Recruiting
Phase 3

LB-102

Sponsor:

LB Pharmaceuticals Inc.

Code:

NCT07369154

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

LB-102

Study Details

Brief summary:

Phase 3, open label, multicenter study designed to assess the long term safety and tolerability of LB-102 for the treatment of adult patients with stable schizophrenia

Conditions

Schizophrenia

Study ID

NCT07369154

Start date

Apr 23, 2026

Status verified date

Jul, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provide ICF
  • Patients clinically stable PANSS </= 70 at screening
  • CGI-S </+ 3 at screening
  • Medically stable
  • BMI 18 -40
  • Taking oral antipsychotic treatment for at least 30 days
  • Have stable living environment

Exclusion Criteria:

  • Sexually active M/F patients not willing to use highly effective contraception
  • Breast feeding
  • History of treatment resistance to schizophrenia medications
  • DSM-5 current diagnosis other than schizophrenia
  • Risk of suicidal behavior
  • History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other

Study Design

Enrollment

900 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: LB-102

An open label study

Interventions

LB-102

LB-102 flexible dosing 50 mg - 100 mg

Primary outcome measure

  • Evaluate long term safety and tolerability of LB-102 by evaluating the number of adverse event, incidence of treatment emergent events. [ Time Frame: 52 weeks ]

Central Contacts and Locations

Central contacts

Locations

Chandler Clinical Trials

Recruiting

Chandler, Arizona, United States, 85224

Contacts

Pillar Clinical Research

Recruiting

Bentonville, Arkansas, United States, 72712

Contacts

Principal Investigator:

Fayz Hudefi, MD

Pillar Clinical Research

Recruiting

Little Rock, Arkansas, United States, 72204

Contacts

Principal Investigator:

Leslie Smith, MD

Woodland International Research Group

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

Advanced Research Center

Recruiting

Anaheim, California, United States, 92805

Contacts

Synapse Clinical Trials

Recruiting

Cerritos, California, United States, 90703

Contacts

ProScience Research Group

Recruiting

Culver City, California, United States, 90230

Contacts

CenExel

Recruiting

Culver City, California, United States, 92845

Contacts

Synergy San Diego

Recruiting

San Diego, California, United States, 92064

Contacts

CenExel

Recruiting

Hollywood, Florida, United States, 33024

Contacts

Principal Investigator:

Edwin Gomez, MD

Segal Trials

Recruiting

Miami Lakes, Florida, United States, 33063

Contacts

Health Synergy Clinical Research

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

CenExel

Recruiting

Atlanta, Georgia, United States, 30331

Contacts

Accelerated Clinical Trial

Recruiting

Snellville, Georgia, United States, 30078

Contacts

Pillar Clinical Research

Recruiting

Chicago, Illinois, United States, 60641

Contacts

Principal Investigator:

Roueen Rafeyan, MD

CenExel Gaithersburg

Recruiting

Gaithersburg, Maryland, United States, 20877

Contacts

Arch Clinical Trials

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Redbird Research

Recruiting

Las Vegas, Nevada, United States, 89119

Contacts

Neuro-Behavioral Clinical Research

Recruiting

New York, New York, United States, 11516

Contacts

Neuro-Behavioral Clinical Research

Recruiting

Canton, Ohio, United States, 44720

Contacts

Adams Clinical

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Adams Clinical

Recruiting

DeSoto, Texas, United States, 75115

Contacts

Pillar Clinical Research

Recruiting

Richardson, Texas, United States, 75080

Contacts

More Information

Sponsor

LB Pharmaceuticals Inc.

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

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.