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Enrolling by invitationPHASE2INTERVENTIONAL

A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)

This research study is called "A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)." It's for people who have Hypothalamic Obesity, a condition that can make it hard to control your weight. The study is looking at a new medicine called Bivamelagon. This isn't a new trial from scratch; it's a chance for people who have already tried Bivamelagon in a previous study (called LG-MCCL005) to continue taking it for a longer time. Researchers want to see how well Bivamelagon works and if it continues to be safe over a longer period, up to two years. It's open to both males and females, aged 12 and over.

At a glance

Status
Enrolling by invitation
Phase
PHASE2
Sponsor
Rhythm Pharmaceuticals, Inc.
Enrolment target
25
Start
10 Nov 2025
Estimated completion
15 Apr 2028
Hypothalamic Obesity

What is this study about?

This study is focused on a health problem called Hypothalamic Obesity, often shortened to HO. This condition can affect how your body controls hunger and weight, sometimes leading to significant weight gain. Researchers are interested in a new medicine called Bivamelagon that they hope might help improve this condition.

This isn't the first time Bivamelagon has been studied. This particular study is designed for people who have already taken part in an earlier study (called LG-MCCL005) where they received Bivamelagon. The main goal here is to see how Bivamelagon works over a longer time – up to two years – and to make sure it remains safe and effective for people with HO.

By continuing to study Bivamelagon in this long-term way, doctors hope to gather more important information. This will help them understand if the medicine can provide lasting benefits and if there are any long-term effects. This research is a vital step in learning more about how to manage Hypothalamic Obesity.

Key takeaways

  • This study is for long-term treatment with Bivamelagon for Hypothalamic Obesity.
  • It's only for people who were in a previous Bivamelagon study (LG-MCCL005).
  • The study aims to check the safety and effectiveness of Bivamelagon over two years.
  • Both males and females aged 12 and over can participate.
  • Participants must agree to specific birth control methods if applicable.
  • You can stop participating at any time.

Who may be eligible?

To join this particular study, you must have already taken part in a previous study called LG-MCCL005 where you received the medicine Bivamelagon. Importantly, the doctors in that study must have agreed that the medicine was safe for you and that you tolerated it well.

If you are able to become pregnant, you will need to agree to use effective birth control throughout the study and for 90 days after it finishes. This is a common requirement in many medical studies to ensure safety.

You should not join this study if you are taking certain other medications that might interfere with Bivamelagon. These include some medicines that affect how your body processes other drugs. Your doctor will be able to check if any of your current medicines would be a problem. Also, if your doctor feels for any reason that this study is not the right fit for you, you wouldn't be able to join. Other specific rules not listed here might also apply.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Did you take part in the previous study called LG-MCCL005 where you received Bivamelagon?
  2. Did your doctor say Bivamelagon was safe and well-tolerated by you in that previous study?
  3. If you can get pregnant, are you willing to use effective birth control during and after the study?
  4. Are you able to avoid certain other medications (like some CYP3A4 inhibitors/inducers or P-glycoprotein inhibitors/substrates) during the study?
  5. Has your doctor confirmed that this study is suitable for you?
Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to take the medicine Bivamelagon, which you started in a previous study. You will have regular visits with the study team, who will check your health, ask how you're feeling, and do tests to see how the medicine is working and if it's safe for you. These might include blood tests, physical exams, and other assessments. The study itself is designed to last for up to two years, meaning you could be taking the medicine and having check-ups for that period. You will also need to follow specific instructions about contraception if you are able to become pregnant. All these details will be fully explained to you before you decide if you wish to participate.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that you would continue to receive a medicine that might help manage your Hypothalamic Obesity for a longer period. However, there might be side effects from the medicine, and some of the tests involved could be uncomfortable or carry small risks. It's important to remember that you can stop being part of the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Children's Hospital Colorado
    Verified postcode
    Aurora, United States
  • University of Iowa Children's Hospital
    Verified postcode
    Iowa City, United States
  • Tufts Medical Center
    Verified postcode
    Boston, United States
  • Columbia University
    Verified postcode
    New York, United States
  • The University of North Carolina at Chapel Hill
    Verified postcode
    Chapel Hill, United States
  • St. Jude Children's Research Hospital
    Verified postcode
    Memphis, United States
  • Birmingham Women's and Children's NHS Foundation Trust
    Verified postcode
    Birmingham, United Kingdom
  • University of Cambridge
    Verified postcode
    Cambridge, United Kingdom
  • Great Ormond Street Hospital for Children
    Verified postcode
    London, United Kingdom

Common questions

What is Hypothalamic Obesity (HO)?

Hypothalamic Obesity is a condition where damage to part of the brain called the hypothalamus can affect appetite and how the body stores fat, making it difficult to control weight.

What is Bivamelagon?

Bivamelagon is a new medicine being studied to help people with Hypothalamic Obesity. This study is looking at how it works over a longer period.

How long will this study last?

This study is designed to be a long-term follow-up and could last for up to two years for each participant.

Do I have to pay to join this study?

No, you will not have to pay to take part in this research study. All study-related care and medicine will be provided.

What if I change my mind about taking part?

You are free to leave the study at any point, for any reason, without it affecting your medical care or relationship with your doctor.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Long-Term Study of Bivamelagon in Participants With Hypoth…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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