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

NCT07520292 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-09

No results posted yet for this study

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

Interventions

DRUG

NTX-2001

Daily (QD) x 2 weeks.

DRUG

Placebo

Daily (QD) x 2 weeks.

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • Newleos Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-20
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07520292 on ClinicalTrials.gov