RecruitingPhase 1NCT07520292

Study of NTX-2001 on Alcohol Consumption in 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


Sponsor

Newleos Therapeutics, Inc.

Enrollment

50 participants

Start Date

Mar 20, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 21 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called NTX-2001 and a drug called Placebo for people with alcohol use disorder. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNTX-2001

Daily (QD) x 2 weeks.

DRUGPlacebo

Daily (QD) x 2 weeks.


Locations(1)

Yale University School of Medicine, Connecticut Mental Health Center

New Haven, Connecticut, United States

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NCT07520292


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