A Phase 2 interventional study of LB54640 and Placebo in Hypothalamic Obesity, sponsored by Rhythm Pharmaceuticals, Inc.. Completed at 10 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Rhythm Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
The goal of this study is to determine how well LB54640 works and how safe it is in patients with Hypothalamic Obesity (HO). The study will evaluate the effect of LB54640 on safety, weight reduction, hunger, and quality of life in patients 12 years of age and older with HO. Patients will take an oral daily dose of either LB54640 (low, middle, or high dose) or placebo through Week 14. Eligible patients who consent to continue in the study after Week 14 will take an oral daily dose of LB54640 through Week 56.
Rhythm Pharmaceuticals, Inc. is the lead sponsor of 28 studies on the registry; 3 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 12 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
Participants will be randomized to receive LB54640 low dose, middle dose, or high dose, or placebo by oral administration in a 1:1:1:1 ratio.
Drug: LB54640
Participants will be randomized to receive LB54640 low dose, middle dose, or high dose, or placebo by oral administration in a 1:1:1:1 ratio.
Drug: LB54640
Participants will be randomized to receive LB54640 low dose, middle dose, or high dose, or placebo by oral administration in a 1:1:1:1 ratio.
Drug: LB54640
Participants will be randomized to receive LB54640 low dose, middle dose, or high dose, or placebo by oral administration in a 1:1:1:1 ratio.
Drug: Placebo
Eligible participants who provide consent to continue into the open-label portion of the study will receive open-label LB54640.
Drug: LB54640
Oral daily administration
Placebo matched to LB54640
Mean percentage change in BMI
Time frame: From Baseline to Week 14
Frequency and severity of adverse events (AEs)
Time frame: From Baseline to Week 52
Mean change in BMI
Time frame: Baseline to Weeks 6, 10, 14
Proportion of patients who achieve ≥5% reduction in body weight
Time frame: Baseline to Week 14
Mean change in the weekly average of the daily most hunger score
Time frame: Baseline to Week 14
Mean change and mean percentage change from baseline in body weight
Time frame: From Baseline to Week 52
Mean change and mean percentage change from baseline in waist circumference.
Time frame: From Baseline to Week 52
Mean change and mean percentage change from baseline in body composition assessed by dual energy x-ray absorptiometry
Fat mass and lean mass will be measured through dual energy x-ray absorptiometry
Time frame: From Baseline to Week 52
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Rhythm Pharmaceuticals, Inc.