NCT07520292

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Newleos Therapeutics, Inc. · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	NTX-2001	Daily (QD) x 2 weeks.
DRUG	Placebo	Daily (QD) x 2 weeks.

Timeline

• Start date: 2026-03-20
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study