A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight (RESTRAIN-SUI)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Urinary Incontinence,Stress

Treatments: Drug: Placebo; Drug: Orforglipron

Study type: Interventional

Funder types: Industry

Identifiers

NCT07202884

J2A-MC-GZS2 (Other Identifier)

27672

J2A-MC-GZPS (Other Identifier)

J2A-MC-GZS1 (Other Identifier)

2025-522514-23-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 4 patient groups, including a placebo group

Orforglipron (GZS1)

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Placebo (GZS1)

Placebo Comparator group

Description:

Participants will receive placebo orally

Treatment:

Drug: Placebo

Orforglipron (GZS2)

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Placebo (GZS2)

Placebo Comparator group

Description:

Participants will receive placebo orally

Treatment:

Drug: Placebo