Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06046443
Other study ID # LG-MCCL005
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 17, 2024
Est. completion date January 31, 2026

Study information

Verified date April 2024
Source Rhythm Pharmaceuticals, Inc.
Contact Rhythm Clinical Trials
Phone 857-264-4280
Email clinicaltrials@rhythmtx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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, 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LB54640
Oral daily administration
Placebo
Placebo matched to LB54640

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rhythm Pharmaceuticals, Inc.

Outcome

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
See also
  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