Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06046443 | A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity | PHASE2 | COMPLETED | 28 | — | — | Jul 11, 2024 | Feb 9, 2026 | Feb 12, 2026 | 10 | United States, United Kingdom |
| Arm | Type | Description |
|---|---|---|
| LB54640 Low dose | EXPERIMENTAL | 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. |
| LB54640 Middle dose | EXPERIMENTAL | 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. |
| LB54640 High dose | EXPERIMENTAL | 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. |
| Placebo | PLACEBO_COMPARATOR | 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. |
| Open-label LB54640 | EXPERIMENTAL | Eligible participants who provide consent to continue into the open-label portion of the study will receive open-label LB54640. |
| Name | Type | Description |
|---|---|---|
| LB54640 | DRUG | Oral daily administration |
| Placebo | DRUG | Placebo matched to LB54640 |
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 f...