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Study of NTX-2001 on Alcohol Consumption in Alcohol Use Disorder
Sponsor: Newleos Therapeutics, Inc.
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
Conditions
Interventions
NTX-2001
Daily (QD) x 2 weeks.
Placebo
Daily (QD) x 2 weeks.
Locations (1)
Yale University School of Medicine, Connecticut Mental Health Center
New Haven, Connecticut, United States