340 Participants Needed

Maridebart Cafraglutide for Obesity

Recruiting at 3 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 a new treatment called maridebart cafraglutide, a potential drug for weight management, to observe its behavior in the body when administered as a single dose to individuals with overweight or obesity. Researchers compare two different administration methods to determine which is more effective. This study suits individuals with a body mass index (BMI) between 25 and 40 who do not have diabetes or certain other health conditions. 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.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any over-the-counter or prescription medications at least 30 days before the trial, unless the investigator approves otherwise. This includes herbal medicines, vitamins, and supplements.

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. In one study, researchers found no unexpected safety problems. Patients tolerated the treatment well, and the side effects were manageable. This suggests the drug is relatively safe for people at this stage. However, as this trial remains in an early phase, researchers continue to collect safety information. More research is needed to confirm these results.12345

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

Maridebart Cafraglutide is unique because it offers a fresh approach to treating obesity by potentially enhancing how the body manages weight. Unlike current treatments like lifestyle changes, medications such as orlistat, or GLP-1 receptor agonists like semaglutide, this drug works by using a new active ingredient that might stimulate weight loss in a different way. Researchers are particularly excited about its novel delivery method, which could improve how effectively the body absorbs the treatment, potentially leading to better results for individuals struggling with obesity.

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

Research has shown that maridebart cafraglutide may aid in weight loss. In earlier studies, individuals with obesity lost an average of up to 20% of their weight. For those with both obesity and type 2 diabetes, the weight loss averaged about 17%. This trial will test two different presentations of maridebart cafraglutide. The treatment imitates a hormone that reduces hunger and manages blood sugar levels. Early results suggest it could effectively help people with obesity lose a significant amount of weight.13678

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for individuals living with overweight or obesity. Specific details about who can join are not provided, but typically participants must meet certain health criteria and be within a specific age range.

Inclusion Criteria

Body mass index between ≥25.0 and <40.0 kg/m^2.
I am between 18 and 60 years old.
I am not pregnant or breastfeeding.

Exclusion Criteria

History of hypersensitivity, intolerance, or allergy to maridebart cafraglutide or related/similar compounds or their ingredients.
History or evidence, at screening or check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
History of or active diabetes (regardless of type, with the exception of a history of gestational diabetes) or hemoglobin A1C ≥6.5% (≥48 mmol/mol).
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of maridebart cafraglutide using one of two SC presentations

Single dose

Follow-up

Participants are monitored for safety and pharmacokinetics after receiving the single dose

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Maridebart Cafraglutide
Trial Overview The study is testing how the body processes a single dose of Maridebart Cafraglutide when given in two different subcutaneous (under the skin) forms to people with overweight or obesity.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Maridebart Cafraglutide SC Presentation 1Experimental Treatment1 Intervention
Group II: Maridebart Cafraglutide SC Presentation 2Active Control1 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

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.govpubmed.ncbi.nlm.nih.gov/40549887/
Once-Monthly Maridebart Cafraglutide for the Treatment of ...Conclusions: In this phase 2 trial, once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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