Clinical trials

9

Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Study to Assess Safety and Tolerability of KarXT With Administration of Antiemetics in Healthy Volunteers

This study looks at how to reduce nausea and vomiting in people taking KarXT which is used to treat mental health conditions like schizophrenia. KarXT can cause stomach-related side effects, especially in the first couple of weeks. In this study, healthy volunteers will take KarXT along with anti-nausea medication, either regularly (to prevent symptoms) or as needed. The goal is to see how well these strategies help reduce nausea and vomiting and how safe the combination is. The results will help doctors better manage side effects and make treatment more comfortable for patients starting KarXT.

Participants needed: 225
Trial details
Phase: Phase 4Age: 18-65Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: Jul 2, 2026
Eligibility criteria

Participants must be healthy male and female participants as determined by no cl... [+3]

Participants must not have history or presence of clinically significant cardiov... [+4]

Status: Recruiting

A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively

The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively

Participants needed: 400
Trial details
Phase: Phase 3Age: 5-17Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: Jun 23, 2026Locations: 58
Eligibility criteria

Participants must not have a significant risk of committing violent acts, seriou... [+3]

Status: Recruiting

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.

Participants needed: 500
Trial details
Phase: Phase 3Age: 55-90Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: Jun 16, 2026Locations: 154
Eligibility criteria

Is a male or female aged 55 to 90 years, inclusive, at Screening. [+10]

Psychotic symptoms that are primarily attributable to a condition other than the... [+9]

Status: Recruiting

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.

Participants needed: 800
Trial details
Phase: Phase 3Age: 55-90Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: Jun 16, 2026Locations: 428
Eligibility criteria

Must have completed study CN012-0026, CN012-0027 or CN012-0056. [+4]

Significant or severe medical conditions that, in the opinion of the Investigato... [+3]

Status: Recruiting

A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin

The purpose of this study is to evaluate the effects of KarXT administration on the drug levels of midazolam, fexofenadine, and digoxin in healthy adult participants.

Participants needed: 60
Trial details
Phase: Phase 1Age: 18-50Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: Jun 11, 2026Locations: 1
Eligibility criteria

Participants must be healthy male and female (INOCBP) as determined by no clinic... [+1]

Participants must not have organ dysfunction or any clinically significant devia... [+9]

Status: Recruiting

A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

Participants needed: 406
Trial details
Phase: Phase 3Age: 55-90Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: Jun 10, 2026Locations: 289
Eligibility criteria

Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Vis... [+3]

Status: Recruiting

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)

This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

Participants needed: 410
Trial details
Phase: Phase 3Age: 55-90Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: May 4, 2026Locations: 116
Eligibility criteria

Is aged 55 to 90 years, inclusive, at Screening [+11]

Psychotic symptoms that are primarily attributable to a condition other than the... [+24]

Status: Recruiting

An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

This is a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment period (Visit 8/Day 42 ± 3) of ARISE Study (KAR-012). The primary objective of the study is to assess the long-term safety and tolerability of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily \[BID\]) in subjects with schizophrenia.

Participants needed: 280
Trial details
Phase: Phase 3Age: 18-65Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: Mar 11, 2026Locations: 175
Eligibility criteria

Subject is aged ≥18 to <66 years at the time of randomization of Study KAR-012 [+7]

Subject answers "Yes" to "suicidal ideation" Item 4 (active suicidal ideation wi... [+13]

Status: Recruiting

A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants

The purpose of this study is to evaluate the pharmacokinetics (PK) of xanomeline following administration of KarXT in CYP2D6 normal/extensive, intermediate, poor, and ultrarapid metabolizers.

Participants needed: 56
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: Feb 19, 2026Locations: 3
Eligibility criteria

Participant must be healthy male and female (INOCBP) participants as determined... [+2]

Participants must not have evidence of organ dysfunction or any clinically signi... [+1]