Bivamelagon Long-Term Extension Study
Research type
Research Study
Full title
A Long-term, Open-Label Extension Study of Bivamelagon in Participants with Hypothalami Obesity (HO)
IRAS ID
1012863
Contact name
Heather Winn
Contact email
Sponsor organisation
Rhythm Pharmaceuticals, Inc.
Research summary
Hypothalamic obesity (HO) is a condition caused by physical damage to a part of the brain called the hypothalamus. This results in a disruption of a specific pathway in the brain, called MC4R. The MC4R pathway helps to control appetite, energy levels, and body weight. The disrupted MC4R pathway leads to the “turning off” of an action in the brain that controls hunger and energy output (metabolism). This can contribute to increased food intake and obesity.
The most common cause of HO is a brain tumour or tumour therapies, including surgery and radiation.
Patients with HO often have difficulty losing weight through available interventions.
The purpose of this Open-Label Extension study is to characterise the long-term safety and tolerability of bivamelagon in participants who have transitioned from the LG-MCCL005 study with bivamelagon.
The study drug is a tablet which will be taken orally once a day with water, preferably in the morning before eating. Depending on the last dose participants received in the LG-MCCL005 study, they will take a 200 mg (1 tablet), 400 mg (2 tablets), or 600 mg (3 tablets) dose per day in this study.
Participation in the study will last for up to 2 years on bivamelagon treatment with up to 8 visits to the study site. This study has a follow-up period of approximately 4 weeks at the end of the treatment period.
A total of approximately 26 participants will be enrolled onto this study at study sites in the United States (US) and the United Kingdom (UK).
The Sponsor of this study is Rhythm Pharmaceuticals, Inc.REC name
Wales REC 3
REC reference
25/WA/0261
Date of REC Opinion
6 Oct 2025
REC opinion
Further Information Favourable Opinion