Study of NTX-2001 on Alcohol Consumption in Alcohol Use Disorder

NCT07520292 | Recruiting Phase 1 FDA Drug

• 1 other identifier: NTX-2001-101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this Phase 1b clinical trial is to evaluate the effects of a novel TAAR1 receptor partial agonist (NTX-2001) in adults with Alcohol Use Disorder (AUD). The main questions this trial aims to answer are:

• Does NTX-2001 affect alcohol consumption in adults with AUD?
• Is NTX-2001 safe and well tolerated in adults with AUD? Researchers will compare the effects of NTX-2001 with matching placebo (look-alike capsule that contains no drug). Participants will:
• Take NTX-2001 or matching placebo every day for 2 weeks
• Visit the clinic 4 times over the course of 10 weeks

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Number of drinks consumed during the alcohol drinking paradigm (ADP).

  Day 0 to Day 14

Secondary Outcomes (1)

• Incidence and severity of treatment-emergent adverse events (TEAEs), vital signs, and clinical laboratory throughout the study.

  Day 0 to Day 21

Study Arms (2)

NTX-2001

EXPERIMENTAL

Drug: NTX-2001

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

NTX-2001 DRUG

Daily (QD) x 2 weeks.

NTX-2001

Placebo DRUG

Daily (QD) x 2 weeks.

Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Has provided written informed consent for the study and is willing to comply with all requirements of the protocol
• English speaker
• Male or female, ≥21 and ≤60 years of age.
• Has a body mass index (BMI) 18 to 35 kg/m2 inclusive.
• Meets DSM-5 criteria for Alcohol Use Disorder (AUD) confirmed by Mini-International Neuropsychiatric Interview (MINI).
• If participant is of childbearing potential, must commit to practicing highly effective methods of birth control during the study and at least 14 days after the last dose.

You may not qualify if:

• Currently seeking alcohol treatment or have been in alcohol treatment within the past 6 months
• Reports disliking spirits (hard liquor)
• Current diagnosis of substance use disorder, except for tobacco use disorder or mild cannabis use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)
• Past or current diagnosis of schizophrenia spectrum or other psychotic disorder as defined by the DSM-5
• Receiving psychotropics regularly, except for a stable dose of an antidepressant for at least 2 months prior to Screening
• Is at risk for suicidal ideation as per C-SSRS
• Has moderate or severe hepatic impairment
• Has moderate or severe renal impairment
• Women who are pregnant or women who are currently breastfeeding unless they plan to stop breastfeeding for the duration of the study

Sponsors & Collaborators

• Newleos Therapeutics, Inc.: lead
• Yale University: collaborator

Study Sites (1)

Yale University School of Medicine, Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Newleos Therapeutics Clinical Trial Team

CONTACT

978-780-5937; clinicaltrials@newleos.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 9, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)