NTX-2001 for reducing alcohol use in adults with alcohol use disorder

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

This study will test whether NTX-2001, a TAAR1 partial agonist, can reduce drinking and is safe in adults with alcohol use disorder.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 21 Years to 60 Years
• Sex: All
• Sponsor: Newleos Therapeutics, Inc. (Industry-sponsored)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT07520292 on ClinicalTrials.gov

What this trial studies

NTX-2001, a TAAR1 receptor partial agonist, is given daily for two weeks and compared with a matching placebo in adults with alcohol use disorder. This Phase 1b trial emphasizes safety and tolerability while collecting early data on alcohol consumption, with participants attending four clinic visits over a 10-week period. Eligible participants are adults aged 21–60 with DSM-5–confirmed AUD and BMI between 18 and 35 kg/m2, and those currently seeking formal alcohol treatment are excluded. The study is sponsored by Newleos Therapeutics and conducted in collaboration with Yale University School of Medicine.

Who should consider this trial

Good fit: Adults aged 21–60 with DSM-5–diagnosed alcohol use disorder, BMI 18–35 kg/m2, able to consent in English and attend the clinic visits in New Haven, CT, and not currently seeking alcohol treatment are the best candidates.

Not a fit: People actively seeking alcohol treatment, those with current non-nicotine substance use disorders or psychotic disorders, or those unable to travel to the Yale site are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, NTX-2001 could provide a new medication option to help reduce drinking and cravings in people with alcohol use disorder.

How similar studies have performed: TAAR1-targeting drugs represent a relatively new approach with supportive preclinical data and limited early human data, so applying this mechanism to alcohol use disorder is novel and not yet proven.

Eligibility criteria

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

Where this trial is running

New Haven, Connecticut

• Yale University School of Medicine, Connecticut Mental Health Center — New Haven, Connecticut, United States (Recruiting)

Study contacts

• Study coordinator: Newleos Therapeutics Clinical Trial Team

Conditions Alcohol Use Disorder