Study of Sunobinop on Alcohol Consumption in Alcohol Use... | NCT06545916

Studies
Study of Sunobinop on Alcohol Consumption in Alcohol Use Disorder

NCT06545916

Sponsor

Knoa Pharma LLC

Status

Completed

Last Update Posted

Jun 5, 2026Actual

Enrollment

209Actual

Phase

Phase 2

Conditions

Alcohol Use Disorder

Interventions

Sunobinop
Placebo to match sunobinop

Countries

United States
Romania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2024-517105-85-00	EU Trial (CTIS) Number

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 14, 2024Actual

Primary Completion Date

May 5, 2026Actual

Completion Date

May 5, 2026Actual

First Submitted Date

Aug 6, 2024

First Submission Date that Met QC Criteria

Aug 6, 2024

First Posted Date

Aug 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2026

Last Update Posted Date

Jun 5, 2026Actual

Name	Class
Imbrium Therapeutics	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

209Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sunobinop	Experimental		Drug: Sunobinop
Placebo to match sunobinop	Placebo Comparator		Drug: Placebo to match sunobinop

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sunobinop	Drug	1 tablet taken orally at bedtime	Sunobinop	V117957

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Belmont Medical Office		Brooklyn	New York	11212	United States
Ohio Clinical Trials

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism
D000428	Alcohol Drinking

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided