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

Clinical Trial20 Mar 2026Phase 3● 7/10i

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

Eli Lilly and Company

Orforglipron is being tested in women with stress urinary incontinence who have obesity or overweight in two phase 3 studies under a master protocol. The trials will enroll 1,000 participants with 58-week follow-up, comparing daily oral orforglipron to placebo. This represents a novel indication expansion for Eli Lilly's small-molecule GLP-1 beyond diabetes and weight management, targeting a large underserved population where weight loss could provide therapeutic benefit. This marks the first major GLP-1 trial in urological conditions, potentially opening a new market segment.

Strategic Signal

Eli Lilly is positioning orforglipron for urological indications before competitors, potentially creating a differentiated commercial narrative beyond metabolic health. This strategy mirrors how SGLT2 inhibitors expanded from diabetes to heart failure and kidney disease, establishing new revenue streams. If successful, this could support premium pricing and formulary positioning by addressing an unmet medical need where existing treatments are limited.

GLP-1OtherEli Lilly

Original Abstract

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. | Condition(s): Urinary Incontinence,Stress | Primary endpoint(s): Change from Baseline in Incontinence Episode Frequency (IEF) | Enrollment: 1,000 (estimated) | Phase: Phase 3 | Sponsor: Eli Lilly and Company | Expected completion: 2028-03 | Status: Recruiting | Last update: 2026-03-20

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