Approval Probability
TA Base Rate
Adjusted LOA
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LB54640 · 1 trial · 1 indication
| 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...
LB54640 is an investigational small molecule being developed for the treatment of hypothalamic obesity, a form of obesity that results from damage to the hypothalamus. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
LB54640 is a small molecule designed to address hypothalamic obesity, though its specific molecular target has not been disclosed. The drug is being studied for its ability to manage weight in patients with this condition, which is characterized by weight gain due to hypothalamic damage.
LB54640 is being developed by Rhythm Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RYTM. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with hypothalamic obesity.
LB54640 is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational, meaning it has not yet received approval from the U.S. Food and Drug Administration or other regulatory bodies for commercial use.
LB54640 has been studied in one completed Phase 2 clinical trial, identified as NCT06046443. This randomized, double-blind, placebo-controlled study enrolled 28 participants aged 12 years and older with hypothalamic obesity and was conducted in the United States and United Kingdom.
No alternative names for LB54640 have been reported. The drug is identified solely by its code name LB54640 in clinical trial registries and by its developer, Rhythm Pharmaceuticals.