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

ConditionUrinary Incontinence,Stress
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Orforglipron

    Drug

    Administered orally

  • Placebo

    Drug

    Administered orally

Treatment groups

1,000 Participants
are divided into 4 treatment groups
Group A: Orforglipron (GZS1)Experimental treatment 1 intervention
Group B: Placebo (GZS1)Placebo comparator 1 intervention
Group C: Orforglipron (GZS2)Experimental treatment 1 intervention
Group D: Placebo (GZS2)Placebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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