Alcohol Use DisorderPhase 2NCT06545916
Study of Sunobinop on Alcohol Consumption in Alcohol Use Disorder
A Phase 2 study testing Sunobinop in people with Alcohol Use Disorder, run by Knoa Pharma LLC at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Sunobinop
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 209 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 14 Oct 2024to 5 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States4 sites
Inquest Clinical Research
Baytown, Texas, 77521
Belmont Medical Office
Brooklyn, New York, 11212
Ohio Clinical Trials
Columbus, Ohio, 43212
Cebis Usa, Llc
Houston, Texas, 77074
Romania3 sites
Bio Terra Med SRL
Bucharest, 010701
Spitalul Universitar De Urgenta Militar Central "Dr. Carol Davila"
Bucharest, 010825
Cabinet Medical Individual Dr. Andreea Popa
Bucharest, 050802
About this study
Official title: 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
The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol consumption in subjects with alcohol use disorder.
- Conditions
- Alcohol Use Disorder
- Being tested
- Sunobinop, Placebo to match sunobinop
- Keywords
- Alcohol consumption, Moderate to severe alcohol use disorder
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunobinopDrug
Also called V117957
1 tablet taken orally at bedtime
Placebo to match sunobinopDrug
1 tablet taken orally at bedtime
| Study group | Role | What they receive |
|---|---|---|
| Sunobinop | Experimental | Not described Receives: Drug: Sunobinop |
| Placebo to match sunobinop | Placebo comparator | Not described Receives: Drug: Placebo to match sunobinop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent heavy drinking days (HDD)
Measured: Day 57
Secondary outcomes (2)
Number of standard unit drinks
Measured: Day 57
Percent of drinking days (PDD)
Measured: Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start14 Oct 2024
- Primary completion5 May 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Knoa Pharma LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Imbrium Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545916
- Sponsor's protocol ID
- SUN2003A
- Other IDs
- 2024-517105-85-00
- Status last verified
- Jun 2026
- First submitted
- 6 Aug 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06545916
- Acronym / sponsor ID
- SUN2003A
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol consumption, Moderate to severe alcohol use disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Knoa Pharma LLCIndustry (pharma, biotech, devices)
- Collaborators
- Imbrium Therapeutics
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol consumption in subjects with alcohol use disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sunobinop | Experimental | Drug: Sunobinop |
| Placebo to match sunobinop | Placebo comparator | Drug: Placebo to match sunobinop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SunobinopAlso: V1179571 tablet taken orally at bedtime | Drug | Sunobinop |
| Placebo to match sunobinop1 tablet taken orally at bedtime | Drug | Placebo to match sunobinop |
Primary outcome
Percent heavy drinking days (HDD)
Time frame: Day 57
2 secondary outcomes
Number of standard unit drinks
Time frame: Day 57
Percent of drinking days (PDD)
Time frame: Day 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunobinop in people with Alcohol Use Disorder, run by Knoa Pharma LLC at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent heavy drinking days (HDD) (time frame: Day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.