Status:
ACTIVE_NOT_RECRUITING
A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity
Lead Sponsor:
Rhythm Pharmaceuticals, Inc.
Conditions:
Hypothalamic Obesity
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
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, ...
Eligibility Criteria
Inclusion
- Key
- Documented evidence of acquired hypothalamic obesity (HO)
- Age 12 years and older
- Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients \<18 years of age
- Male and female participants agree to follow study contraception requirements and use a highly effective form of contraception throughout the study and for 90 days after the study
- Key
Exclusion
- Weight loss \>2% in the previous 3 months for patients ≥18 years of age or \>2% reduction in BMI for patients \<18 years of age
- History of major surgical procedure within 30 days
- HbA1c \>10.9%
- Fasting glucose level \>270 mg/dL
- Previous use of MC4R agonists
- Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET).
- Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior
- History or close family history of skin cancer or melanoma
- Current clinically significant pulmonary, cardiac, or oncologic disease considered severe enough to interfere with the study and/or confound the results
- Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
July 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06046443
Start Date
July 11 2024
End Date
January 31 2026
Last Update
July 22 2025
Active Locations (10)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
University of Iowa Children's Hospital
Iowa City, Iowa, United States, 52242
3
Tufts Medical Center
Boston, Massachusetts, United States, 02111
4
Columbia University
New York, New York, United States, 10027