Maridebart Cafraglutide for Obesity

(MARITIME-1 Trial)

Not currently recruiting at 311 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Disqualifiers: Diabetes, Endocrine disorders, Pancreatitis, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if maridebart cafraglutide aids weight loss more effectively than a placebo (a fake treatment). Researchers will test different doses of the drug to identify the most effective one for reducing body weight. Suitable participants have a BMI over 30 or a BMI between 27 and 30 with conditions such as high blood pressure or sleep apnea and have unsuccessfully tried to lose weight through diet and exercise. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking weight-loss 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 coordinators or your doctor.

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

Research has shown that maridebart cafraglutide was safe in earlier studies. One study found no unexpected safety issues, indicating it was generally well-tolerated by participants. Another study reported that the treatment's side effects were manageable.

These findings provide some confidence about the drug's safety. However, as this is a Phase 3 trial, maridebart cafraglutide is still being tested for safety and effectiveness in a larger group. More data is being collected to confirm these earlier results. For specific concerns or questions, discussing them with a doctor is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for obesity?

Researchers are excited about Maridebart Cafraglutide for obesity because it offers a novel approach compared to current treatments like lifestyle changes, medications such as orlistat, or GLP-1 receptor agonists like semaglutide. Unlike these options, Maridebart Cafraglutide is a new drug that might work more effectively by impacting specific pathways in the body responsible for weight regulation. It is administered through a subcutaneous injection, which can help ensure consistent dosing. The study investigates different doses, including high, medium, and low, to find the most effective and safest option, potentially offering a tailored approach to treating obesity.

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

Research has shown that maridebart cafraglutide helps people with obesity lose weight. In one study, participants without type 2 diabetes lost an average of up to 20% of their body weight. Another study found that individuals with obesity lost up to 19.9% of their weight, while those with both obesity and type 2 diabetes lost 17%. These findings suggest that maridebart cafraglutide can significantly aid weight loss in people with obesity, regardless of diabetes status. ^{1 3 6 7 8}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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

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

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 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Maridebart Cafraglutide

Trial Overview

The study aims to see if Maridebart Cafraglutide helps people lose more body weight compared to a placebo (a treatment with no active drug).

How Is the Trial Designed?

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05669599

NCT05669599 | Dose-ranging Study to Evaluate the ...

The study aims to compare and assess the dose response of 3 selected doses of maridebart cafraglutide compared with placebo, on inducing and maintaining weight ...

2.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2504214

Once-Monthly Maridebart Cafraglutide for the Treatment ...

Participants with obesity and type 2 diabetes had a mean weight reduction of up to 12.3% (treatment policy estimand), accompanied by a mean ...

3.

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 ...

4.

investors.amgen.com

investors.amgen.com/news-releases/news-release-details/results-amgens-phase-2-obesity-study-monthly-maritide-presented

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 ...

5.

ajmc.com

ajmc.com/view/weight-loss-drug-maridebart-cafraglutide-shows-efficacy-in-phase-2-trial

Weight-Loss Drug Maridebart Cafraglutide Shows Efficacy ...

Maridebart cafraglutide showed up to 19.9% weight loss in obesity and 17% in obesity-diabetes patients in a phase 2 trial. The drug's 21-day ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06987695

Efficacy and Safety of Maridebart Cafraglutide in Adult ...

Self-reported change in body weight > 5 kg within 90 days before screening. Previous or planned (during the study) surgical, endoscopic, or device-based ...

7.

amgen.com

amgen.com/newsroom/press-releases/2025/06/results-from-amgens-phase-2-obesity-study-of-monthly-maritide-presented-at-the-american-diabetes-association-85th-scientific-sessions

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 ...

8.

amgentrials.com

amgentrials.com/study/?id=20190218

AMGEN - Dose-ranging Study to Evaluate the Efficacy, ...

The study aims to compare and assess the dose response of 3 selected doses of maridebart cafraglutide compared with placebo, on inducing and maintaining weight ...