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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517105-85-00
Acronym
SUN2023
Enrollment
100
Registered
2025-05-07
Start date
2025-05-26
Completion date
Unknown
Last updated
2025-10-03

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

Conditions

Alcohol use disorder (AUD).

Brief summary

Percent heavy drinking days (HDD) as assessed using Timeline Followback interview.

Detailed description

Number of standard unit drinks as assessed using Timeline Followback interview., Percent of days drinking (PDD) as assessed using Timeline Followback interview., WHO Risk Level of alcohol consumption as assessed using Timelines Followback interview.

Interventions

DRUGSunobinop 0.5 mg
DRUGSunobinop 2 mg
DRUGSunobinop 1 mg
DRUGV117957 Tablets Placebo - The placebo formulation has the same qualitative composition as the corresponding active formulation of V117957 Tablets
DRUGwith the absence of the API. The only difference in the dosage forms of V117957 Tablets and the placebo are that V117957 is replaced in the placebo tablet with an additional amount of microcrystalline cellulose.

Sponsors

Imbrium Therapeutics LP
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percent heavy drinking days (HDD) as assessed using Timeline Followback interview.

Secondary

MeasureTime frame
Number of standard unit drinks as assessed using Timeline Followback interview., Percent of days drinking (PDD) as assessed using Timeline Followback interview., WHO Risk Level of alcohol consumption as assessed using Timelines Followback interview.

Countries

Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026