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Also known as Pomaglumetad methionil
LY2140023 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 160 mg LY2140023 | EXPERIMENTAL | 80 mg LY2140023 administered orally, twice daily (BID) for up to 7 weeks. |
| 4 mg Risperidone | ACTIVE_COMPARATOR | 2 mg risperidone administered orally, BID for up to 7 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered orally, BID for up to 7 weeks. |
| 80 mg LY2140023 | EXPERIMENTAL | 40 mg LY2140023 administered orally, BID for up to 7 weeks. |
| 1 | EXPERIMENTAL | 160mg of LY2140023, taken orally as 80mg twice daily, for up to 4 weeks. |
| 2 | EXPERIMENTAL | 80mg of LY2140023, taken orally as 40mg twice daily, for up to 4 weeks. |
| 3 | EXPERIMENTAL | 40mg of LY2140023, taken orally as 20mg twice daily, for up to 4 weeks. |
| 4 | EXPERIMENTAL | 10mg of LY2140023, taken orally as 5mg twice daily, for up to 4 weeks. |
| 5 | PLACEBO_COMPARATOR | Placebo of LY2140023, taken orally twice daily, for up to 4 weeks. |
| 6 | ACTIVE_COMPARATOR | Placebo, taken orally every morning, followed by Olanzapine 15mg taken orally every evening for up to 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Risperidone | DRUG | Administered orally. |
| Placebo | DRUG | Administered orally. |
| LY2140023 | DRUG | Administered orally. |
| Olanzapine | DRUG | 10mg, PO (by mouth) QPM (every evening) for the first 3 days, then 15mg PO QPM, for up to 4 weeks. |
Inclusion Criteria: * Diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; APA 2000) (Disorganized, 295.10; Catatonic, 295.20; Paranoid 295.30; or Undifferentiated, 295.90) and confirmed by the Structured Clini...
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LY2140023 was studied as a treatment for schizophrenia. It is an investigational small molecule that Eli Lilly and Company evaluated in adults with schizophrenia. It has not been approved for marketing, and development reached Phase 2 before the program was discontinued.
LY2140023 was developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored both Phase 2 trials of the compound in schizophrenia, and no partner or out-licensing arrangement for the asset has been reported.
LY2140023 reached Phase 2. Two Phase 2 trials in schizophrenia were completed, and no trials are currently active. The compound is investigational and was not advanced into Phase 3 or submitted for regulatory approval.
LY2140023 was studied in two completed Phase 2 trials in schizophrenia. NCT01086748 enrolled 880 patients across the United States, Croatia, and Russia. NCT00520923 enrolled 654 patients across Argentina, Austria, Croatia, Germany, Mexico, Portugal, Romania, Russia, and South Africa. Both were randomized, double-blind, and placebo-controlled.
The two completed Phase 2 trials of LY2140023 enrolled a combined 1,534 patients with schizophrenia. NCT01086748 contributed 880 participants and NCT00520923 contributed 654. Both studies enrolled adults aged 18 years and older and included both male and female patients.
No. LY2140023 is an investigational drug and is not FDA approved. It completed Phase 2 development in schizophrenia under Eli Lilly and Company, with no active trials remaining, and it did not progress to regulatory submission.