Approval Probability
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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 being developed for the treatment of hypothalamic obesity, a form of obesity caused by damage to the hypothalamus. It is an investigational small molecule and has not been approved for any indication. Rhythm Pharmaceuticals is studying it in patients with this condition.
LB54640 targets the melanocortin 4 receptor, or MC4R. MC4R is a receptor in the brain that regulates appetite and energy balance. By acting on MC4R, LB54640 is designed to influence body weight regulation in patients with hypothalamic obesity.
LB54640 is being developed by Rhythm Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker RYTM. Rhythm is a biopharmaceutical company focused on rare diseases of energy balance, and LB54640 is part of its pipeline for hypothalamic obesity.
LB54640 is in Phase 2 clinical development. A Phase 2 trial in patients with hypothalamic obesity has been completed. The drug remains investigational and is not approved by the FDA or any other regulatory agency for any indication.
LB54640 has been studied in a Phase 2 trial, NCT06046443, titled A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity. The trial was randomized, double-blind, and placebo-controlled, enrolled 28 patients, and was conducted in the United States and United Kingdom.