Recruiting
Phase 3

LB-102

Sponsor:

LB Pharmaceuticals Inc.

Code:

NCT07363577

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

LB-102 (50 mg tablet)

LB-102 (100 mg tablet)

Placebo

Study Details

Brief summary:

This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, study designed to evaluate the efficacy, safety, tolerability, and of LB-102 versus placebo for the treatment of adult patients with an acute exacerbation of schizophrenia.

Conditions

Schizophrenia

Study ID

NCT07363577

Start date

Mar 25, 2026

Status verified date

Jul, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Able to provide ICF
  • Willing to be hospitalized for duration of the study
  • Diagnosis of schizophrenia as defined by DSM-5
  • BMI - 18-40
  • PANSS 80-120

Exclusion Criteria:

  • Sexually active m/f not willing to adhere to highly effect birth control
  • Breast feeding
  • Increase in PANSS of > 20% between screening and baseline
  • History of resistant treatment to schizophrenia medications
  • DSM-5 diagnosis other than schizophrenia
  • Risk of suicidal behavior
  • Risk of violent or destructive behavior
  • Clinically significant tardive dyskinesia determined by a score of ≥3 on Item 8 of the AIMS at Screening
  • Score of ≥3 on the BARS global clinical assessment of akathisia at Screening
  • Insulin dependent diabetes
  • Known ischemic heart disease or any history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery
  • History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the patient

Study Design

Enrollment

456 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LB-102 (50 mg tablet)

• LB-102 50 mg given orally for 6 weeks

experimental: LB-102 (100 mg tablet)

LB-102 100 mg given orally for 6 weeks

placebo comparator: Placebo

Placebo given orally for 6 weeks

Interventions

LB-102 (50 mg tablet)

LB-102 oral tablet given for six weeks

LB-102 (100 mg tablet)

LB-102 oral tablet given for six weeks

Placebo

Placebo tablet given orally for six weeks

Primary outcome measure

  • Change from baseline to Week 6 on the Positive and Negative Syndrome Scale [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Branislav Mancevski, MD

212-605-0300clinicaltrials@lbpharma.us

Locations

Pillar Clinical Research

Recruiting

Bentonville, Arkansas, United States, 72712

Contacts

Fayz Hudefi, MD

479-367-2688studies@pillarhc.com

Pillar Clinical Research

Recruiting

Little Rock, Arkansas, United States, 72204

Contacts

Leslie Smith, MD

501-307-1919studies@pillarhc.com

Nichole Gutierrez

501-307-1919ngutierrez@pillarhc.com

Woodland International Research Group

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

Ashley Poole

501-221-8681apoole@ergclinical.com

ProScience Research Group

Recruiting

Culver City, California, United States, 90230

Contacts

Paola Aguirre

424-227-8127paola.aguirre@proscienceerg.com

CenExel

Recruiting

Garden Grove, California, United States, 92845

Contacts

Dakota Gainers

714-943-5874d.gainers@cenexel.com

Synergy San Diego

Recruiting

Lemon Grove, California, United States, 92064

Contacts

Corey Weise

619-303-6130cweise@ergclinical.com

Clinical Innovations, Inc.

Recruiting

Riverside, California, United States, 92506

Contacts

Evagelos Coskinas, MD, PhD

866-236-3935info@CenExel.com

Health Synergy Clinical Research

Recruiting

Boynton Beach, Florida, United States, 33426

Contacts

Katherine Grigelis

561-473-3472kat@hscresearch.com

Innovative Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

Melissa Rodco

305-722-8444mrodco@segaltrials.com

Luis Sotolongo

305-722-8444lsotolongo@segaltrials.com

Accelerated Clinical Trial

Recruiting

Snellville, Georgia, United States, 30078

Contacts

Alexis Melson

978-255-1041amelson@acceleratedclinicaltrials.org

Pillar Clinical Research

Recruiting

Chicago, Illinois, United States, 60641

Contacts

Roueen Rafeyan, MD

224-534-7332studies@pillarhc.com

Nicole Gutierrez

479-367-2688ngutierrez@pillarhc.com

Arch Clinical Trials

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Israa Diab

314-266-1243idiab@archclinicaltrials.com

Neuro-Behavioral Clinical Research

Recruiting

North Canton, Ohio, United States, 44720

Contacts

Crystal Blackford

330-493-1118cblackford@nb-cr.com

More Information

Sponsor

LB Pharmaceuticals Inc.

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • acute schizophrenia,
  • exacerbated acute schizophrenia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by LB Pharmaceuticals Inc. on 2026-07-27.