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

Short name RESTRAIN-SUI

NCTNCT07202884Other id27672Other id2025-522514-23-00Other idJ2A-MC-GZPSOther idJ2A-MC-GZS1

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 3
Enrollment: 1,000 participants (estimated)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Double masking
Countries: 10 countries
United States, Canada, China, Czechia, India, Japan, Mexico, Poland, Romania, South Korea
Start: 30 Sept 2025
Primary completion: Mar 2028 (estimated)
Completion: Mar 2028 (estimated)
First posted: 2 Oct 2025
Last update posted: 8 Oct 2026
Conditions: Urinary Incontinence,Stress

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20252026202720282029

Ph 3
RESTRAIN-SUI
NCT07202884
30 Sept 2025 to est. Mar 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

OrforglipronDrug
PlaceboDrug

Arms4

Experimental
Orforglipron (GZS1)
Participants will receive orforglipron orally
Placebo comparator
Placebo (GZS1)
Participants will receive placebo orally
Experimental
Orforglipron (GZS2)
Participants will receive orforglipron orally
Placebo comparator
Placebo (GZS2)
Participants will receive placebo orally

Primary outcomes1

Outcomes the sponsor listed as primary.

Change from Baseline in Incontinence Episode Frequency (IEF)
Time frame · Baseline, Week 52

Secondary outcomes(6)

Percent Change from Baseline in Body Weight
Time frame · Baseline, Week 52
Change from Baseline in Urinary Incontinence-Specific Quality of Life
Time frame · Baseline, Week 52
Change from Baseline in Number of Continence Pad (CAPD) Used Per Week
Time frame · Baseline, Week 52
Change from Baseline in Patient Global Impression of Condition
Time frame · Baseline, Week 52
Percent Change from Baseline in Total Cholesterol
Time frame · Baseline, Week 52
Change from Baseline in Waist Circumference
Time frame · Baseline, Week 52

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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