Bivamelagon for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called bivamelagon for individuals with Hypothalamic Obesity (HO), a condition that can lead to significant weight gain due to disruptions in the brain's regulation of hunger and energy. The trial aims to evaluate the long-term effectiveness and safety of bivamelagon for patients who completed a previous study with the same treatment. Participants who finished the earlier study and tolerated the treatment well may join this trial. The trial will last up to two years, concentrating on those who can adhere to specific medication restrictions. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
You will need to stop taking certain medications, specifically CYP3A4 inhibitors, strong CYP3A4 inducers, and P-glycoprotein inhibitors or substrates, for the duration of the study.
Is there any evidence suggesting that bivamelagon is likely to be safe for humans?
In earlier studies, bivamelagon showed promising safety results. Research indicates that bivamelagon is safe and effectively helps control appetite and weight. Participants generally tolerated the treatment well, with no unexpected safety issues. This drug has been tested in various settings, including a study comparing it to a placebo, a fake treatment.
The positive results from these studies support further testing of the drug. While side effects can occur, these findings suggest that bivamelagon is generally safe, making it a potential option for managing hypothalamic obesity.12345Why do researchers think this study treatment might be promising?
Bivamelagon is unique because it targets obesity through a novel mechanism of action. Unlike standard treatments like appetite suppressants or metabolic boosters, Bivamelagon works by specifically modulating pathways involved in energy balance and fat storage. Researchers are excited about this treatment as it offers a potentially more targeted approach, which could result in fewer side effects and more sustainable weight loss compared to existing options.
What evidence suggests that bivamelagon might be an effective treatment for hypothalamic obesity?
Research has shown that bivamelagon can help lower body mass index (BMI) in people with acquired hypothalamic obesity. One study found that participants taking a high dose of 600mg saw their BMI drop by 9.3%, while those on a medium dose of 400mg experienced a 7.7% decrease. In this trial, participants will receive bivamelagon in an open-label format. These findings suggest that bivamelagon could effectively manage weight for individuals with this specific type of obesity.12346
Who Is on the Research Team?
David Meeker, MD
Principal Investigator
Rhythm Pharmaceuticals, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals with Hypothalamic Obesity who completed the LG-MCCL005 study without major safety concerns. Participants must agree to effective contraception during the study and for 90 days after.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-label extension
Participants continue receiving bivamelagon in an open-label format
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bivamelagon
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rhythm Pharmaceuticals, Inc.
Lead Sponsor