Maridebart Cafraglutide for Obesity

Not currently recruiting at 2 trial locations
AC
Overseen ByAmgen Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how maridebart cafraglutide interacts with a common oral contraceptive in postmenopausal women who are overweight or obese. Researchers aim to determine if this treatment can safely and effectively manage weight without affecting the contraceptive. Postmenopausal women with stable weight and no recent dietary changes might be suitable candidates for this trial. 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 it.

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

The trial requires participants to stop using most prescription or over-the-counter medications, certain hormone therapies, and specific supplements before joining. If you're taking any of these, you may need to stop them to participate.

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

Research has shown that maridebart cafraglutide was generally well-tolerated in earlier studies. In trials where participants received the treatment monthly, significant reductions in body weight indicated the drug's effectiveness. Importantly, these studies did not reveal major safety concerns for those using the drug to manage obesity. However, some reports have raised potential effects on bone health, but the company behind the drug has dismissed these concerns as unfounded. Since the current trial is in its early stages, it mainly focuses on how the drug interacts with other medications, so safety information is still being collected. Participants should discuss any concerns with the trial team to make an informed decision.12345

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

Maridebart Cafraglutide is unique because it combines a novel active ingredient with a subcutaneous delivery method to target obesity. Unlike traditional oral medications or lifestyle interventions for obesity, which often focus on appetite suppression or calorie restriction, Maridebart Cafraglutide works by acting directly on hormone pathways that regulate metabolism and energy balance. Researchers are excited about this treatment because it has the potential to offer more effective weight management with fewer side effects, addressing a critical need for new and innovative obesity solutions.

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

Research has shown that maridebart cafraglutide yields promising results for weight loss in people with obesity. In earlier studies, participants lost between 16% and 20% of their body weight after using the drug. This contrasts sharply with the 2.6% weight loss observed in those taking a placebo (a treatment with no active drug). Importantly, this weight loss persisted for over a year without slowing, indicating that the benefits did not diminish over time. These findings suggest maridebart cafraglutide could be an effective option for managing weight in individuals with obesity.12346

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for postmenopausal women aged 45-65 with a BMI between 25 and 35, whose weight has been stable and who have not recently changed their diet. Participants must not have diabetes, certain cancers, serious heart or liver problems, blood clotting issues, or recent substance use.

Inclusion Criteria

Body weight must be stable, with less than 5 kg self-reported change in the 3 months before screening.
Participants must not have changed their diet or started a nutritional lifestyle modification program within 3 months before screening.
Other inclusion criteria may apply.
See 2 more

Exclusion Criteria

Other exclusion criteria may apply.
I have a history of certain thyroid cancers or uncontrolled thyroid disease.
I do not have allergies or intolerances to maridebart cafraglutide, ethinyl estradiol, or orgestimate.
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive COC orally and maridebart cafraglutide subcutaneously to assess pharmacokinetics

6-8 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 how the drug maridebart cafraglutide affects the way combined oral contraceptives are absorbed and processed in the body of overweight or obese postmenopausal women. Participants receive both treatments to compare effects.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: COC + Maridebart CafraglutideExperimental Treatment2 Interventions

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/

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