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

NCT07202884 · tracked via the Priya Life Science USA tracker

Sponsor

Eli Lilly and Company

Phase

Phase 3

Started

2025-09-30

Last updated

2026-09-08

Condition(s) studied

Urinary Incontinence,Stress

Investigational drug(s) / intervention(s)

OrforglipronPlacebo

Orforglipron: Administered orally

Placebo: Administered orally

Study 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (136)

Facility	City	Region	Status
University of Alabama -The Kirklin Clinic	Birmingham	Alabama	Recruiting
AMR Clinical	Mobile	Alabama	Recruiting
Urologic Surgeons of Arizona	Mesa	Arizona	Not Yet Recruiting
Matrix Clinical Research	Los Angeles	California	Recruiting
Alarcon Urology Center	Montebello	California	Recruiting
Prestige Medical Group	Tustin	California	Completed
Colorado Clinical Research	Lakewood	Colorado	Recruiting
AMR Clinical	Fort Myers	Florida	Recruiting
Altus Research	Lake Worth	Florida	Recruiting
New Age Medical Research Corporation	Miami	Florida	Recruiting
Emerald Coast OBGYN Clinical Research	Panama City	Florida	Recruiting
Teak Research Consults	Lawrenceville	Georgia	Recruiting
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan	Recruiting
OB/GYN Associates of Erie	Erie	Pennsylvania	Recruiting
Clinical Research of Philadelphia	Philadelphia	Pennsylvania	Recruiting
Next Level Urgent Care	Houston	Texas	Recruiting
Innovative Medical Research of Texas	Houston	Texas	Recruiting
Health Research of Hampton Roads, Inc.	Newport News	Virginia	Recruiting
Urology of Virginia	Virginia Beach	Virginia	Recruiting
Northwest Clinical Research Center	Bellevue	Washington	Recruiting
Seattle Clinical Research Center	Seattle	Washington	Recruiting
OCT Research ULC	Kelowna	Canada	Recruiting
Kelowna Health and Memory Centre	Kelowna	Canada	Recruiting
Alpha Recherche Clinique - Lévis	Lévis	Canada	Recruiting
The Fe/Male Health Centre	Oakville	Canada	Recruiting
Alpha Recherche Clinique	Québec	Canada	Recruiting
ALPHA Recherche Clinique	Québec	Canada	Recruiting
CaRe Clinic	Red Deer	Canada	Recruiting
Sunnybrook Research Institute	Toronto	Canada	Recruiting
Peking University People's Hospital	Beijing	China	Recruiting
Xuanwu Hospital Capital Medical University	Beijing	China	Recruiting
Peking University Third Hospital	Beijing	China	Recruiting
Peking University First Hospital	Beijing	China	Recruiting
Sichuan Provincial People's Hospital	Chengdu	China	Not Yet Recruiting
Chengdu Women and Children Center Hospital	Chengdu	China	Recruiting
2nd Affiliated Hospital Chongqing Medical University	Chongqing	China	Recruiting
Zhujiang Hospital	Guangzhou	China	Recruiting
The First Affiliated Hospital of Jinan University	Guangzhou	China	Recruiting
Zhejiang Provincial People's Hospital	Hangzhou	China	Recruiting
Second Affiliated hospital of Anhui Medical University	Hefei	China	Recruiting

+ 96 more sites — see the full list on the official registry below.

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Other trials for the same condition

Adjustable Continence Therapy (ACT) for the Treatment of Female SUI Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07202884 on ClinicalTrials.gov ↗ ← All trials in the USA