NCT07156578Enrolling by invitationPhase 2
A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
A Long-Term, Open-Label Extension Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 25 Aug 2025
- Start date
- 10 Nov 2025
- Primary completion date
- 15 Apr 2028
- Lead sponsor
- Rhythm Pharmaceuticals, Inc.
- Diseases
- Obesity
- NCT number
- NCT07156578
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 25
- From 10 Nov 2025 to the primary completion date, 15 Apr 2028
- 9 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Willing to remain off of: CYP3A4 inhibitors, strong CYP3A4 inducers, and P-glycoprotein inhibitors or substrates for the duration of the study.
Other
- In the opinion of the Investigator, participant is not suitable to participate in the study.
- Other protocol defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- 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.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Birmingham Women's and Children's NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| University of Cambridge Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Great Ormond Street Hospital for Children Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Tufts Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| The University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| University of Iowa Children's Hospital Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.