Alcohol Use DisorderPhase 1NCT07520292
Study of NTX-2001 on Alcohol Consumption in Alcohol Use Disorder
A Phase 1 study testing NTX-2001 in people with Alcohol Use Disorder, run by Newleos Therapeutics, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- NTX-2001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Has provided written informed consent for the study and is willing to comply with all requirements of the protocol
- English speaker
- Male or female, ≥21 and ≤60 years of age.
- Has a body mass index (BMI) 18 to 35 kg/m2 inclusive.
- Meets DSM-5 criteria for Alcohol Use Disorder (AUD) confirmed by Mini-International Neuropsychiatric Interview (MINI).
- If participant is of childbearing potential, must commit to practicing highly effective methods of birth control during the study and at least 14 days after the last dose.
Who cannot join
- Currently seeking alcohol treatment or have been in alcohol treatment within the past 6 months
- Reports disliking spirits (hard liquor)
- Current diagnosis of substance use disorder, except for tobacco use disorder or mild cannabis use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)
- Past or current diagnosis of schizophrenia spectrum or other psychotic disorder as defined by the DSM-5
- Receiving psychotropics regularly, except for a stable dose of an antidepressant for at least 2 months prior to Screening
- Is at risk for suicidal ideation as per C-SSRS
Show all 9Show fewer
- Has moderate or severe hepatic impairment
- Has moderate or severe renal impairment
- Women who are pregnant or women who are currently breastfeeding unless they plan to stop breastfeeding for the duration of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University School of Medicine, Connecticut Mental Health Center
New Haven, Connecticut, 06519
Yale University School of Medicine, Connecticut Mental Health, 978-780-5937, clinicaltrials@newleos.com
About this study
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
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
- Being tested
- NTX-2001, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTX-2001Drug
Daily (QD) x 2 weeks.
PlaceboDrug
Daily (QD) x 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| NTX-2001 | Experimental | Not described Receives: Drug: NTX-2001 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of drinks consumed during the alcohol drinking paradigm (ADP).
Measured: Day 0 to Day 14
Secondary outcomes (1)
Incidence and severity of treatment-emergent adverse events (TEAEs), vital signs, and clinical laboratory throughout the study.
Measured: Day 0 to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start20 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newleos Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520292
- Sponsor's protocol ID
- NTX-2001-101
- Status last verified
- Mar 2026
- First submitted
- 3 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07520292
- Acronym / sponsor ID
- NTX-2001-101
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Newleos Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NTX-2001 | Experimental | Drug: NTX-2001 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Has provided written informed consent for the study and is willing to comply with all requirements of the protocol
- English speaker
- Male or female, ≥21 and ≤60 years of age.
- Has a body mass index (BMI) 18 to 35 kg/m2 inclusive.
- Meets DSM-5 criteria for Alcohol Use Disorder (AUD) confirmed by Mini-International Neuropsychiatric Interview (MINI).
Key exclusion criteria (9 listed)
- Currently seeking alcohol treatment or have been in alcohol treatment within the past 6 months
- Reports disliking spirits (hard liquor)
- Current diagnosis of substance use disorder, except for tobacco use disorder or mild cannabis use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)
- Past or current diagnosis of schizophrenia spectrum or other psychotic disorder as defined by the DSM-5
- Receiving psychotropics regularly, except for a stable dose of an antidepressant for at least 2 months prior to Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTX-2001Daily (QD) x 2 weeks. | Drug | NTX-2001 |
| PlaceboDaily (QD) x 2 weeks. | Drug | Placebo |
Primary outcome
Number of drinks consumed during the alcohol drinking paradigm (ADP).
Time frame: Day 0 to Day 14
1 secondary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs), vital signs, and clinical laboratory throughout the study.
Time frame: Day 0 to Day 21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NTX-2001 in people with Alcohol Use Disorder, run by Newleos Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Newleos Therapeutics Clinical Trial Team (978-780-5937, clinicaltrials@newleos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of drinks consumed during the alcohol drinking paradigm (ADP). (time frame: Day 0 to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.