Study of Sunobinop on Alcohol Consumption in Alcohol Use Disorder

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06545916

Enrollment

209

Registered

2024-08-09

Start date

2024-10-14

Completion date

2026-05-05

Last updated

2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

Keywords

Alcohol consumption, Moderate to severe alcohol use disorder

Brief summary

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

Interventions

DRUGSunobinop

1 tablet taken orally at bedtime

DRUGPlacebo to match sunobinop

1 tablet taken orally at bedtime

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Percent heavy drinking days (HDD)	Day 57

Secondary

Measure	Time frame
Number of standard unit drinks	Day 57
Percent of drinking days (PDD)	Day 57

Countries

Romania, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026