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity with or without type 2 diabetes.

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 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; ...

5.

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.

Study Details | NCT07441252 | A Trial to Evaluate Efficacy ...

A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight ClinicalTrials.gov

Efficacy and Safety of Maridebart Cafraglutide in Adult ...

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