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RECRUITING
NCT07520292
PHASE1

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

Sponsor: Newleos Therapeutics, Inc.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

21 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-03-20

Completion Date

2027-03

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

NTX-2001

Daily (QD) x 2 weeks.

DRUG

Placebo

Daily (QD) x 2 weeks.

Locations (1)

Yale University School of Medicine, Connecticut Mental Health Center

New Haven, Connecticut, United States