NCT01354353 is a Phase 1 clinical trial of LY2140023 in Schizophrenia, sponsored by Denovo Biopharma LLC.

Who is sponsoring NCT01354353?

NCT01354353 is sponsored by Denovo Biopharma LLC.

What drugs are being tested in NCT01354353?

Interventions in NCT01354353: LY2140023, Aripiprazole.

What condition does NCT01354353 study?

NCT01354353 studies Schizophrenia.

Is NCT01354353 still recruiting?

NCT01354353 is currently completed. Last updated 15 August 2022.

Are results published for NCT01354353?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-08-15 · How we verify

NCT01354353

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Tolerability of Multiple Ascending Doses of LY2140023 in Subjects With Schizophrenia

Completed Phase 1 Results posted Last updated 15 August 2022

What this trial tests

Phase 1 trial testing LY2140023 in Schizophrenia in 75 participants. Completed in 1 March 2012.

Timeline

1 May 2011

Primary endpoint
1 March 2012

1 March 2012

Quick facts

Lead sponsor	Denovo Biopharma LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	75
Start date	1 May 2011
Primary completion	1 March 2012
Estimated completion	1 March 2012
Sites	2 locations across United States

Drugs / interventions tested

LY2140023 — full drug profile →
Aripiprazole (aripiprazole) — full drug profile →

Conditions studied

Schizophrenia — all drugs for Schizophrenia →

Sponsor

Denovo Biopharma LLC — full company profile →

Who can join

Adults 18 to 65, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests)
Time frame: Baseline up to Day 21 for Part A
Participants with at least 1 postdose (Day 10 through the end of study visit \[Day 21\]) treatment emergent adverse event (TEAE) were counted by dose cohort. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Sponsor's own description

This is an inpatient, open-label, multiple-dose, multicenter study to evaluate the safety and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated therapeutic exposure under clinical investigation. In the event of poor tolerability in Part A of this study Part B may be conducted to explore higher doses using titration. Participants in both Parts A and B will participate in a 9 day wash-out period of current medication (Study Days 1-9); participants coming into the study on aripiprazole will remain on their current therapy throughout.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

G protein-coupled receptors in neurodegenerative diseases and psychiatric disorders.
Wong TS, Li G, Li S, Gao W, et al · · 2023 · cited 113× · PMID 37137892 · DOI 10.1038/s41392-023-01427-2

Verify or expand the search:

Other trials of LY2140023

Trials testing the same drug.

NCT00149292 — Study of LY2140023 in Schizophrenia Comparing LY2140023, Olanzapine, and Placebo · Phase 2 · completed

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting

Other Denovo Biopharma LLC trials

Trials by the same sponsor.

NCT05113771 — A Biomarker-Guided, Randomized, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients With TRD · Phase 2 · completed
NCT03776071 — A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Gliobla · Phase 3 · completed
NCT03263026 — Study to Assess Enzastaurin + R-CHOP in Subjects With DLBCL With the Genomic Biomarker DGM1™ · Phase 3 · completed
NCT00149292 — Study of LY2140023 in Schizophrenia Comparing LY2140023, Olanzapine, and Placebo · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01354353 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Denovo Biopharma LLC
Last refreshed: 15 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01354353.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing