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Bivamelagon

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

Bivamelagon · 1 trial · 1 indication

Phase 2 1
NCT07156578A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)Hypothalamic Obesity
ENROLLING BY_INVITATION25 Analytics
PHASE2ENROLLING BY_INVITATION
A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
Hypothalamic ObesityUnlock trial analytics

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 to 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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Frequently asked questions about Bivamelagon

What is Bivamelagon used for?

Bivamelagon is an investigational small molecule being developed for the treatment of hypothalamic obesity, a form of obesity that results from damage to the hypothalamus. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Bivamelagon?

Bivamelagon is being developed by Rhythm Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol RYTM. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with hypothalamic obesity.

What phase is Bivamelagon in?

Bivamelagon is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its potential as a treatment for hypothalamic obesity.

What clinical trials is Bivamelagon in?

Bivamelagon is being studied in a Phase 2 clinical trial with the identifier NCT07156578. This long-term study is enrolling participants with hypothalamic obesity by invitation and aims to include 25 participants in the United States and United Kingdom.

Is Bivamelagon the same as any other drug?

No alternative names for Bivamelagon have been disclosed. It is identified solely by its generic name, Bivamelagon, in clinical trial registries and by its developer, Rhythm Pharmaceuticals.