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Urinary Incontinence,stress / Orforglipron · Phase 3 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registry record for a Phase 3 randomized, placebo-controlled study of orforglipron in female participants with stress urinary incontinence and obesity or overweight. No results are posted. The planned primary outcome is change in incontinence episode frequency at week 52. Until results are published, no evidence of efficacy or safety can be assessed from this registration.
Phase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Urinary Incontinence,Stress; Female; age from 18 Years. Intervention: Orforglipron (GZS1); Orforglipron (GZS2). Compared with: Placebo (GZS1) — Placebo Comparator; Placebo (GZS2) — Placebo Comparator. n = 1,000. 136 sites across 10 countries.
This is a clinical trial registry record for a Phase 3 randomized, placebo-controlled study of orforglipron in female participants with stress urinary incontinence and obesity or overweight. No results are posted. The planned primary outcome is change in incontinence episode frequency at week 52. Until results are published, no evidence of efficacy or safety can be assessed from this registration.
Efficacy and safety outcomes are not yet available.
The source did not state who this applies to in practice.
This is a recruiting Phase 3 trial registration with no results posted; it describes planned enrollment and primary outcomes but contains no efficacy or safety data.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07202884). This is a study registration, not published results. Lead sponsor: Eli Lilly and Company. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1000 participants (ESTIMATED). Conditions: Urinary Incontinence,Stress. Interventions: DRUG: Orforglipron; DRUG: Placebo. Primary outcome measures: Change from Baseline in Incontinence Episode Frequency (IEF) , Baseline, Week 52. Brief summary: The GZPS master protocol will support two independent studies, J2A-MC-GZS1 and J2A-MC-GZS2. Each study will see how well and safely orforglipron works in adult female participants with stress urinary incontinence (SUI) who have obesity or overweight. SUI is leaking urine during movement or activity such as coughing or exercising. Participation in the study will last about 58 weeks from screening to safety follow-up.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.