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

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

  • Urinary Incontinence,Stress

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

AMR Clinical
Mobile 4076598, Alabama 4829764 36608

Urologic Surgeons of Arizona
Mesa 5304391, Arizona 5551752 85206

Matrix Clinical Research
Los Angeles 5368361, California 5332921 90057
Contact:
310-424-5922

Alarcon Urology Center
Montebello 5374322, California 5332921 90640

Prestige Medical Group
Tustin 5404119, California 5332921 92780

AMR Clinical
Fort Myers 4155995, Florida 4155751 33912
Contact:
239-936-4421

Altus Research
Lake Worth 4161422, Florida 4155751 33461
Contact:
561-641-0404

New Age Medical Research Corporation
Miami 4164138, Florida 4155751 33186
Contact:
305-596-9901

Teak Research Consults
Lawrenceville 4205196, Georgia 4197000 30043

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy 5012639, Michigan 5001836 48098
Contact:
248-312-0025

OB/GYN Associates of Erie
Erie 5188843, Pennsylvania 6254927 16507

Clinical Research of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19114
Contact:
215-676-6696

Next Level Urgent Care
Houston 4699066, Texas 4736286 77057
Contact:
832-460-3311

Innovative Medical Research of Texas
Houston 4699066, Texas 4736286 77065

Health Research of Hampton Roads, Inc.
Newport News 4776024, Virginia 6254928 23606
Contact:
757-591-8100

Northwest Clinical Research Center
Bellevue 5786882, Washington 5815135 98007
Contact:
877-453-0404

Seattle Clinical Research Center
Seattle 5809844, Washington 5815135 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