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Enrolling by invitationPhase 2

Long-Term Study of Bivamelagon in Hypothalamic Obesity

Tests bivamelagon, a long-term extension, in people with hypothalamic obesity who joined a prior study.

Key facts

Who runs it
Rhythm Pharmaceuticals, Inc.
Where
Aurora, Boston, Chapel Hill, Iowa City, Memphis, and New York, United StatesSee the 6 sitesAlso in 1 other country, 3 sites
Trial code
Registry title
A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
Status
Enrolling by invitation
Phase
Phase 2
People taking part
25 people, planned
Started
10 Nov 2025
Expected to end
15 Apr 2028
Type of study
Interventional
Treatments tested
  • Bivamelagon
Record updated
10 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with hypothalamic obesity who finished the earlier study LG-MCCL005 and tolerated it well. The study lasts up to 2 years.

Age
12 years and older
Sex
All sexes can join.
Disease stage
Hypothalamic obesity.
Earlier treatment
Must have completed the earlier study LG-MCCL005 with adequate safety and tolerability.

Main reasons for not taking part

  • Not willing to stay off CYP3A4 inhibitors, strong CYP3A4 inducers, and P-glycoprotein inhibitors or substrates during the study
  • Not willing to use a highly effective form of contraception during the study and for 90 days after
  • The investigator judges that the person should not take part

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • Completed LG-MCCL005 and participant demonstrated adequate safety and tolerability in that study as determined by the Investigator
  • Agree to use a highly effective form of contraception and follow contraception requirements throughout the study and for 90 days after

Who cannot take part

  • Willing to remain off of: CYP3A4 inhibitors, strong CYP3A4 inducers, and P-glycoprotein inhibitors or substrates for the duration of the study
  • In the opinion of the Investigator, participant is not suitable to participate in the study; Other protocol defined Inclusion/Exclusion criteria may apply

Where in United States

Also in 1 other country, 3 sites

  • Children's Hospital ColoradoAurora, United StatesEnrolling by invitation
  • Tufts Medical CenterBoston, United StatesEnrolling by invitation
  • The University of North Carolina at Chapel HillChapel Hill, United StatesEnrolling by invitation
  • University of Iowa Children's HospitalIowa City, United StatesEnrolling by invitation
  • St. Jude Children's Research HospitalMemphis, United StatesEnrolling by invitation
  • Columbia UniversityNew York, United StatesEnrolling by invitation

About the trial

What the trial wants to find out

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.

The group in the trial

  • Bivamelagon (open-label)Treatment being tested

    Treatment: Bivamelagon

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Long-Term, Open-Label Extension Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
Plain-language title
Long-Term Study of Bivamelagon in Hypothalamic ObesityGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
10 February 2026