Maridebart Cafraglutide for Obesity

(MARITIME-2 Trial)

Not currently recruiting at 234 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether maridebart cafraglutide can help people lose weight more effectively than a placebo (a substance with no active medication). It tests different doses to determine which is most effective. Suitable participants are adults with a body mass index (BMI) of 27 or higher, who have not succeeded with diet and exercise, and have type 2 diabetes (a condition where the body cannot use insulin properly). As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for weight loss.

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.

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

Research has shown that maridebart cafraglutide has been tested in people with obesity and type 2 diabetes. In these studies, participants lost a significant amount of weight. For instance, some trials reported an average weight loss of up to 20% in those without type 2 diabetes.

The studies also examined how well participants tolerated the treatment. Although detailed safety information for each dose is not provided here, the treatment's progression to a late-stage trial suggests it has been deemed safe enough to reach this point.

Earlier trials likely found it generally well-tolerated with manageable side effects. If the FDA approves the treatment for another condition, it further supports its safety in humans. However, joining a trial requires discussing potential risks with the study team to determine if it's suitable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Unlike the standard treatments for obesity, which often include lifestyle changes and medications like orlistat, liraglutide, or phentermine, Maridebart Cafraglutide offers a unique approach. Researchers are excited about this treatment because it uses a new active ingredient, potentially providing a different mechanism of action that targets obesity more effectively. Additionally, Maridebart Cafraglutide is administered subcutaneously, which might improve patient compliance compared to oral medications. With high, medium, and low dose options being explored, this treatment could offer tailored solutions to meet individual patient needs.

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

Research has shown that maridebart cafraglutide can aid weight loss in people with obesity. In earlier studies, participants taking this treatment lost up to 20% of their body weight. Those with type 2 diabetes experienced nearly 17% weight loss. Another study reported an average weight loss of 12.3% for individuals with both obesity and diabetes. These findings suggest that maridebart cafraglutide could be highly effective for weight loss. Participants in this trial will receive a high, medium, or low dose of maridebart cafraglutide, or a placebo, to further evaluate its effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

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?

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.

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 ...

2.

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 ...

3.

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 ...

4.

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 ...

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.

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 ...

7.

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 ...