Phase 3 Schizophrenia Trial, Recruiting NCT07363577 Sponsor: LB Pharmaceuticals Inc. Condition: Schizophrenia
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Phase 3 Schizophrenia Trial, Recruiting

NCT07363577
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are able to give written consent to participate in the study
  • People who are willing to stay in hospital for the entire duration of the study
  • People who have been diagnosed with schizophrenia according to DSM-5 diagnostic standards
  • People whose Body Mass Index (a measure of body weight relative to height) falls between 18 and 40
  • People whose symptom severity score on a standard schizophrenia rating scale (called the PANSS) falls between 80 and 120 at the time of assessment

Who may not be able to join:

  • Sexually active people (male or female) who are not willing to use highly effective contraception during the study
  • People who are currently breastfeeding
  • People whose PANSS symptom score increases by more than 20% between their initial screening appointment and their baseline appointment
  • People who have a history of schizophrenia that has not responded to standard schizophrenia medications
  • People who have a DSM-5 diagnosis other than schizophrenia
  • People considered to be at risk of suicidal behaviour
  • People considered to be at risk of violent or destructive behaviour
  • People with significant involuntary movement problems (tardive dyskinesia), based on a specific assessment score at screening (confirm with trial site)
  • People with significant restlessness or inability to sit still (akathisia), based on a specific assessment score at screening (confirm with trial site)
  • People with insulin-dependent diabetes
  • People with known heart disease, or any history of heart attack, heart failure, angioplasty, stenting, or heart bypass surgery
  • People with a significant history or current condition affecting the heart, lungs, liver, kidneys, blood, digestive system, hormones, immune system, skin, nervous system, or cancer — or any other condition the trial doctor considers a safety concern

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 212-605-0300

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
LB Pharmaceuticals Inc.
Registry
ClinicalTrials.gov
Start date
25 March 2026
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change from baseline to Week 6 on the Positive and Negative Syndrome Scale

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov