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NCT Number: NCT07202884

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

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.

Recruiting

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Key information

Conditions

Urinary Incontinence,Stress Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Kelowna Health and Memory Centre, Kelowna, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orforglipron

Drug

Administered orally

Other names: LY3502970

Placebo

Drug

Administered orally

Primary outcomes

  1. Change from Baseline in Incontinence Episode Frequency (IEF)

    Time frame: Baseline, Week 52

Secondary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 52

  2. Change from Baseline in Urinary Incontinence-Specific Quality of Life

    Time frame: Baseline, Week 52

  3. Change from Baseline in Number of Continence Pad (CAPD) Used Per Week

    Time frame: Baseline, Week 52

  4. Change from Baseline in Patient Global Impression of Condition

    Time frame: Baseline, Week 52

  5. Percent Change from Baseline in Total Cholesterol

    Time frame: Baseline, Week 52

  6. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Acronym: RESTRAIN-SUI

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 2, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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