DelfaGLP-1 Atlas

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RESTRAIN-SUI

RecruitingPhase 3

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

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

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

137

Recruiting sites

112

Enrollment

1,000

estimated

Study population

Obesity / overweight, Urinary Incontinence, Stress

Key I/E criterion

•Female

Primary endpoint

•Incontinence Episode Frequency (IEF)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07202884
Org study ID27672
Secondary ID2025-522514-23-00
Secondary IDJ2A-MC-GZPSEli Lilly and Company
Secondary IDJ2A-MC-GZS1Eli Lilly and Company
Secondary IDJ2A-MC-GZS2Eli Lilly and Company

Timeline

Milestones

Study start2025-09-30actual
Study first posted2025-10-02actual
Last update posted2026-05-22actual
Primary completion2028-03estimated (month precision)
Study completion2028-03estimated (month precision)

Assets

Investigational agents

Orforglipron

Study populations

Who this study enrolls

Obesity / overweightUrinary Incontinence, Stress

Eligibility

Who can enroll

Minimum age18 Years
SexFemale
Healthy volunteersNot accepted

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

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
2
Patient-reported / QoL
2
Other clinical outcomes
2
Cardiometabolic biomarkers
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 52

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 52

Waist circumference, change

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Percent Change from Baseline in Total Cholesterol

Time frame:Baseline, Week 52

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Change from Baseline in Urinary Incontinence-Specific Quality of Life

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Patient Global Impression of Condition

Time frame:Baseline, Week 52

PGI, change

change from baseline, improvement

Other clinical outcomes

2 endpoints
Primary/protocol endpoint

Change from Baseline in Incontinence Episode Frequency (IEF)

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 52

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.