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Trial · Interventional

Not yet recruitingPhase 4Registry data

Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)

Short name PROP-ZEP

Overview

Status
Not yet recruiting
Phase
Phase 4
Enrollment
20 participants (estimated)
Sponsor
University of North Carolina, Chapel Hill · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Sept 2026 (estimated)
Primary completion
Sept 2027 (estimated)
Completion
Sept 2027 (estimated)
First posted
10 Aug 2026
Last update posted
10 Aug 2026
Conditions
Pouch, Ileal · Pouches, Ileoanal · Bowel Diseases, Inflammatory

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 4

    PROP-ZEP

    NCT07756359

    est. Sept 2026 to est. Sept 2027

Registry summary

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.

Interventions

  • TirzepatideDrug
  • LoperamideDrug
  • Diphenoxylate/AtropineDrug

Arms2

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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)

    Registry description

    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

Secondary outcomes(9)
  1. 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)

    Registry description

    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.

  2. Change in Cleveland Clinic Global Quality of Life (QoL) scale

    Time frame · Week 1, Week 4, Week 8, Week 12 (Week 16 if applicable)

    Registry description

    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.

  3. 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)

    Registry description

    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.

  4. Number of Participants with AEs, SAEs and AEs Leading to Discontinuation of Study Intervention

    Time frame · Up to Week 12 (Week 16 if applicable)

    Registry description

    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

  5. Number of Participants with worsening laboratory values

    Time frame · Up to Week 12 (Week 16 if applicable)

    Registry description

    Number of participants with worsening fecal calprotectin laboratory values will be reported.

  6. Number of Participants with changes in nausea

    Time frame · Up to Week 12 (Week 16 if applicable)

    Registry description

    Number of participants with self described changes in nausea will be reported

  7. Number of Participants with changes in appetite

    Time frame · Up to Week 12 (Week 16 if applicable)

    Registry description

    Number of participants with self described changes in appetite will be reported

  8. Number of Participants with changes in abdominal pain

    Time frame · Up to Week 12 (Week 16 if applicable)

    Registry description

    Number of participants with self described changes in abdominal pain will be reported

  9. Number of Participants with changes in well-being

    Time frame · Up to Week 12 (Week 16 if applicable)

    Registry description

    Number of participants with self described changes in well being will be reported

Posted results

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

Studies8

Studies that cite this trial.

Studies with results

6 studies on this page

Indexing hint: Randomized controlled trial · 2025

7 results

Tirzepatide for Obesity Treatment and Diabetes Prevention.

Jastreboff et al. 2025The New England journal of medicinecited by 343

PMID 39536238DOI 10.1056/nejmoa2410819PUB-39536238

Full text at the publisher7 results

Indexing hint: Randomized controlled trial · 2024

1 result

Efficacy and Safety of Liraglutide in Patients With an Ileal Pouch-Anal Anastomosis and Chronic High Bowel Frequency: A Placebo-Controlled, Crossover, Proof-of-Concept Study.

Herfarth et al. 2024The American journal of gastroenterologycited by 3

PMID 38668926PMC11365596DOI 10.14309/ajg.0000000000002801PUB-38668926

Free to read · publisher termsCC BY-NC-ND1 result

Indexing hint: Randomized controlled trial · 2023

9 results

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.

Garvey et al. 2023Lancet (London, England)cited by 604

PMID 37385275DOI 10.1016/s0140-6736(23)01200-xPUB-37385275

Rights unknown9 results

Indexing hint: Randomized controlled trial · 2022

6 results

Tirzepatide Once Weekly for the Treatment of Obesity.

Jastreboff et al. 2022The New England journal of medicinecited by 2,802

PMID 35658024DOI 10.1056/nejmoa2206038PUB-35658024

Full text at the publisher6 results

Indexing hint: Randomized controlled trial · 2022

3 results

Safety and efficacy of liraglutide versus colesevelam for the treatment of bile acid diarrhoea: a randomised, double-blind, active-comparator, non-inferiority clinical trial.

Kårhus et al. 2022The lancet. Gastroenterology & hepatologycited by 46

PMID 35868334DOI 10.1016/s2468-1253(22)00198-4PUB-35868334

Full text at the publisher3 results

Indexing hint: Observational study · 2017

6 results

Effect of GLP-1 receptor agonist on gastrointestinal tract motility and residue rates as evaluated by capsule endoscopy.

Nakatani et al. 2017Diabetes & metabolismcited by 105

PMID 28648835DOI 10.1016/j.diabet.2017.05.009PUB-28648835

Full text at the publisher6 results

More studies

2 studies on this page

Indexing hint: Case report · 2019

Remission of Bile Acid Malabsorption Symptoms Following Treatment With the Glucagon-Like Peptide 1 Receptor Agonist Liraglutide.

Kårhus et al. 2019Gastroenterologycited by 22

PMID 30965026DOI 10.1053/j.gastro.2019.04.002PUB-30965026

Full text at the publisher
Publisher page

PubMed tag: none · 2018

Effect of Liraglutide Treatment on Jejunostomy Output in Patients With Short Bowel Syndrome: An Open-Label Pilot Study.

Hvistendahl et al. 2018JPEN. Journal of parenteral and enteral nutritioncited by 50

PMID 27875281DOI 10.1177/0148607116672265PUB-27875281

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Informed consent will be obtained before any study-related procedures * Age \> 18 and \<80 years * Patients with an IPAA and bowel frequency \> 8 bowel movements in 24 hours on at least 4 of 7 days/week (and/or an average of \>8 bowel movements in the 7 days preceding enrollment) * Patients must have demonstrated high bowel frequency despite adequate therapy for high bowel frequency with loperamide 2 mg orally every 6 hours as needed (at least 3 doses daily) and/or diphenoxylate/atropine 2 mg orally every 6 hours as needed (at least 3 doses daily) or proven intolerance to these anti-diarrheal medications. * Among patients with inflammatory conditions of the pouch, high bowel frequency must be demonstrated despite adequate therapy for intermittent pouchitis, chronic pouchitis, or Crohn's like disease of the pouch. Adequate therapy is required to ensure significant pouch inflammation is not a driver of high bowel frequency (described in Exclusion Criteria). * Participants with a proven history of ulcerative colitis and history of 1,2, modified -2 or 3 stage IPAA and ileostomy takedown * Ability to access internet for electronic database entry Exclusion Criteria: * Prior exposure to tirzepatide or other GLP-1RA * BMI \<20 at the time of study screening * Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 * Known hypersensitivity to tirzepatide or its metabolites * Significant pouch inflammation defined as an endoscopic pouch disease activity index (PDAI ) ≥ 4 * Known stricture of the ileo-anal anastomosis or afferent limb stricture * New onset of high bowel frequency in the setting of acute pouchitis * Final stage of IPAA surgery \< 6 months prior to enrollment * Current infection with Clostridioides difficile * Known HIV or active Hepatitis B/C * Clinically significant liver disease (Primary Sclerosing Cholangitis with LFT's \<1.5 upper limit of normal can be included) * Severe hepatic impairment, defined as Child-Pugh Class C * Known clinically significant chronic nausea and/or vomiting in the past * Known diagnosis of type 1 or type 2 diabetes * Known decreased kidney function with a glomerular filtration rate \<30 ml/min/1.732 * History of malignancy, except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin, or prior malignancy with curative therapy completed at least 5 years prior to screening and no recurrence. * New York Heart Association class 3 or greater heart failure or recent (within 6 months) cardiovascular event * Prior history of pancreatitis * Clinically significant laboratory results at screening or baseline, as judged by the Investigator from local testing. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. * Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. * Any disorder, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.

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