NCT06024642

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 26, 2025

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

1.9 years

First QC Date

August 17, 2023

Results QC Date

May 21, 2025

Last Update Submit

June 9, 2025

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, Weeks 2, and 8

Study Arms (2)

V117957

EXPERIMENTAL
Drug: V117957

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

V117957DRUG

V117957 1 mg - 1 tablet taken orally at bedtime.

Also known as: Sunobinop
V117957
PlaceboDRUG

Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Arizona Urology Specialists, PLLC

Tucson, Arizona, 85715, United States

Location

Hope Clinical Research, LLC

Canoga Park, California, 91303, United States

Location

ARK Clinical Research

Long Beach, California, 90815, United States

Location

Urology Group of Southern California

Los Angeles, California, 90017, United States

Location

Providea Health Partners, LLC

Evergreen Park, Illinois, 60805, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

Ochsner LSU Health Shreveport - Regional Urology

Shreveport, Louisiana, 71106, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Bay State Clinical Trials, Inc.

Watertown, Massachusetts, 02472, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Unified Women's Clinical Research-Lyndhurst

Winston-Salem, North Carolina, 27103, United States

Location

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, 19046, United States

Location

Results Point of Contact

Title
Clinical Leader
Organization
Imbrium Therapeutics L.P.
Medinfo@imbriumthera.com
1-888-827-0622

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2023

First Posted

September 6, 2023

Study Start

June 30, 2022

Primary Completion

May 21, 2024

Study Completion

May 21, 2024

Last Updated

June 26, 2025

Results First Posted

June 26, 2025

Record last verified: 2025-06

Locations

US(12)