Drugs / LY2140023

Trials 23

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 112 trials
Phase 1 NCT03321617 Apr 2018 → Mar 2020 — New York State Psychiatric Institute Completed No outcome recorded
Phase 1 NCT02919774 Oct 2016 → Apr 2018 — New York State Psychiatric Institute Completed No outcome recorded
Phase 1 NCT02234687 Sep 2014 → Feb 2016 post-traumatic stress disorder NYU Langone Health Terminated No outcome recorded
Phase 1 NCT01659177 Aug → Sep 2012 — Denovo Biopharma LLC Withdrawn No outcome recorded
Phase 1 NCT01637142 Jul 2012 — Denovo Biopharma LLC Completed No outcome recorded
Phase 1 NCT01606436 Jun → Aug 2012 schizophrenia Denovo Biopharma LLC Completed No outcome recorded
Phase 1 NCT01609218 Jun → Sep 2012 — Denovo Biopharma LLC Completed No outcome recorded
Phase 1 NCT01591330 Apr → Jun 2012 — Denovo Biopharma LLC Completed No outcome recorded
Phase 1 NCT01524237 Apr 2012 → Jul 2013 — Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT01475136 Nov 2011 → Dec 2012 liver disorder Denovo Biopharma LLC Completed No outcome recorded
Phase 26 trials · 1 met primary · 2 missed
Phase 2 NCT01125358 May 2010 → Sep 2012 schizophrenia Denovo Biopharma LLC Terminated No outcome recorded
Phase 2 NCT01086748 Mar 2010 → May 2012 schizophrenia Denovo Biopharma LLC Completed Missed primary
Phase 2 NCT01052103 Jan 2010 → Jun 2012 schizophrenia Denovo Biopharma LLC Completed Missed primary
Phase 2 NCT00845026 Mar 2009 → May 2010 schizophrenia Denovo Biopharma LLC Completed No outcome recorded
Phase 2 NCT00520923 Sep 2007 → Oct 2008 schizophrenia Denovo Biopharma LLC Completed No outcome recorded
Phase 2 NCT00149292 Aug 2005 → Jul 2006 schizophrenia Denovo Biopharma LLC Completed Met primary
Phase 2/31 trial
Phase 2/3 NCT01129674 Jun 2010 → Oct 2012 schizophrenia Denovo Biopharma LLC Terminated No outcome recorded
Phase 34 trials · 1 met primary · 1 missed
Phase 3 NCT01487083 Dec 2011 → Oct 2012 schizophrenia Denovo Biopharma LLC Terminated No outcome recorded
Phase 3 NCT01452919 Nov 2011 → Sep 2012 schizophrenia Denovo Biopharma LLC Completed No outcome recorded
Phase 3 NCT01328093 Apr 2011 → Oct 2012 schizophrenia Denovo Biopharma LLC Terminated Met primary
Phase 3 NCT01307800 Mar 2011 → Sep 2012 schizophrenia Denovo Biopharma LLC Terminated Missed primary

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2012-08-29 Eli Lilly and Company Results Lilly Stops Phase III Development of Pomaglumetad Methionil For the Treatment of Schizophrenia Based on Efficacy Results lilly.com ↗
The decision was made after a recently conducted independent futility analysis concluded HBBN, the second of Lilly's two pivotal studies, was unlikely to be positive in its primary efficacy endpoint if enrolled to completion.
2012-07-11 Eli Lilly and Company Results Lilly Announces Pomaglumetad Methionil Did Not Meet Primary Endpoint of Clinical Study lilly.com ↗
In study HBBM, pomaglumetad methionil did not separate from placebo in the primary efficacy endpoint in either the overall or predefined genetic subpopulation (based on the Positive and Negative Syndrome Scale, PANSS) at the two doses investigated (40 mg and 80 mg BID).
2009-03-29 Eli Lilly and Company Results Lilly Announces Inconclusive Phase II Study Results for mGlu2/3 at the International Congress on Schizophrenia Research lilly.com ↗
The primary analyses did not demonstrate that any of the four LY2140023 monohydrate doses (5, 20, 40 and 80 mg taken twice daily) separated from placebo.
2007-09-02 Eli Lilly and Company Results Investigational Agent Targeting Metabotropic Glutamate 2/3 Receptors Demonstrates Antipsychotic Activity in Humans, Study in Nature Medicine Finds lilly.com ↗
The study demonstrated that: -- LY2140023 and olanzapine showed statistically significant improvement versus placebo in PANSS (Positive and Negative Syndrome Scale), the most common scale used for measuring symptoms of patients with schizophrenia.

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 25 sources stand behind the page.

FieldValueCited text
Known as LY2140023 “The study will evaluate the effects of the mGluR2/3 partial agonist LY2140023 (Pomaglumetad Methionil, "POMA") at selected doses on ketamine-stimulated glutamate release in...” NCT02919774 ↗
19

NCT01328093 ↗

NCT01606436 ↗

NCT01354353 ↗

NCT01440478 ↗

NCT01475136 ↗

NCT00149292 ↗

NCT01086748 ↗

NCT01125358 ↗

NCT00520923 ↗

NCT01524237 ↗

Show 9 more sources

Known as LY2140023 Monohydrate “Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison.” PMID 24772351 ↗ Mar 2014
Known as POMA ClinicalTrials.gov intervention name — accepted as the source's own label NCT02919774 ↗
Known as pomaglumetad “We conducted an exploratory analysis of the existing clinical trial database of pomaglumetad methionil (pomaglumetad) to demonstrate treatment response in targeted patient populations.” PMID 25890643 ↗ Mar 2015
Known as pomaglumetad methionil “The study will evaluate the effects of the mGluR2/3 partial agonist LY2140023 (Pomaglumetad Methionil, "POMA") at selected doses on ketamine-stimulated glutamate release in...” NCT02919774 ↗
5

“Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison.” PMID 24772351 ↗ Mar 2014

“existing clinical trial database of pomaglumetad methionil (pomaglumetad) to demonstrate treatment response in targeted patient populations.” PMID 25890643 ↗ Mar 2015

NCT01487083 ↗

NCT02234687 ↗

NCT03321617 ↗

Action Activate “a receptor agonist that modulates the glutamatergic activity” NCT00149292 ↗
Route Oral “Administered orally” NCT00520923 ↗