A Phase 3 interventional study of Berobenatide and Placebo in Urinary Incontinence, Stress and Overweight and/or Obesity, sponsored by Pfizer. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
The purpose of this study is to learn about the safety and effectiveness of berobenatide in adult women who have both stress urinary incontinence (SUI) and obesity or overweight.
Participants will be in the study for about 63 weeks
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's planned enrollment of 900 is above the median of 68 across 506 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) 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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Berobenatide administered according to the study dosing regimen
Drug: Berobenatide
Participants will receive placebo administered according to the study dosing regimen
Drug: Placebo
Berobenatide administered by subcutaneous injection
Also known as: MET-097i, PF-08653944
Placebo administered by subcutaneous injection
Change From Baseline in Stress Incontinence Episode Frequency (IEF)
Time frame: Baseline, Week 52
Percent Change From Baseline in Body Weight
Time frame: Baseline, Week 52
Percent change from baseline in Stress Incontinence Episode Frequency
Time frame: Baseline, Week 52
Change from Baseline in Urinary Incontinence-Specific Quality of Life as assessed by the Quality-of-Life Instrument (QOL)
Time frame: Baseline, Week 52
Change from Baseline in Fasting Lipids
Time frame: Baseline, Week 52
Change From Baseline in weight
Time frame: Baseline, Week 52
Change From Baseline in waist circumference
Time frame: Baseline, Week 52
Number of participants with Treatment-Emergent Adverse Event (TEAE)
Time frame: Week 52
No study locations are listed for this record.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Data sharing details ↗ · www.pfizer.com
Start is estimated for Nov 2026; primary completion for Oct 2028, 22 months later.
Of 14 phase 3 interventional studies under Urinary Incontinence, Stress, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 51. This study's planned 22 months is below that.
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Urinary Incontinence, Stress →