LEPR Deficiency Obesity Clinical Trial
Official title:
A Phase 2, Single-arm, Open-label Study to Assess Efficacy and Safety of LB54640 in Patients With Obesity Due to POMC, PCSK1, or LEPR Deficiency.
Verified date | October 2023 |
Source | LG Chem |
Contact | LG CHEM |
Phone | +82-2-3777-1114 |
pathway[@]lgchem.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study was to assess the efficacy of LB54640 in participants with rare genetic disorders of obesity
Status | Not yet recruiting |
Enrollment | 4 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: - Participants aged =12 years at the time of enrollment and diagnosed with genetic obesity due to POMC, PCSK1, or LEPR deficiency mutations. - Obesity is defined as BMI =30 kg/m2 for participants =18 years of age or BMI =95th percentile for age and gender for participants <18 years of age. Exclusion Criteria: - Participants with recent (within 2 months, prior to Screening and up to enrollment) intensive diet/exercise regimen that resulted in >2% weight loss, use of medication to treat obesity (within 3 months of first dose of LB54640 with certain exceptions), or weight loss surgery within 6 months prior to Screening or prior surgery which resulted in >10% weight loss with no evidence of weight regain are excluded - History of major surgical procedure - Weight loss surgery within the previous 6 months - Any history of a suicide attempt, or any suicidal behavior - HbA1c >10.9% - Fasting glucose level >270 mg/dL |
Country | Name | City | State |
---|---|---|---|
France | Pitié Salpêtrière hospital and Sorbonne Université | Paris | |
United Kingdom | Cambridge university | Cambridge |
Lead Sponsor | Collaborator |
---|---|
LG Chem |
France, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of BMI | From baseline to Week 16 | ||
Secondary | Frequency and severity of adverse events (AE) | From first dose up to Week 52 | ||
Secondary | Frequency and severity of adverse events of special interest (AESI) | From first dose up to Week 52 | ||
Secondary | Mean change and mean percentage change from baseline in body weight | From baseline up to Week 52 | ||
Secondary | Mean change and mean percentage change from baseline in waist circumference. | From baseline up to Week 52 | ||
Secondary | Mean change and mean percentage change from baseline in Hunger Questionnaire Scores | The question will asked using the Hunger Questionnaire. The questionnaire consists of a new 5-item, patient-reported scale assessing major eating-related factors (worst and average hunger, appetite, craving, and satiety). | From baseline up 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 up to Week 52 |
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