A Phase 2 interventional study of Bivamelagon in Hypothalamic Obesity, sponsored by Rhythm Pharmaceuticals, Inc.. Enrolling by invitation at 9 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Rhythm Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
This is a long-term, open-label extension study of bivamelagon in participants with Hypothalamic Obesity (HO) who have transitioned from the index study, LG-MCCL005. The study will last up to 2 years.
23 studies on the registry are indexed under Sexual Infantilism; 5 are open to participants now.
This study's planned enrollment of 25 is below the median of 30 across 20 interventional studies indexed under Sexual Infantilism.
Browse Sexual Infantilism studies →Rhythm Pharmaceuticals, Inc. is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 14 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Bivamelagon
daily dose of oral bivamelagon
Safety and tolerability of bivamelagon as assessed by the number and frequency of AEs
Time frame: Baseline to up to 2 years
Mean change and mean percentage change from Baseline in BMI in participants ≥18 years of age.
Time frame: Baseline to up to 2 years
Mean change in BMI z-score in participants >18 years of age.
Time frame: Baseline to up to 2 years
Mean change in and mean percentage change in weight
Time frame: Baseline to up to 2 years
Mean change in percentage of the 95th percentile of BMI in participants <18 years of age.
Time frame: Baseline to up to 2 years
Percentage of patients who achieve ≥5%,≥10%, ≥15%, and ≥20% reduction in BMI from baseline
Time frame: Baseline to up to 2 years
Mean change from Baseline in Physical function (and total score) for the Impact of Weight on Quality of Life-Lite (IWQoL) in participants ≥18 years of age
Time frame: Baseline to up to 2 years
Change from Baseline in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides
Time frame: Baseline to up 2 years
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: Bivamelagon
Rhythm Pharmaceuticals, Inc. →