Recruiting
Phase 3

KarXT

Sponsor:

Bristol-Myers Squibb

Code:

NCT07140913

Conditions

Mania

Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Xanomeline/Trospium Chloride

Placebo

Study Details

Brief summary:

The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.

Conditions

Mania

Bipolar Disorder

Study ID

NCT07140913

Start date

Oct 8, 2025

Status verified date

Jun, 2026

Completion date

Jun 28, 2027

Anticipated

Primary completion date

Jun 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) version 7.0.2.
  • Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (≤ 3 weeks).
  • The individual requires hospitalization for the acute exacerbation or relapse of mania.
  • Body mass index ≥ 18 and ≤ 40 kg/m2.
  • Currently experiencing an acute episode of mania or mania with mixed features with a therapeutic dose of lithium, valproate, or lamotrigine. The dose of the mood stabilizer must have remained stable for at least two weeks prior to screening. Additionally, participants on valproate must have been receiving treatment with valproate for a minimum of seven months.
  • YMRS Total Score of ≥ 18 at Screening and at Baseline, and < 20% reduction in YMRS from screening to baseline.

Exclusion Criteria:

  • Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 at screening) including BP-I depression (for previous 3 months only), BP-I with rapid cycling, first manic episode, BP-II, primary psychotic disorder, borderline personality disorder, and major depressive disorder, with the exception of mild anxiety disorders.
  • Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 at screening), or current use as determined by urine toxicology screen or alcohol test.
  • Risk for suicidal behavior at screening as determined by the investigator's clinical assessment and the C-SSRS with an answer "Yes" to item 4 or 5 within 6 months before screening or between screening and baseline, or "Yes" to any of the 5 items (C-SSRS behavior) with an event occurring within the 12 months before screening, or between screening and baseline.
  • History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months.
  • History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
  • Participants with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or the LFT results.
  • Elevations in hepatic transaminases at screening ≥ 2 × ULN for ALT or AST and/or bilirubin > 1.5× ULN, unless in the context of Gilbert's syndrome.
  • All grades of hepatic impairment (mild \[Child-Pugh Class A\], moderate \[Child-Pugh Class B\], and severe \[Child-Pugh Class C\]).
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Enrollment

424 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KarXT + Lithium, Valproate, or Lamotrigine

placebo comparator: Placebo + Lithium, Valproate, or Lamotrigine

Interventions

Xanomeline/Trospium Chloride

Specified dose on specified days

Placebo

Specified dose on specified days

Primary outcome measure

  • Change from baseline in Young Mania Rating Scale (YMRS) at Week 5 [ Time Frame: At Week 5 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Pillar Clinical Research - Bentonville

Recruiting

Bentonville, Arkansas, United States, 72712

Contacts

Fayz Hudefi, Site 0029

479-367-2688

Pillar Clinical Research- Little Rock

Recruiting

Little Rock, Arkansas, United States, 72204

Contacts

Leslie Smith, Site 0018

501-350-3285

Clinical Innovations, Inc. dba CITrials

Recruiting

Bellflower, California, United States, 90706

Contacts

Gerald Maguire, Site 0110

562-249-6956

Inland Psychiatric Medical Group.

Recruiting

Chino, California, United States, 91710

Contacts

Nandita Puchakayala, Site 0049

909-488-9116

Proscience Research Group

Recruiting

Culver City, California, United States, 90230

Contacts

Marina Bussel, Site 0014

424-227-8127

Omega Clinical Trials - La Habra

Recruiting

La Habra, California, United States, 90631

Contacts

Wakelin McNeel, Site 0151

562-690-2200

Catalina Research Institute, LLC

Recruiting

Montclair, California, United States, 91763

Contacts

Stephen Volk, Site 0037

909-590-8409

NRC Research Institute

Recruiting

Orange, California, United States, 92868

Contacts

Tony Ortiz, Site 0148

714-289-1100

Clinical Innovations, Inc. dba CITrials

Recruiting

Riverside, California, United States, 92506

Contacts

Evagelos Coskinas, Site 0106

951-300-4924

Velocity Clinical Research, Hallandale Beach

Recruiting

Hallandale, Florida, United States, 33009

South Florida Research Phase I-IV

Recruiting

Miami, Florida, United States, 33166

Contacts

Silvia Silva Duluc, Site 0021

305-669-6166

Health Synergy Clinical Research

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

Mohammad Nisar, Site 0016

786-831-7303

CenExel iResearch, LLC

Recruiting

Savannah, Georgia, United States, 31405

Contacts

Yael Elfassy, Site 0136

912-744-0800

Pillar Clinical Research -Chicago

Recruiting

Chicago, Illinois, United States, 60641

Contacts

Roueen Rafeyan, Site 0017

312-865-6336

Arch Clinical Trials

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Junaid Syed, Site 0023

314-771-6387

Richmond Behavioral Associates

Recruiting

Staten Island, New York, United States, 10314

Contacts

Peter Weiden, Site 0032

917-701-7484

Community Clinical Research

Recruiting

Austin, Texas, United States, 78754

Contacts

David Brown, Site 0026

512-323-2622

Elevate Clinical Research-Houston

Recruiting

Houston, Texas, United States, 77058

Prime Clinical Research - Mansfield

Recruiting

Mansfield, Texas, United States, 76063

Contacts

Jamie Alexander, Site 0156

817-907-7330

Pillar Clinical Research - Richardson

Recruiting

Richardson, Texas, United States, 75080

Contacts

Scott Bartley, Site 0033

214-396-4844

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Bipolar-I Disorder
  • Mania
  • KarXT
  • adjunctive treatment
  • mood stabilizer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-06-23.