Study of Sunobinop on Alcohol Consumption in Alcohol Use Disorder

June 3, 2026 updated by: Knoa Pharma LLC

A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Evaluate Impact of Sunobinop (V117957) on Alcohol Consumption in Subjects Diagnosed With Moderate to Severe Alcohol Use Disorder and Seeking Treatment

The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol consumption in subjects with alcohol use disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

209

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 010701
        • Bio Terra Med SRL
      • Bucharest, Romania, 010825
        • Spitalul Universitar De Urgenta Militar Central "Dr. Carol Davila"
      • Bucharest, Romania, 050802
        • Cabinet Medical Individual Dr. Andreea Popa
  • United States
    • New York
      • Brooklyn, New York, United States, 11212
        • Belmont Medical Office
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Ohio Clinical Trials
    • Texas
      • Baytown, Texas, United States, 77521
        • Inquest Clinical Research
      • Houston, Texas, United States, 77074
        • Cebis Usa, Llc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sunobinop
Drug: Sunobinop
1 tablet taken orally at bedtime
Other Names:
  • V117957
Placebo Comparator: Placebo to match sunobinop
Drug: Placebo to match sunobinop
1 tablet taken orally at bedtime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent heavy drinking days (HDD)
Time Frame: Day 57
Day 57

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of standard unit drinks
Time Frame: Day 57
Day 57
Percent of drinking days (PDD)
Time Frame: Day 57
Day 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Knoa Pharma LLC

Collaborators

Imbrium Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Actual)

May 5, 2026

Study Completion (Actual)

May 5, 2026

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUN2003A
  • 2024-517105-85-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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