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 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.12345Why 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.12346
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive maridebart cafraglutide or placebo in a crossover design to assess QT/QTc 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 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?
3
Treatment groups
Experimental Treatment
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.
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.
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.
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 ...
Participants with obesity and type 2 diabetes had a mean weight reduction of up to 12.3% (treatment policy estimand), accompanied by a mean ...
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 ...
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 ...
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 ...
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 ...
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