Maridebart Cafraglutide for Fatty Liver Disease
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 determine its effectiveness in reducing liver fat and body weight in individuals who are overweight or have obesity and high liver fat. Participants will receive either the treatment or a placebo (a substance with no active drug), along with a diet and exercise plan, over the course of a year. The trial seeks individuals who have unsuccessfully tried to lose weight through diet and exercise, have a BMI between 27 and 40, and have high liver fat, as determined by a scan. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
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. However, if you have type 2 diabetes, you can continue with a stable treatment of metformin or SGLT-2 inhibitors.
Is there any evidence suggesting that maridebart cafraglutide is likely to be safe for humans?
Research has shown that maridebart cafraglutide can aid in weight loss, with results ranging from 16% to 20%. This significantly outperforms the placebo group, which lost only 2.6%. Studies find that maridebart cafraglutide is generally safe for most individuals. However, concerns exist for those with severe liver disease due to how their bodies process the drug. Overall, evidence suggests the treatment is safe for most, but individual experiences may vary. Always consult a healthcare provider for personalized advice.12345
Why do researchers think this study treatment might be promising?
Maridebart Cafraglutide is unique because it targets fatty liver disease with a new active ingredient, offering a fresh approach compared to standard treatments like lifestyle changes or medications aimed at controlling diabetes and cholesterol. Most existing treatments focus on managing symptoms indirectly, but Maridebart Cafraglutide is designed to be a direct intervention with its novel mechanism of action. Additionally, it is administered as a subcutaneous injection every four weeks, which could offer greater convenience than daily oral medications. Researchers are excited about its potential to provide a more targeted and efficient treatment option for patients with fatty liver disease.
What evidence suggests that maridebart cafraglutide might be an effective treatment for fatty liver disease?
Studies have shown that maridebart cafraglutide can lead to significant weight loss. People with obesity lost up to 16.2% of their body weight after 52 weeks, with some losing nearly 20%, compared to just 2.6% with a placebo. Early research suggests that this treatment might also reduce liver fat and improve liver health. In this trial, participants will receive either maridebart cafraglutide or a placebo to evaluate its potential benefits for people with fatty liver disease.12356
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 or older who are overweight or obese (BMI between 27 and 40), have high liver fat (at least 10%), and have tried but not succeeded in losing weight with diet and exercise. Their blood sugar must be under control, and they may be on certain diabetes medications.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive maridebart cafraglutide or placebo as a subcutaneous injection every 4 weeks for 52 weeks, alongside a reduced-calorie diet and increased physical activity
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 to a placebo, both given along with a reduced-calorie diet and more physical activity, to see if the drug helps lower liver fat and body weight better than placebo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive maridebart cafraglutide as a subcutaneous (SC) injection every 4 weeks (Q4W) for 52 weeks.
Participants will receive placebo as a SC injection Q4W for 52 weeks.
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
Evaluating Efficacy and Safety of Maridebart Cafraglutide ...
The main objective of this trial will be to determine whether maridebart cafraglutide is superior to placebo on reduction in liver fat content and body ...
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 ...
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; ...
Press Releases
MariTide demonstrated up to ~20% average weight loss at week 52 without a weight loss plateau, indicating the potential for further weight loss beyond 52 weeks.
Study Details | NCT06858878 | Efficacy and Safety of ...
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
Efficacy and safety of anti-obesity drugs in metabolic ... - PMC
However, their use in advanced liver disease raises concerns due to altered pharmacokinetics and limited safety data. ... References to non-alcoholic fatty liver ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.