A Phase 3 interventional study of Orforglipron and Placebo in Urinary Incontinence,Stress, sponsored by Eli Lilly and Company. Recruiting at 120 sites in 9 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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.
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 68 across 506 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive orforglipron orally
Drug: Orforglipron
Participants will receive placebo orally
Drug: Placebo
Participants will receive orforglipron orally
Drug: Orforglipron
Participants will receive placebo orally
Drug: Placebo
Administered orally
Also known as: LY3502970
Administered orally
Change from Baseline in Incontinence Episode Frequency (IEF)
Time frame: Baseline, Week 52
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
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Showing the first 100 of 120 sites across 9 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Orforglipron
Urinary Incontinence, Stress →