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

April 3, 2026 updated by: Newleos Therapeutics, Inc.

The Effects of NTX-2001, a Novel TAAR1 Partial Agonist, on Alcohol Consumption in Adults With Alcohol Use Disorder: A Phase 1b, Randomized, Placebo-Controlled, Proof-of-Concept Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale University School of Medicine, Connecticut Mental Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Has provided written informed consent for the study and is willing to comply with all requirements of the protocol
  2. English speaker
  3. Male or female, ≥21 and ≤60 years of age.
  4. Has a body mass index (BMI) 18 to 35 kg/m2 inclusive.
  5. Meets DSM-5 criteria for Alcohol Use Disorder (AUD) confirmed by Mini-International Neuropsychiatric Interview (MINI).
  6. 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.

Exclusion Criteria:

  1. Currently seeking alcohol treatment or have been in alcohol treatment within the past 6 months
  2. Reports disliking spirits (hard liquor)
  3. 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)
  4. Past or current diagnosis of schizophrenia spectrum or other psychotic disorder as defined by the DSM-5
  5. Receiving psychotropics regularly, except for a stable dose of an antidepressant for at least 2 months prior to Screening
  6. Is at risk for suicidal ideation as per C-SSRS
  7. Has moderate or severe hepatic impairment
  8. Has moderate or severe renal impairment
  9. Women who are pregnant or women who are currently breastfeeding unless they plan to stop breastfeeding for the duration of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Daily (QD) x 2 weeks.
Experimental: NTX-2001
Drug: NTX-2001
Daily (QD) x 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of drinks consumed during the alcohol drinking paradigm (ADP).
Time Frame: Day 0 to Day 14
Day 0 to Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of treatment-emergent adverse events (TEAEs), vital signs, and clinical laboratory throughout the study.
Time Frame: Day 0 to Day 21
Day 0 to Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newleos Therapeutics, Inc.

Collaborators

Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTX-2001-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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