Maridebart Cafraglutide for Obesity
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 individuals with obesity or who are overweight. Researchers aim to determine if switching from GLP-1RA to maridebart cafraglutide is safe, effective, and well-tolerated. Two different dosing schedules are under evaluation to identify the most effective one. This trial may suit individuals who have lost at least 10% of their weight using GLP-1RA, maintain a stable weight, and do not have conditions like diabetes or thyroid cancer. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it requires a stable dose of GLP-1RA (a type of medication for weight loss) before switching to the trial drug.
Is there any evidence suggesting that maridebart cafraglutide is likely to be safe for humans?
Research has shown that maridebart cafraglutide was safe in earlier studies. In past research, people with obesity lost significant weight using this treatment, and no major safety issues emerged. Most participants tolerated the treatment well. Some experienced mild side effects, but these were usually easy to manage. The fact that maridebart cafraglutide is now in a late-stage study suggests that earlier trials found it reasonably safe for people.12345
Why are researchers excited about this trial's treatments?
Maridebart cafraglutide is unique because it targets obesity with a novel mechanism that differs from traditional options like appetite suppressants or metabolic boosters. This treatment works by enhancing the body's natural hormone pathways to regulate hunger and energy use, potentially offering more effective weight management. Researchers are excited about maridebart cafraglutide because it could provide sustained weight loss with fewer side effects, making it a promising alternative for those struggling with obesity.
What evidence suggests that maridebart cafraglutide could be an effective treatment for obesity?
Studies have shown that maridebart cafraglutide can significantly aid weight loss in people with obesity. In earlier research, participants lost nearly 20% of their body weight on average, a substantial difference compared to the 2.6% loss in those who took a placebo. These findings indicate that this treatment could be highly effective for weight loss. In this trial, participants will receive maridebart cafraglutide according to different dosing schedules in separate arms. The promising results suggest that maridebart cafraglutide could be a strong option for managing obesity.13467
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for adults who are overweight or have obesity (BMI of 25 or higher), have already lost at least 10% of their weight using a weekly GLP-1 medication, and whose weight and medication dose have been stable. Participants must tolerate their current medicine well and agree to use contraception if female.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive maridebart cafraglutide according to dosing schedule 1 or 2
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Maridebart Cafraglutide
Trial Overview
The study tests the effects, safety, and tolerability of switching from a current GLP-1RA medication to maridebart cafraglutide in people with obesity or overweight. All participants will switch medications as part of the research.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive maridebart cafraglutide dosing schedule 2 during the treatment period.
Participants will receive maridebart cafraglutide dosing schedule 1 during the treatment period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
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
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 ...
2.
investors.amgen.com
investors.amgen.com/news-releases/news-release-details/results-amgens-phase-2-obesity-study-monthly-maritide-presentedRESULTS 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 ...
NCT06858839 | Evaluation of Maridebart Cafraglutide in ...
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
Once-Monthly Maridebart Cafraglutide for the Treatment ...
In this phase 2 trial, once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity with or without type 2 ...
Once-Monthly Maridebart Cafraglutide Shows Up to 16% ...
Patients with obesity saw weight loss from 16.3% to nearly 20% when taking maridebart cafraglutide compared with just 2.6% with placebo; ...
RESULTS FROM AMGEN'S PHASE 2 OBESITY STUDY ...
MariTide demonstrated up to ~20% average weight loss in people living with obesity without Type 2 diabetes (T2D) compared with 2.6% in the ...
Clinical Trials for Weight management | MariTide (maridebart ...
The MARITIME Phase 3 clinical studies are exploring how safe and effective MariTide is in reducing body weight and addressing obesity related diseases.
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