Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT06046443
PHASE2

A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity

Sponsor: Rhythm Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The goal of this study was to determine how well LB54640 (also known as bivamelagon) worked and how safe it was in participants with Hypothalamic Obesity (HO). The study evaluated the effect of bivamelagon on safety, weight reduction, hunger, and quality of life in participants 12 years of age and older with HO. Participants took an oral daily dose of either bivamelagon (low, middle, or high dose) or placebo through Week 14. Eligible participants who consented to continue in the study after Week 14 took an oral daily dose of bivamelagon through Week 52.

Official title: A Randomized, Placebo-controlled, Double-Blind Phase 2 Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity, With an Open-Label Extension

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2024-07-11

Completion Date

2026-02-09

Last Updated

2026-10-30

Healthy Volunteers

No

Interventions

DRUG

Bivamelagon

Oral daily administration

DRUG

Placebo

Placebo matched to LB54640

Locations (10)

Children's Hospital Colorado

Aurora, Colorado, United States

University of Iowa Children's Hospital

Iowa City, Iowa, United States

Tufts Medical Center

Boston, Massachusetts, United States

Columbia University

New York, New York, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, United Kingdom

University of Cambridge

Cambridge, United Kingdom

Great Ormond Street Hospital for Children

London, United Kingdom