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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Orforglipron (GZS1) 		Participants will receive orforglipron orally
  • Drug: Orforglipron
    Administered orally
    Other names:
    • LY3502970
Placebo Comparator
Placebo (GZS1) 		Participants will receive placebo orally
  • Drug: Placebo
    Administered orally
Experimental
Orforglipron (GZS2) 		Participants will receive orforglipron orally
  • Drug: Orforglipron
    Administered orally
    Other names:
    • LY3502970
Placebo Comparator
Placebo (GZS2) 		Participants will receive placebo orally
  • Drug: Placebo
    Administered orally

Recruiting Locations

University of Alabama -The Kirklin Clinic
Birmingham, Alabama 35233

AMR Clinical
Mobile, Alabama 36608

Urologic Surgeons of Arizona
Mesa, Arizona 85206

Matrix Clinical Research
Los Angeles, California 90057
Contact:
310-424-5922

Alarcon Urology Center
Montebello, California 90640

Prestige Medical Group
Tustin, California 92780

Colorado Clinical Research
Lakewood, Colorado 80228
Contact:
303-996-9649

AMR Clinical
Fort Myers, Florida 33912
Contact:
239-936-4421

Altus Research
Lake Worth, Florida 33461
Contact:
561-641-0404

New Age Medical Research Corporation
Miami, Florida 33186
Contact:
305-596-9901

Emerald Coast OBGYN Clinical Research
Panama City, Florida 32405

Teak Research Consults
Lawrenceville, Georgia 30043

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan 48098
Contact:
248-312-0025

OB/GYN Associates of Erie
Erie, Pennsylvania 16507

Clinical Research of Philadelphia
Philadelphia, Pennsylvania 19114
Contact:
215-676-6696

Next Level Urgent Care
Houston, Texas 77057
Contact:
832-460-3311

Innovative Medical Research of Texas
Houston, Texas 77065

Health Research of Hampton Roads, Inc.
Newport News, Virginia 23606
Contact:
757-591-8100

Urology of Virginia
Virginia Beach, Virginia 23462

Northwest Clinical Research Center
Bellevue, Washington 98007
Contact:
877-453-0404

Seattle Clinical Research Center
Seattle, Washington 98104
Contact:
206-522-3330

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.