A Phase 2, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity
Study Details
Study Description
Brief Summary
The goal of this trial is to determine the effect of LB54640 on weight reduction, hunger, and quality of life in patients 12 years of age and older with Hypothalamic Obesity (HO). To determine how well LB54640 works and how safe it is, patients with HO will take a daily dosing of either LB54640 or placebo and complete trial assessments for up to 56 weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LB54640 Low dose 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. |
Drug: LB54640
Oral daily administration
|
| Experimental: LB54640 Middle dose 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. |
Drug: LB54640
Oral daily administration
|
| Experimental: LB54640 High dose 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. |
Drug: LB54640
Oral daily administration
|
| Placebo Comparator: Placebo 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. |
Drug: Placebo
Placebo matched to LB54640
|
Outcome Measures
Primary Outcome Measures
- Change of BMI [From baseline to Week 14]
This will be measured in terms of changes in BMI. Body Mass Index (kg/m2) will be calculated from height and weight according to the following formula: Weight(kg)/[height (m)]2 (weight in kilograms divided by height in meters squared)
Secondary Outcome Measures
- Frequency and severity of adverse events (AE) [From first dose up to Week 52]
This will be measured frequency and severity of AEs
- Frequency and severity of adverse events of special interest (AESI) [From first dose up to Week 52]
This will be measured frequency and severity of AESIs. Adverse events of special interest are events of scientific and medical interest specific to the further understanding of the safety profile of the study intervention and require close monitoring and rapid communication by the investigators to the Sponsor.
- Mean change and mean percentage change from baseline in body weight [From first dose up to Week 52]
Body weight must be measured to the nearest 0.1 kg or 0.1 pounds. The same digital scale should be used throughout the study and the scale should be calibrated on a regular basis. Weight should be measured when participants are in the fasting state and without shoes; participants should have an empty bladder and must wear light clothing for weight assessment.
- Mean change and mean percentage change from baseline in waist circumference. Waist circumference was measured when participants were in fasting condition and at approximately the same time at each visit. [From first dose up to Week 52]
Waist circumference (cm) will be measured with a tape measure in a standing position. The waist circumference should be measured twice.
- Mean change and mean percentage change from baseline in Hunger Questionnaire Scores [From first dose up to Week 52]
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).
- Mean change and mean percentage change from baseline in body composition assessed by dual energy x-ray absorptiometry [From first dose up to Week 52]
Fat mass and lean mass will be measured through dual energy x-ray absorptiometry
Eligibility Criteria
Criteria
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 12 to <18 years of age
-
Agree to use a highly effective form of contraception throughout the study and for 90 days after the study
Exclusion Criteria:
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Weight loss >2% in the previous 2 months for patients
-
Use of any medication that is approved to treat obesity within 3 months of first dose of study drug.
-
History of major surgical procedure within 30 days
-
HbA1c >10.9%
-
Fasting glucose level >270 mg/dL
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Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior
-
History or close family history of skin cancer or melanoma
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- LG Chem
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LG-MCCL005