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New pill aims to curb heavy drinking: phase 2 trial results expected

NCT ID NCT06545916

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested whether the drug sunobinop (V117957) can reduce heavy drinking in adults with moderate to severe alcohol use disorder who want treatment. 209 participants took either sunobinop or a placebo daily for several weeks. The study measured changes in heavy drinking days and total drinks consumed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sunobinop (V117957)
What this could lead to
If successful, this could lead to a new medication that helps people with alcohol use disorder drink less heavily.
What could go wrong
This is a phase 2 trial, so it is still early. The drug may not work better than a placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

209 people

The number who actually took part.

Started

Oct 2024

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria include: * Male and female age ≥18 years. * Diagnosis of moderate or severe alcohol use disorder. * Currently seeking treatment for alcohol use disorder. * Has 4 or more heavy drinking days (HDD) in each of the 4 weeks prior to baseline visit. Key Exclusion Criteria include: * Subjects that meet current DSM-5 criteria for moderate or severe substance use disorder other than alcohol and nicotine. Other protocol-specific inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

alcohol abuse Alcohol Drinking

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Belmont Medical Office

    Brooklyn, New York, 11212, United States

  • Bio Terra Med SRL

    Bucharest, 010701, Romania

  • Cabinet Medical Individual Dr. Andreea Popa

    Bucharest, 050802, Romania

  • Cebis Usa, Llc

    Houston, Texas, 77074, United States

  • Inquest Clinical Research

    Baytown, Texas, 77521, United States

  • Ohio Clinical Trials

    Columbus, Ohio, 43212, United States

  • Spitalul Universitar De Urgenta Militar Central "Dr. Carol Davila"

    Bucharest, 010825, Romania

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