Maridebart Cafraglutide for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on testing maridebart cafraglutide, a potential treatment for individuals with obesity or who are overweight. Researchers aim to assess the effectiveness, safety, and tolerability of this treatment over the long term. Participants from a previous trial continue with different doses or a placebo to compare results. Those who completed the previous parent trial and are managing obesity without planned surgery might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that maridebart cafraglutide is generally safe for treating obesity. In earlier studies, participants did not encounter any unexpected safety problems. Common side effects affected the stomach and intestines, such as nausea or diarrhea. These side effects were milder when starting with a low dose and gradually increasing it. No new safety issues emerged, so the treatment appears safe based on previous research.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about maridebart cafraglutide for obesity because it offers a unique approach compared to current treatments like appetite suppressants or metabolic boosters. Unlike most obesity treatments that focus on suppressing appetite or increasing metabolism, maridebart cafraglutide is a novel compound that potentially targets different biological pathways to promote weight loss. The flexibility in dosing schedules, such as once every 4, 8, or even 12 weeks, could enhance patient compliance and convenience, setting it apart from daily medications. Additionally, the varied dosing options might allow for personalized treatment plans, which is a promising step forward in obesity management.
What evidence suggests that this trial's treatments could be effective for obesity?
Research has shown that maridebart cafraglutide can help people with obesity lose a significant amount of weight. Specifically, studies found that participants without type 2 diabetes lost up to 20% of their weight on average, while those with type 2 diabetes lost up to 17%. In contrast, participants who took a placebo lost only about 2.6% of their weight. This trial will administer maridebart cafraglutide in various dosages and frequencies, including monthly and less frequent doses, to evaluate its effectiveness. Overall, maridebart cafraglutide appears effective in helping people with obesity shed pounds.23467
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for people who finished a previous obesity study (parent trial), completed the week 72 visit, did not stop their treatment early, and agree to use contraception as required. Participants must join within 7 days of finishing the parent trial.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants who received placebo in the parent trial will undergo a dose-escalation phase gradually increasing doses before receiving high dose of maridebart cafraglutide
Treatment
Participants receive maridebart cafraglutide or placebo subcutaneously at varying doses and intervals
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 compares maridebart cafraglutide with a placebo to see how safe and effective it is for long-term use in people with obesity or overweight. It continues from an earlier related trial.
How Is the Trial Designed?
10
Treatment groups
Experimental Treatment
Placebo Group
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC once in 8weeks (Q8W).
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC Q4W.
Participants who permanently de-escalated to very low dose of maridebart cafraglutide in the parent trial will receive low dose of maridebart cafraglutide SC Q4W.
Participants who received low dose of maridebart cafraglutide in the parent trial (20210181 \[NCT06858839\]) will continue to receive low dose of maridebart cafraglutide subcutaneously (SC) once in 4 weeks(Q4W).
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q8W.
Participants who received placebo in the parent trial will receive high dose of maridebart cafraglutide SC Q4W. Prior to initiating the assigned high dose, participants will undergo a dose-escalation phase gradually increasing doses.
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q4W.
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC once in 12 weeks (Q12W).
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.
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
1.
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 ...
Once-Monthly Maridebart Cafraglutide for the Treatment of ...
once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity with or without type 2 diabetes.
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 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; ...
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.
Study Details | NCT07441252 | A Trial to Evaluate Efficacy ...
A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight ClinicalTrials.gov
7.
ctv.veeva.com
ctv.veeva.com/study/efficacy-and-safety-of-maridebart-cafraglutide-in-adult-participants-with-type-2-diabetes-mellitus-wEfficacy 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.
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