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 observe its behavior in the body when administered as a single dose. The focus is on individuals living with overweight or obesity. Researchers compare two different methods of delivering this treatment under the skin. This trial may suit someone with a stable weight who struggles with weight management and has not recently used specific medications for diabetes or weight loss. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that maridebart cafraglutide appears safe for humans. In earlier studies, participants generally tolerated the treatment well, losing weight without unexpected safety issues. When tested for weight loss, it demonstrated promising results with a good safety record.
Although this trial is in its early phase, meaning the treatment is still under safety evaluation, previous studies have not reported major concerns. This suggests maridebart cafraglutide could be a safe option for people with obesity.12345Why do researchers think this study treatment might be promising for obesity?
Maridebart Cafraglutide is unique because it introduces a novel approach to tackling obesity using a specific active ingredient. Unlike traditional weight management treatments that often rely on lifestyle changes or medications like phentermine and liraglutide, Maridebart Cafraglutide targets obesity with potentially more effective outcomes. Researchers are particularly excited about its innovative mechanism of action and the use of subcutaneous delivery methods, which could offer improved patient compliance and quicker, more sustained weight loss results.
What evidence suggests that maridebart cafraglutide might be an effective treatment for obesity?
Research shows that maridebart cafraglutide can help people with obesity lose a significant amount of weight. One study revealed that participants lost an average of up to 20% of their body weight. Another study found weight loss ranging from 16.3% to nearly 20%, compared to just 2.6% with a placebo. In this trial, participants will receive maridebart cafraglutide using one of two different SC presentations to assess its effectiveness as a weight loss option for people with obesity.12346
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for adults aged 18-60 with a BMI between 25.0 and <40.0 kg/m^2, who have maintained a stable weight in the past three months. Women must not be pregnant or breastfeeding to participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of maridebart cafraglutide using one of two subcutaneous presentations
Follow-up
Participants are monitored for safety and pharmacokinetics after receiving the treatment
What Are the Treatments Tested in This Trial?
Interventions
- Maridebart Cafraglutide
Trial Overview
The trial is testing Maridebart Cafraglutide, a medication for obesity, by giving it as a single dose in two different subcutaneous (under the skin) forms to see how well it's absorbed into the body.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive a single dose of maridebart cafraglutide administered using SC presentation 1.
Participants will receive a single dose of maridebart cafraglutide administered using SC presentation 2.
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 ...
In this phase 2 trial, once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity with or without type 2 ...
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 ...
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; ...
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 ...
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 ...
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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