Phase 1
N=51
Study of V117957 in Overactive Bladder Syndrome
Overactive Bladder Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT06024642 ↗Enrolled (actual)
51
Serious AEs
0.5%
Results posted
Jun 2025
Primary outcome: Primary: Change From Baseline in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours. — -0.8; -0.8; -0.2; -0.4 Episodes per 24 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- V117957 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Imbrium Therapeutics
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Micturition Episode Components (Micturition, Incontinence, and Urgency) Per 24 Hours. |
-0.8; -0.8; -0.2; -0.4; -0.5; -0.5 | — |
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.
Eligibility Criteria
Key Inclusion Criteria include:
- 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 include:
- 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.
Data sourced from ClinicalTrials.gov (NCT06024642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.