Study S002324

A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight

ClinicalTrials.gov record

Registration

Registration: NCT07202884
Acronym: RESTRAIN-SUI
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: RECRUITING
Enrollment: 1000
Start: 2025-09-30
Primary completion: 2028-03
Lead sponsor: Eli Lilly and Company
Conditions: Urinary Incontinence,Stress
Interventions: DRUG:Orforglipron; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: CTIS:2025-522514-23-00; OTHER:J2A-MC-GZPS; OTHER:J2A-MC-GZS1; OTHER:J2A-MC-GZS2; NIH:2025

Registered primary outcomes

Change from Baseline in Incontinence Episode Frequency (IEF) [Baseline, Week 52]

Linked records (0)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

No records link to this registration yet.