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LB54640 for Obesity

Phase 2
Recruiting
Research Sponsored by LG Chem
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented evidence of acquired hypothalamic obesity (HO)
Age 12 years and older
Must not have
Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 52
Awards & highlights

Summary

This trial aims to assess the effectiveness and safety of medication LB54640 in patients with Hypothalamic Obesity. The study will look at how LB54640 affects safety, weight loss, appetite,

Who is the study for?
This trial is for individuals aged 12 and older with Hypothalamic Obesity, marked by weight gain after hypothalamic injury. Adults must have a BMI of ≥30 kg/m2, while those under 18 should be at or above the 95th percentile for their age and sex. Participants must agree to use effective contraception during the study and for three months after.
What is being tested?
The study tests LB54640's effectiveness in reducing weight, hunger, and improving quality of life in patients with Hypothalamic Obesity compared to a placebo. It involves taking an oral dose daily up to Week 14, with an option to continue until Week 56.
What are the potential side effects?
While specific side effects are not listed here, they may include typical drug reactions such as digestive issues, allergic responses, changes in appetite or mood swings. Safety will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with hypothalamic obesity.
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I am 12 years old or older.
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I have gained weight due to a brain injury and my BMI is over 30 if I'm an adult, or over the 95th percentile for my age and sex if I'm under 18.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with Prader-Willi syndrome or ROHHADNET.
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I have lost more than 2% of my weight in the last 3 months.
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I have used MC4R agonist medications before.
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I do not have severe psychiatric disorders or suicidal thoughts.
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I or my close family have a history of skin cancer or melanoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Mean change and mean percentage change from baseline in body composition assessed by dual energy x-ray absorptiometry

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Open-label LB54640Experimental Treatment1 Intervention
Eligible participants who provide consent to continue into the open-label portion of the study will receive open-label LB54640.
Group II: LB54640 Middle doseExperimental Treatment1 Intervention
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.
Group III: LB54640 Low doseExperimental Treatment1 Intervention
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.
Group IV: LB54640 High doseExperimental Treatment1 Intervention
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.
Group V: PlaceboPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

LG ChemLead Sponsor
63 Previous Clinical Trials
33,413 Total Patients Enrolled
Rhythm Pharmaceuticals, Inc.Lead Sponsor
27 Previous Clinical Trials
10,303 Total Patients Enrolled
3 Trials studying Hypothalamic Obesity
228 Patients Enrolled for Hypothalamic Obesity
David Meeker, MDStudy ChairRhythm Pharmaceuticals, Inc.
14 Previous Clinical Trials
1,565 Total Patients Enrolled
2 Trials studying Hypothalamic Obesity
138 Patients Enrolled for Hypothalamic Obesity
~19 spots leftby Jan 2026
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