Recruiting

Sunobinop for Alcohol Use Disorder

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What is being tested

Sunobinop

+ Placebo to match sunobinop

Drug
Who is being recruted

Alcohol Drinking+5

+ Alcoholism

+ Behavior

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: October 2024
See protocol details

Summary

Principal SponsorImbrium Therapeutics
Study ContactMedical Information
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 14, 2024

Actual date on which the first participant was enrolled.

This study aims to determine if a medication named Sunobinop can help reduce alcohol consumption in individuals diagnosed with moderate to severe alcohol use disorder. The study focuses on people who are actively seeking treatment for their alcohol use, which is important because finding effective treatments can help improve the quality of life for those struggling with this condition. By potentially offering a new way to manage alcohol use, the study could provide an important tool for individuals and healthcare providers. Participants in this study will be randomly assigned to receive either the medication Sunobinop or a placebo, which is a substance with no active ingredients, to compare the effects on their alcohol consumption. This is done in a "double-blind" manner, meaning neither the participants nor the researchers know who is receiving the actual medication, ensuring unbiased results. The study observes how well Sunobinop works in reducing alcohol intake and monitors any side effects to ensure the treatment is safe. This careful approach helps researchers understand if Sunobinop can be a beneficial treatment for those with alcohol use disorder.

Official TitleA 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
NCT06545916
Principal SponsorImbrium Therapeutics
Study ContactMedical Information
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alcohol DrinkingAlcoholismBehaviorMental DisordersDrinking BehaviorSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced Disorders

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Recruiting

Belmont Medical Office

Brooklyn, United StatesOpen Belmont Medical Office in Google Maps
Recruiting

Ohio Clinical Trials

Columbus, United States
Recruiting

Inquest Clinical Research

Baytown, United States
Recruiting

Cebis Usa, Llc

Houston, United States
Recruiting
7 Study Centers