Maridebart Cafraglutide for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of a new treatment, maridebart cafraglutide, for individuals with obesity and type 2 diabetes. Researchers aim to determine its safety and efficacy over an extended period. Participants will receive varying doses of the treatment or a placebo for comparison. Ideal candidates include those who completed a previous related study and have been managing obesity and type 2 diabetes. As a Phase 3 trial, this study serves as the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that maridebart cafraglutide has undergone thorough safety testing. In earlier studies, it did not present any unexpected safety issues. However, some patients experienced common side effects like stomach problems. These side effects were milder when the treatment began with lower doses and increased gradually.
Importantly, recent research has not identified any new safety concerns, suggesting that maridebart cafraglutide is generally well-tolerated. Participants in those earlier trials also experienced significant weight loss, which is promising for individuals with obesity and type 2 diabetes.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Maridebart Cafraglutide for obesity because it offers a new approach to weight management by acting as a GLP-1 receptor agonist, which is different from many existing treatments that primarily focus on appetite suppression or calorie absorption. This compound is administered via a subcutaneous injection with varying dosages and frequencies, providing flexibility in treatment plans. Additionally, its potential for long-lasting effects due to less frequent dosing (every 4 to 8 weeks) could improve patient adherence compared to daily medications.
What evidence suggests that this trial's treatments could be effective for obesity and type 2 diabetes?
Research has shown that maridebart cafraglutide aids weight loss in people with obesity. One study revealed that participants taking the highest dose lost about 21.6% of their weight over a year. Another study found that monthly treatment led to a 15% weight loss. This trial will evaluate various dosing schedules of maridebart cafraglutide, including low, medium, and high doses administered every 4 or 8 weeks. The treatment affects the body's appetite and metabolism. Overall, maridebart cafraglutide has demonstrated strong and consistent weight loss results across different dosing schedules.678910
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for people with obesity and type 2 diabetes who completed a previous related study, did not stop the study drug early, and can use contraception as required. They must join within a week after finishing the earlier trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants continue to receive maridebart cafraglutide or placebo subcutaneously every 4 or 8 weeks, depending on their assigned group
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Maridebart Cafraglutide
Trial Overview
The study compares maridebart cafraglutide to a placebo to see how safe and effective it is when used long-term in people with obesity and type 2 diabetes. Participants are randomly assigned to either group.
How Is the Trial Designed?
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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 8 weeks (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 (20210184 \[NCT06858878\]) 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 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.
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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
Maridebart cafraglutide in Obesity and Overweight - ICH GCP
The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants ...
JPM26: Amgen touts MariTide's weight loss, T2D potential ...
MariTide demonstrated strong efficacy on a monthly dosing schedule, while also exhibiting its potential when administered quarterly.
What Does MariTide Do to Your Body?
Participants receiving the highest dose of 840 mg experienced an average weight loss of 8.2% by Day 92 Extended dosing results:Those in the
4.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/AMGN/pressreleases/36951957/amgen-advances-early-stage-obesity-candidate-with-new-injection-trial/Amgen Advances Early-Stage Obesity Candidate With ...
Study Overview: Amgen is running a Phase 1 trial to see how its obesity drug candidate, maridebart cafraglutide (AMG 133), behaves in the body ...
5.
stocktitan.net
stocktitan.net/news/AMGN/amgen-s-phase-2-maritide-data-to-be-presented-at-the-american-ja1x5x8nabic.htmlMonthly Obesity Drug MariTide Phase 2 Data Shows ...
MariTide demonstrated robust weight loss without plateau over 52 weeks in Phase 2 trials · MariTide offers unique monthly or less frequent dosing ...
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
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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 ...
Gastrointestinal adverse events were common with maridebart cafraglutide, No unexpected safety signals emerged.
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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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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