Hypothalamic Obesity Clinical Trial
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
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.
Status | Not yet recruiting |
Enrollment | 28 |
Est. completion date | January 31, 2026 |
Est. primary completion date | January 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Key Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rhythm Pharmaceuticals, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean percentage change in BMI | From Baseline to Week 14 | ||
Secondary | Frequency and severity of adverse events (AEs) | From Baseline to Week 52 | ||
Secondary | Mean change in BMI | Baseline to Weeks 6, 10, 14 | ||
Secondary | Proportion of patients who achieve =5% reduction in body weight | Baseline to Week 14 | ||
Secondary | Mean change in the weekly average of the daily most hunger score | Baseline to Week 14 | ||
Secondary | Mean change and mean percentage change from baseline in body weight | From Baseline to Week 52 | ||
Secondary | Mean change and mean percentage change from baseline in waist circumference. | From Baseline to Week 52 | ||
Secondary | 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 | From Baseline to Week 52 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02849743 -
Intranasal Oxytocin in Hypothalamic Obesity
|
Phase 2 | |
Recruiting |
NCT06217848 -
The Effect of GLP-1 Agonist in Patients With Hypothalamic Obesity: Prospective, Pilot Study
|
Early Phase 1 | |
Withdrawn |
NCT05147415 -
Study of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO)
|
Phase 2 | |
Completed |
NCT00892073 -
Hypothalamic Obesity Following Craniopharyngioma Surgery: A Pilot Trial of Combined Metformin and Diazoxide Therapy
|
Phase 2 | |
Not yet recruiting |
NCT06299891 -
Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity
|
Phase 2 | |
Recruiting |
NCT06239116 -
A Study of RM-718 in Healthy Subjects and in Patients With HO
|
Phase 1 | |
Completed |
NCT02664441 -
Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity
|
Phase 3 | |
Completed |
NCT04725240 -
Open-Label Study of Setmelanotide in Hypothalamic Obesity
|
Phase 2 | |
Completed |
NCT03673813 -
A Personalized Program of Physical Activity and Diet for Hypothalamic Obesity
|
||
Withdrawn |
NCT03708913 -
Neuromodulation for Hypothalamic Obesity
|
N/A | |
Completed |
NCT01061775 -
Effects of Exenatide on Hypothalamic Obesity
|
Phase 1/Phase 2 | |
Completed |
NCT02860923 -
Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy
|
Phase 3 | |
Completed |
NCT00171613 -
A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients
|
Phase 4 | |
Recruiting |
NCT01783717 -
Effects of Exenatide on Obesity and/or Diabetes Mellitus Due to Hypothalamic Damage
|
N/A | |
Enrolling by invitation |
NCT05774756 -
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
|
Phase 3 | |
Completed |
NCT05319301 -
Identification and Clinical Relevance of an Oxytocin Deficient State (Melatonin Study)
|
N/A |