A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight

Not Applicable

Not yet recruiting

• Conditions: Urinary Incontinence,Stress
• Interventions: Drug: Orforglipron; Drug: Placebo

• Registration Number: NCT07202884
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-24
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study Start: 2025-10-01
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2028-03
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• Have a body mass index (BMI) of 27 kilograms per square meter (kg/m2) or higher at screening
• Have a diagnosis of stress urinary incontinence

Exclusion Criteria

• Have had urinary incontinence surgery
• Have recently received onabotulinumtoxin A (Botox) bladder injections or currently taking medications for urinary incontinence
• Have given birth within one year of screening
• Have had a change in body weight of more than 11 pounds within 90 days prior to screening
• Have used any anti-obesity medication or alternative weight loss remedies within 180 days prior to screening
• Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
• Have had a cardiovascular health condition within 90 days prior to screening
• Are pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed for the duration of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orforglipron (GZS1)	Orforglipron	Participants will receive orforglipron orally
Placebo (GZS1)	Placebo	Participants will receive placebo orally
Orforglipron (GZS2)	Orforglipron	Participants will receive orforglipron orally
Placebo (GZS2)	Placebo	Participants will receive placebo orally

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Incontinence Episode Frequency (IEF)	Baseline, Week 52

Secondary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Weight	Baseline, Week 52
Change from Baseline in Urinary Incontinence-Specific Quality of Life	Baseline, Week 52
Change from Baseline in Number of Continence Pad (CAPD) Used Per Week	Baseline, Week 52
Change from Baseline in Patient Global Impression of Condition	Baseline, Week 52
Percent Change from Baseline in Total Cholesterol	Baseline, Week 52
Change from Baseline in Waist Circumference	Baseline, Week 52

Trial Locations

Locations (113)

University of Alabama -The Kirklin Clinic; 🇺🇸 Birmingham, Alabama, United States

AMR Clinical; 🇺🇸 Fort Myers, Florida, United States

Urologic Surgeons of Arizona; 🇺🇸 Mesa, Arizona, United States

Matrix Clinical Research; 🇺🇸 Los Angeles, California, United States

Alarcon Urology Center; 🇺🇸 Montebello, California, United States

Prestige Medical Group; 🇺🇸 Tustin, California, United States

Colorado Clinical Research; 🇺🇸 Lakewood, Colorado, United States

Altus Research; 🇺🇸 Lake Worth, Florida, United States

New Age Medical Research Corporation; 🇺🇸 Miami, Florida, United States

Emerald Coast OBGYN Clinical Research; 🇺🇸 Panama City, Florida, United States

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