Study of Sunobinop on Alcohol Consumption in Alcohol Use Disorder

Imbrium Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Alcohol Use Disorder

Treatments: Drug: Sunobinop; Drug: Placebo to match sunobinop

Study type: Interventional

Funder types: Industry

Identifiers

NCT06545916

2024-517105-85-00 (EU Trial (CTIS) Number)

SUN2003A

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Sunobinop

Experimental group

Treatment:

Drug: Sunobinop

Placebo to match sunobinop

Placebo Comparator group

Treatment:

Drug: Placebo to match sunobinop