Recruiting
Phase 1

NTX-2001

Sponsor:

Newleos Therapeutics, Inc.

Code:

NCT07520292

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Not accepted

Interventions

NTX-2001

Placebo

Study Details

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

Study ID

NCT07520292

Start date

Mar 20, 2026

Status verified date

Mar, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NTX-2001

placebo comparator: Placebo

Interventions

NTX-2001

Daily (QD) x 2 weeks.

Placebo

Daily (QD) x 2 weeks.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Newleos Therapeutics Clinical Trial Team

978-780-5937clinicaltrials@newleos.com

Locations

Yale University School of Medicine, Connecticut Mental Health Center

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Yale University School of Medicine, Connecticut Mental Health

978-780-5937clinicaltrials@newleos.com

More Information

Sponsor

Newleos Therapeutics, Inc.

Last update posted

Apr 9, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Newleos Therapeutics, Inc. on 2026-04-09.