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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06046443
• Other study ID #: LG-MCCL005
• Status: Not yet recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Hypothalamic Obesity
• Obesity

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