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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Rhythm Pharmaceuticals, Inc.
Study ID
NCT07156578
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Hypothalamic Obesity

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bivamelagon — DRUG
    daily dose of oral bivamelagon

Study Details

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.

Key Dates

Start date
Nov 10, 2025
Status verified
Feb 2026
Primary completion
Apr 15, 2028
Completion
Apr 15, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bivamelagon (open-label)

Primary Outcome Measure

Safety and tolerability of bivamelagon as assessed by the number and frequency of AEs [ Time Frame: Baseline to up to 2 years ]

Locations (6)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045-
University of Iowa Children's HospitalIowa CityIowa52242-
Tufts Medical CenterBostonMassachusetts02111-
Columbia UniversityNew YorkNew York10027-
The University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
St. Jude Children's Research HospitalMemphisTennessee38105-

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado· Aurora, COUniversity of Iowa Children's Hospital· Iowa City, IATufts Medical Center· Boston, MAColumbia University· New York, NYThe University of North Carolina at Chapel Hill· Chapel Hill, NCSt. Jude Children's Research Hospital· Memphis, TN

Related Studies