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NCT06024642

Study of V117957 in Overactive Bladder Syndrome

Completed Phase 1 Results posted Last updated 26 June 2025
What this trial tests

Phase 1 trial testing V117957 in Overactive Bladder Syndrome in 51 participants. Completed in 21 May 2024.

Timeline
30 June 2022
Primary endpoint
21 May 2024
21 May 2024

Quick facts

Lead sponsorImbrium Therapeutics
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingtriple
Primary purposetreatment
Enrollment51
Start date30 June 2022
Primary completion21 May 2024
Estimated completion21 May 2024
Sites12 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Imbrium Therapeutics — full company profile →

Who can join

Adults 18 to 70, female only, with Overactive Bladder Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Number of Micturition Episodes per 24 hours
GroupValue95% CI
Week 2 (Placebo)-0.8± 1.97
Week 8 (V117957)-0.8± 2.32
Number of Incontinence Episodes per 24 hours
GroupValue95% CI
Week 2 (Placebo)-0.2± 0.60
Week 8 (V117957)-0.4± 0.81
Number of Urgency Episodes per 24 hours
GroupValue95% CI
Week 2 (Placebo)-0.5± 1.20
Week 8 (V117957)-0.5± 2.07

Adverse events — posted to ClinicalTrials.gov

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).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single-blind Run-in Period (Placebo)
Serious: 0/51 (0%)
Deaths: 0/51
Double-blind Treatment Phase (Placebo)
Serious: 0/50 (0%)
Deaths: 0/50
Double-blind Treatment Phase (V117957)
Serious: 0/48 (0%)
Deaths: 0/48
Safety Follow-up Phase (Placebo)
Serious: 1/47 (2%)
Deaths: 0/47

Serious adverse events (1 terms)

ReactionSystemSingle-blind Run-in Period…Double-blind Treatment Pha…Double-blind Treatment Pha…Safety Follow-up Phase (Pl…
CholelithiasisHepatobiliary disorders
Other adverse events (1 terms — click to expand)

ReactionSystemSingle-blind Run-in Period…Double-blind Treatment Pha…Double-blind Treatment Pha…Safety Follow-up Phase (Pl…
Urinary tract infectionInfections and infestations

Most-reported serious reactions: Cholelithiasis.

Data from ClinicalTrials.gov NCT06024642 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of V117957

Trials testing the same drug.

Other recruiting trials for Overactive Bladder Syndrome

Currently open trials in the same condition.

Other Imbrium Therapeutics trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06024642.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing