Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LY2624803 - Solution, LY2624803 - Capsules
LY2624803 · 4 trials · 5 indications
Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). Analysis of covariance (ANCOVA) Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
AUC from time 0, extrapolated to infinity, estimated for both LY2624803 and the metabolite LSN2797276.
Cmax estimated for both LY2624803 and the metabolite LSN2797276.
WASO was calculated as total time in awake epochs between sleep onset time (first stage 2 epoch) and the end of the primary recording period (8 hours after lights -off). Data presented are Geometric Least Squares (LS) means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.
| Arm | Type | Description |
|---|---|---|
| Period A | EXPERIMENTAL | 2-week double-blind placebo lead-in period. Period A is the first of four 2-week treatment periods. |
| Period B | EXPERIMENTAL | Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period B is the second of four 2-week treatment periods. |
| Period C | EXPERIMENTAL | Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period C is the third of four 2-week treatment periods. |
| Period D | EXPERIMENTAL | Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period D is the fourth of four 2-week treatment periods. |
| 6 mg LY2624803 Alone Morning Dosing | EXPERIMENTAL | Participants received 6 milligrams (mg) LY2624803 alone orally (po) at approximately 0800 hours following an overnight fast. |
| 6 mg LY2624803 Morning Dosing + Activated Charcoal | EXPERIMENTAL | Participants received 6 mg LY2624803 po at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola. |
| 6 mg LY2624803 Alone Evening Dosing | EXPERIMENTAL | Participants received 6 mg LY2624803 alone po at approximately 2200 hours following a 4-hour fast. |
| 0.1 milligrams (mg) LY2624803 | EXPERIMENTAL | Single dose of 0.1 mg LY2624803 administered orally in up to 2 of 4 treatment periods |
| 1.0 mg LY2624803 | EXPERIMENTAL | Single dose of 1.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods |
| 3.0 mg LY2624803 | EXPERIMENTAL | Single dose of 3.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods |
| 6.0 mg LY2624803 | EXPERIMENTAL | Single dose of 6.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods |
| Placebo | PLACEBO_COMPARATOR | Single dose of placebo administered orally in up to 1 of 4 treatment periods |
| 0.3 mg LY2624803 | EXPERIMENTAL | Single dose of 0.3 mg LY2624803 administered orally in up to 2 of 4 treatment periods. |
| 10 mg Zolpidem | ACTIVE_COMPARATOR | Single dose of 10 mg zolpidem administered orally in up to 1 of 4 treatment periods. |
| Name | Type | Description |
|---|---|---|
| LY2624803 | DRUG | 1 mg, oral capsule, once nightly before bedtime |
| Placebo | DRUG | matching placebo (capsule or tablet), once nightly before bedtime |
| zolpidem | DRUG | 5 or 10 mg, oral tablet, once nightly before bedtime |
| Activated Charcoal | OTHER | Administered po |
| LY2624803 - Solution | DRUG | Administered orally as reconstituted solution |
| LY2624803 - Capsule | DRUG | Administered orally as a capsule |
| Placebo - Solution | DRUG | Administered orally as solution |
| Placebo - Capsule | DRUG | Administered orally as a capsule |
| LY2624803 - Capsules | DRUG | Administered orally as capsules. |
| Zolpidem - Tablets | DRUG | Administered orally as tablets. |
| Placebo - Capsules | DRUG | Administered orally as capsules. |
| Placebo - Tablets | DRUG | Administered orally as tablets. |
Inclusion Criteria: * Patients must be between 18 and 85 years of age, with a stable living situation * Clinical diagnosis of either primary insomnia or "secondary" insomnia (comorbid with depression, anxiety, and/or medical illness) * Insomnia systems must be at least moderate in severity within t...
LY2624803 was studied for the treatment of insomnia, including transient insomnia, primary insomnia, and sleep initiation and maintenance disorders. It is an investigational small molecule that was developed by Eli Lilly and Company. It has not been approved for any indication and remains in clinical development.
LY2624803 targets the histamine H1 receptor, also known as HRH1. It acts as an antagonist at this receptor. By blocking HRH1, the compound was designed to promote sleep in people with insomnia. This mechanism is consistent with its development as a small molecule for sleep disorders.
LY2624803 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the clinical trials of LY2624803, including Phase 1 and Phase 2 studies in insomnia. The drug remains an investigational asset.
LY2624803 is in Phase 1 development. Although a Phase 2 efficacy study was completed, the drug has not advanced beyond early clinical testing and is not approved. It remains an investigational compound for insomnia.
LY2624803 has been evaluated in completed clinical trials. These include NCT01784614 in Japanese participants with transient insomnia, NCT01779830 in participants with transient insomnia in France, NCT01236105 on pharmacokinetics in healthy subjects, and NCT00784875, a Phase 2 efficacy study in chronic insomnia.
Yes, LY2624803 Solution and LY2624803 Capsules refer to the same investigational drug, LY2624803. These names describe different formulations of the compound. The drug was developed by Eli Lilly and Company for insomnia and related sleep disorders.