Maridebart Cafraglutide for Obesity

Recruiting at 1 trial location

Overseen By Amgen Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Must not be taking: QT prolonging drugs, GLP-1

Disqualifiers: Diabetes, Pancreatitis, Cancer, Heart disease, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 171 days

82 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called maridebart cafraglutide to assess its effects on heart rhythm in individuals who are overweight or have obesity. Participants will receive either the treatment or a placebo (a non-active substance) for comparison. The trial seeks individuals who have maintained a stable weight and lifestyle for the past three months. It excludes those with diabetes, recent pancreatitis, or major health changes in the past three months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop taking my current medications to join the trial?

Yes, you may need to stop taking certain medications. The trial requires that you do not use prescription drugs (other than hormone replacement or contraception) within 14 days of dosing, and you must avoid drugs that affect absorption, metabolism, or elimination within 30 days of dosing.

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

Research has shown that maridebart cafraglutide is generally safe for people. In a previous study, participants did not encounter any unexpected safety problems. The side effects were manageable, and most tolerated the treatment well.

Another study found that maridebart cafraglutide aided weight loss without causing major side effects. No serious health issues were reported, suggesting the treatment is relatively safe.

Overall, evidence suggests that maridebart cafraglutide is safe for people, but staying updated on new research findings is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Maridebart Cafraglutide is unique because it introduces a new approach to treating obesity by potentially targeting metabolic pathways differently than current options like orlistat or liraglutide. This investigational treatment may offer a novel mechanism of action that could enhance weight loss effectiveness and improve metabolic health. Researchers are excited about Maridebart Cafraglutide because it could provide an alternative for individuals who do not respond well to existing therapies, offering hope for better, more personalized obesity management in the future.

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

Research has shown promising results for maridebart cafraglutide in treating obesity. People with obesity and type 2 diabetes lost an average of up to 12.3% of their body weight. Those without type 2 diabetes lost even more, with an average weight loss of about 20%. Participants in this trial may receive this medication, which is taken once a month and significantly reduces body weight. These findings suggest that maridebart cafraglutide could be a strong option for managing obesity. ^{1 2 3 4 6}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

Adults aged 18-60 with a BMI of 25.0 to 35.0, not pregnant or breastfeeding, and using effective birth control can join this trial. They should understand the trial, have signed consent, stable weight and diet for the past 3 months, and normal blood mineral levels. Controlled high blood pressure or cholesterol is okay if treatment is stable.

Inclusion Criteria

Provide signed and dated informed consent before any trial procedures

Be able to understand the trial requirements, sign the consent form, and follow trial restrictions

Body mass index (BMI) between 25.0 and 35.0 kg/m^2 (inclusive)

Exclusion Criteria

Current or recent suicidal thoughts (per Columbia Suicide Severity Rating Scale [C-SSRS])

Lifetime history of suicide attempt or behavior

Abnormal vital signs: average blood pressure > 140/90 mmHg or < 90/50 mmHg, or heart rate > 110 or < 40 bpm

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 in a crossover design to assess QT/QTc intervals

Up to 171 days

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 Maridebart Cafraglutide's effects on heart electrical activity in overweight individuals by comparing it against a placebo. It measures changes from baseline in QT interval (a heart rhythm measure) corrected for heart rate after subcutaneous injections.

How Is the Trial Designed?

Group I: Group 2B Experimental Treatment 3 Interventions

In treatment period 1, participants will receive placebo for moxifloxacin. In treatment period 2, participants will receive placebo for maridebart cafraglutide. In treatment period 3, participants will receive moxifloxacin.

Group II: Group 2A Experimental Treatment 3 Interventions

In treatment period 1, participants will receive moxifloxacin. In treatment period 2, participants will receive placebo for maridebart cafraglutide. In treatment period 3, participants will receive placebo for moxifloxacin.

Group III: Group 1 Experimental Treatment 2 Interventions

In treatment period 1, participants will receive placebo for moxifloxacin. In treatment period 2, participants will receive maridebart cafraglutide. In treatment period 3, participants will receive placebo for moxifloxacin.

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

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. 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06987695

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 and proportion of ...

4. 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 ...

5. medicine.yale.edu medicine.yale.edu/news-article/once-monthly-obesity-medication-shows-promise-for-those-with-and-without-type-2-diabetes/

Once-Monthly Obesity Medication Shows Promise for Those ... Overall, the study showed that the obesity-only cohort lost up to an average of 20% of their body weight, while the obesity-diabetes cohort lost ...

6. 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 ...