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Bivamelagon

Phase 2

Hypothalamic Obesity | Small molecule | Metabolic |Rhythm Pharmaceuticals, Inc.|Last Updated: Feb 10, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07156578A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)PHASE2 ENROLLING BY_INVITATION 25 — — Nov 10, 2025Apr 15, 2028Feb 10, 20269 United States, United Kingdom
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Study Endpoints
Primary Endpoints
Safety and tolerability of bivamelagon as assessed by the number and frequency of AEs
Baseline to up to 2 years
Secondary Endpoints
Mean change and mean percentage change from Baseline in BMI in participants ≥18 years of age.
Baseline to up to 2 years
Mean change in BMI z-score in participants >18 years of age.
Baseline to up to 2 years
Mean change in and mean percentage change in weight
Baseline to up to 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Bivamelagon (open-label)EXPERIMENTAL -
Interventions
NameTypeDescription
BivamelagonDRUGdaily dose of oral bivamelagon
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Key Inclusion Criteria: * 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. Ke...

Countries:United StatesUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07156578primaryCompletionDate: changed
LOWMay 24, 2026NCT07156578studyFirstPostDate: changed