Overactive Bladder SyndromePhase 1NCT06024642

Study of V117957 in Overactive Bladder Syndrome

A Phase 1 study testing V117957 in people with Overactive Bladder Syndrome, run by Imbrium Therapeutics at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with overactive bladder syndrome, compared to placebo. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Overactive Bladder Syndrome
What is being tested?: V117957
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 51 participants
Where: 12 sitesUnited States
Study dates: 30 Jun 2022to 21 May 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female, age ≥18-70 years and capable of voiding independently. Able to comply with acceptable methods of contraception.
Has symptoms of overactive bladder including (OAB) urinary urgency and urinary frequency with incontinence for ≥3 months.
Willing to modify current OAB treatment regimen.

Who cannot join

Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor.
Urinary tract infection (UTI) within past 30 days, or history of recurrent UTI.
Hematuria associated with bladder malignancy or other significant pathology.
Had surgical procedure that affected bladder function.
Received intravesical therapy within past 12 months or had bladder hydrodistention within past 6 months.
Grade III/IV pelvic organ prolapse with/without cystocele or urethral diverticulum.
Clinically significant kidney disease or nephrolithiasis.
Other protocol-specific inclusion and exclusion criteria may apply.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Boston Clinical Trials
Boston, Massachusetts, 02131
Hope Clinical Research, LLC
Canoga Park, California, 91303
Providea Health Partners, LLC
Evergreen Park, Illinois, 60805
AccuMed Research Associates
Garden City, New York, 11530
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046
ARK Clinical Research
Long Beach, California, 90815
Urology Group of Southern California
Los Angeles, California, 90017
DelRicht Research
New Orleans, Louisiana, 70115
Ochsner LSU Health Shreveport - Regional Urology
Shreveport, Louisiana, 71106
Arizona Urology Specialists, PLLC
Tucson, Arizona, 85715
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, 02472
Unified Women's Clinical Research-Lyndhurst
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects With Overactive Bladder Syndrome

The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with overactive bladder syndrome, compared to placebo.

Conditions: Overactive Bladder Syndrome
Being tested: V117957, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

V117957Drug
Also called Sunobinop
V117957 1 mg - 1 tablet taken orally at bedtime.
PlaceboDrug
Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.

Study groups in NCT06024642
Study group	Role	What they receive
V117957	Experimental	Not described Receives: Drug: V117957
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours.
Subjects were asked to record all micturition episode components into a daily electronic diary during the 3 to 7 days prior to each scheduled clinic visit.
Measured: Baseline, Weeks 2, and 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 202221 May 2024

First posted6 Sep 2023
Study start30 Jun 2022
Primary completion21 May 2024
Study completion21 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Overactive Bladder SyndromeStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06024642
Sponsor's protocol ID: OAG1030
Status last verified: Jun 2025
First submitted: 17 Aug 2023
Last updated: 26 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
Tensi+ for Treating Overactive Bladder
Overactive Bladder (OAB)
Not yet recruitingObservational study
Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice
Overactive Bladder Syndrome
Recruiting
Improving Overactive Bladder Treatment Access and Adherence
Overactive Bladder Syndrome, Urinary Incontinence

All Overactive Bladder Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects With Overactive Bladder Syndrome
ClinicalTrials.gov ID: NCT06024642
Acronym / sponsor ID: OAG1030
Conditions: Overactive Bladder Syndrome
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Imbrium TherapeuticsIndustry (pharma, biotech, devices)
Collaborators: Purdue Pharma LP
Study start: 30 Jun 2022 (actual)
Primary completion: 21 May 2024 (actual)
Study completion: 21 May 2024 (actual)
First posted: 6 Sep 2023 (actual)
Results: Posted 26 Jun 2025

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 safety, tolerability and efficacy of V117957 in subjects with overactive bladder syndrome, compared to placebo.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
V117957	Experimental	Drug: V117957
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Female, age ≥18-70 years and capable of voiding independently. Able to comply with acceptable methods of contraception.
Has symptoms of overactive bladder including (OAB) urinary urgency and urinary frequency with incontinence for ≥3 months.
Willing to modify current OAB treatment regimen.

Key exclusion criteria (8 listed)

Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor.
Urinary tract infection (UTI) within past 30 days, or history of recurrent UTI.
Hematuria associated with bladder malignancy or other significant pathology.
Had surgical procedure that affected bladder function.
Received intravesical therapy within past 12 months or had bladder hydrodistention within past 6 months.

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
V117957Also: SunobinopV117957 1 mg - 1 tablet taken orally at bedtime.	Drug	V117957
PlaceboPlacebo to match V117957 tablets - 1 tablet taken orally at bedtime.	Drug	Placebo

Primary outcome

Change From Baseline in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours.
Time frame: Baseline, Weeks 2, and 8
Subjects were asked to record all micturition episode components into a daily electronic diary during the 3 to 7 days prior to each scheduled clinic visit.

Results and safety

Results posted to the registry on 26 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	51	51

Primary outcome: Change From Baseline in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours.

Time frame: Baseline, Weeks 2, and 8. Mean (Standard Deviation). Unit: Episodes per 24 hours

Measure	Week 2 (Placebo) n = 47	Week 8 (V117957) n = 44
Number of Micturition Episodes per 24 hours	-0.8 (1.97)	-0.8 (2.32)
Number of Incontinence Episodes per 24 hours	-0.2 (0.60)	-0.4 (0.81)
Number of Urgency Episodes per 24 hours	-0.5 (1.20)	-0.5 (2.07)

Population analysed: The full analysis population is the group of subjects who were randomized, received study drug, and had at least 1 valid efficacy measurement.

Adverse events

Time frame: Adverse events (AEs) were reported starting from the time informed consent for study participation was provided up to 16 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 20 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single-blind Run-in Period (Placebo)	0 of 51 (0%)	3 of 51 (5.9%)	0 of 51
Double-blind Treatment Phase (Placebo)	0 of 50 (0%)	1 of 50 (2%)	0 of 50
Double-blind Treatment Phase (V117957)	0 of 48 (0%)	6 of 48 (12.5%)	0 of 48
Safety Follow-up Phase (Placebo)	1 of 47 (2.1%)	0 of 47 (0%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Overactive Bladder Syndrome

Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
Tensi+ for Treating Overactive Bladder
Overactive Bladder (OAB)
Not yet recruitingObservational study
Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice
Overactive Bladder Syndrome
Recruiting
Improving Overactive Bladder Treatment Access and Adherence
Overactive Bladder Syndrome, Urinary Incontinence

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.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing V117957 in people with Overactive Bladder Syndrome, run by Imbrium Therapeutics at 12 sites in United States.

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 3 inclusion and 8 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 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours. (time frame: Baseline, Weeks 2, and 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06024642.

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 26 Jun 2025.