AMG 133 for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and tolerance of a new treatment called maridebart cafraglutide (also known as AMG 133) for individuals with obesity. Researchers test different doses to observe the body's reaction to both single and multiple doses. Participants will receive either the actual treatment or a placebo, which contains no active medicine. Ideal candidates are those living with obesity, maintaining a stable weight, and otherwise healthy. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial requires that you stop taking most prescription and nonprescription drugs, herbal medicines, vitamins, and supplements before starting the study, unless approved by the study doctor. There is a specific period of 14 days or 5 half-lives (whichever is longer) for prescription and nonprescription drugs, and 30 days for herbal medicines, vitamins, and supplements before the first dose of the study drug.
Is there any evidence suggesting that maridebart cafraglutide is likely to be safe for humans?
Research has shown that maridebart cafraglutide, the treatment used in this trial, has a good safety record. One study found that participants tolerated the treatment well, with no major side effects. Additionally, the study found no significant safety differences between those who took the treatment and those who did not, suggesting that maridebart cafraglutide is generally safe. However, since this trial is in the early stages, researchers continue to collect safety information.12345
Why are researchers excited about this trial's treatment for obesity?
Unlike the standard treatments for obesity, which often include lifestyle changes and medications like appetite suppressants or fat absorption inhibitors, maridebart cafraglutide is a novel approach. This investigational drug is unique because it is designed to potentially target specific pathways related to appetite regulation and energy balance, offering a fresh angle on weight management. Researchers are excited about its potential to provide more effective and possibly quicker results with different dosing strategies. Additionally, its innovative mechanism could lead to fewer side effects compared to current medications, which can sometimes cause digestive issues or increased heart rate.
What evidence suggests that maridebart cafraglutide might be an effective treatment for obesity?
This trial will evaluate maridebart cafraglutide across various treatment arms. Studies have shown that maridebart cafraglutide can help people with obesity lose a significant amount of weight. In one study, participants lost an average of up to 20% of their body weight, indicating the treatment's potential effectiveness for weight loss. Research has also found that the treatment improved health markers in animal studies, suggesting promising potential benefits. These findings provide strong evidence for maridebart cafraglutide's effectiveness in treating obesity.13678
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single and multiple ascending doses of maridebart cafraglutide or placebo
Open-label extension
Participants in Part C receive open-label multiple ascending doses of maridebart cafraglutide
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AMG 133
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Placebo Group
Up to 2 open-label, multiple ascending dose cohorts (cohorts 12 to 13) treated with doses previously studied in Part A and Part B.
Up to 4 multiple ascending dose cohorts (cohorts 7 to 10).
Up to 7 single ascending dose cohorts (cohorts 1 to 6 and cohort 11).
Up to 7 single ascending dose cohorts (cohorts 1 to 6 and cohort 11).
Up to 4 multiple ascending dose cohorts (cohorts 7 to 10).
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 ...
2.
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 ...
NCT05669599 | Dose-ranging Study to Evaluate the ...
The study aims to compare and assess the dose response of 3 selected doses of maridebart cafraglutide compared with placebo, on inducing and maintaining weight ...
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 ...
Phase I results for AMG 133 | Nature Reviews Endocrinology
Treating male obese mice and cynomolgus monkeys with AMG 133 resulted in reduced body weight and improved metabolic parameters, including blood ...
6.
medchemexpress.com
medchemexpress.com/maridebart-cafraglutide.html?srsltid=AfmBOorSVut09kU83YalYp1go4AaxzHvIREzhi95dsHpSvUBtM5bLPIQMaridebart cafraglutide (Synonyms: AMG 133)
Maridebart cafraglutide. Inquiry Online. Your information is safe with us. ... SAFETY DATA SHEET (SDS). English - EN (251 KB) Français - FR (251 KB) Deutsch ...
A GIPR antagonist conjugated to GLP-1 analogues promotes ...
Clinical safety profile AMG 133 has an acceptable safety and tolerability profile. There were no notable differences between treatment groups for clinical ...
RESULTS FROM AMGEN'S PHASE 2 OBESITY STUDY ...
MariTide, the first monthly or less frequently dosed obesity treatment, demonstrated up to ~20% average weight loss without a weight loss plateau.
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