Indexing hint: Randomized controlled trial · 2025
Tirzepatide for Obesity Treatment and Diabetes Prevention.
Jastreboff et al. 2025The New England journal of medicinecited by 343
PMID 39536238DOI 10.1056/nejmoa2410819PUB-39536238
Trial · Interventional
Not yet recruitingPhase 4Registry dataShort name PROP-ZEP
United States
1 trial · 1 not yet recruiting
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The goal of this clinical trial is to learn if Tirzepatide (Zepbound) can decrease bowel frequency in patients that have an ileal-pouch anal anastomosis (IPAA or pouch) better than standard of care anti-diarrheal therapy. The main question it aims to answer is: Does Tirzepatide reduce bowel frequency better than standard of care anti-diarrheal therapy in patients that have a pouch Participants will: Visit the clinic 5 times, answer questions about symptoms daily, be assigned to take the study product as instructed and provide a stool sample 4 times.
Experimental
Tirzepatide
Treatment will start at 2.5 mg once weekly. After 4 weeks, the dose will be increased to 5 mg once weekly. After another 4 weeks, the dose will be increased to 7.5 mg once weekly for 4 weeks.
Active comparator
Optimized Standard of Care anti-diarrheal therapy
Optimized regimen of loperamide 2 mg orally every 6 hours as needed for increased frequency or diphenoxylate/atropine can be given 2 mg orally every 6 hours. When using either or both therapies in combination the participant should not exceed a maximum dose of 16 mg orally within 24 hours. For participants with continued or worsening high bowel frequency for \>2 weeks, transition to active therapy with tirzepatide will be offered at week 4. Tirzepatide treatment would begin as 2.5 mg once weekly. After 4 weeks, the dose will be increased to 5 mg once weekly. After another 4 weeks, the dose will be increased to 7.5 mg once weekly for 4 weeks.
Outcomes the sponsor listed as primary.
Proportion of patients achieving a decrease of the average daily bowel frequency by 30% at week 12 (Week 16 if applicable)
Time frame · Week 12 (Week 16 if applicable)
Daily bowel frequency will be calculated by the median 24 hour bowel frequency over the 7 days prior to the week 12 assessment; to be eligible for this calculation, participants will need to complete stool diaries on at least 4 of the 7 days. Note: A 30% reduction will equate to 3-4 bowel movements in a 24-hour time period for the anticipated eligible population
The proportion of patients achieving an average bowel frequency of ≤8 bowel movements daily.
Time frame · Week 1, Week 4, Week 8, Week 12, Week 16 (if applicable)
Daily bowel frequency will be calculated by the median 24 hour bowel frequency over the 7 days prior to the assessment; to be eligible for this calculation, participants will need to complete stool diaries on at least 4 of the 7 days.
Change in Cleveland Clinic Global Quality of Life (QoL) scale
Time frame · Week 1, Week 4, Week 8, Week 12 (Week 16 if applicable)
The Cleveland Clinic Global Quality of Life scale asks the patient to rate their current QoL, current quality of health, and current energy level using a 1-10 rating (where 10 is best). The score on each of these 3 components is added and the final Cleveland Clinic Global Quality of Life utility score can be obtained by dividing this result by 30. A higher score means improved quality of life.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) incontinence measure
Time frame · Week 1, Week 4, Week 8, Week 12 (Week 16 if applicable)
The PROMIS measure for incontinence includes 4 items that assess the frequency of bowel incontinence, soiling, stool leakage, and stool leakage while passing gas over the past 7 days. Score range is 0-20, where a higher score means increased incontinence.
Number of Participants with AEs, SAEs and AEs Leading to Discontinuation of Study Intervention
Time frame · Up to Week 12 (Week 16 if applicable)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, results in another serious or important medical event
Number of Participants with worsening laboratory values
Time frame · Up to Week 12 (Week 16 if applicable)
Number of participants with worsening fecal calprotectin laboratory values will be reported.
Number of Participants with changes in nausea
Time frame · Up to Week 12 (Week 16 if applicable)
Number of participants with self described changes in nausea will be reported
Number of Participants with changes in appetite
Time frame · Up to Week 12 (Week 16 if applicable)
Number of participants with self described changes in appetite will be reported
Number of Participants with changes in abdominal pain
Time frame · Up to Week 12 (Week 16 if applicable)
Number of participants with self described changes in abdominal pain will be reported
Number of Participants with changes in well-being
Time frame · Up to Week 12 (Week 16 if applicable)
Number of participants with self described changes in well being will be reported
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
Studies that cite this trial.
6 studies on this page
Indexing hint: Randomized controlled trial · 2025
Jastreboff et al. 2025The New England journal of medicinecited by 343
PMID 39536238DOI 10.1056/nejmoa2410819PUB-39536238
Indexing hint: Randomized controlled trial · 2024
Herfarth et al. 2024The American journal of gastroenterologycited by 3
PMID 38668926PMC11365596DOI 10.14309/ajg.0000000000002801PUB-38668926
Indexing hint: Randomized controlled trial · 2023
Garvey et al. 2023Lancet (London, England)cited by 604
PMID 37385275DOI 10.1016/s0140-6736(23)01200-xPUB-37385275
Indexing hint: Randomized controlled trial · 2022
Jastreboff et al. 2022The New England journal of medicinecited by 2,802
PMID 35658024DOI 10.1056/nejmoa2206038PUB-35658024
Indexing hint: Randomized controlled trial · 2022
Kårhus et al. 2022The lancet. Gastroenterology & hepatologycited by 46
PMID 35868334DOI 10.1016/s2468-1253(22)00198-4PUB-35868334
Indexing hint: Observational study · 2017
Nakatani et al. 2017Diabetes & metabolismcited by 105
PMID 28648835DOI 10.1016/j.diabet.2017.05.009PUB-28648835
2 studies on this page
Indexing hint: Case report · 2019
Kårhus et al. 2019Gastroenterologycited by 22
PMID 30965026DOI 10.1053/j.gastro.2019.04.002PUB-30965026
PubMed tag: none · 2018
Hvistendahl et al. 2018JPEN. Journal of parenteral and enteral nutritioncited by 50
PMID 27875281DOI 10.1177/0148607116672265PUB-27875281
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