Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Prior exposure to tirzepatide or other GLP-1RA
BMI <20 at the time of study screening
Trial design
Design model
Parallel
Treatments tested in this trial
Tirzepatide
DrugTirzepatide will be administered subcutaneously
Loperamide
Drug2 mg orally every 6 hours as needed
Diphenoxylate/Atropine
Drug2 mg orally every 6 hours
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: TirzepatideExperimental treatment 1 intervention
Group B: Optimized Standard of Care anti-diarrheal therapyActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Proportion of patients achieving a decrease of the average daily bowel frequency by 30% at 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
Time frame
Week 12 (Week 16 if applicable)Secondary outcomes
1
The proportion of patients achieving an average bowel frequency of ≤8 bowel movements daily.
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.
Time frame
Week 1, Week 4, Week 8, Week 12, Week 16 (if applicable)2
Change in Cleveland Clinic Global Quality of Life (QoL) scale
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.
Time frame
Week 1, Week 4, Week 8, Week 12 (Week 16 if applicable)3
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) incontinence measure
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.
Time frame
Week 1, Week 4, Week 8, Week 12 (Week 16 if applicable)4
Number of Participants with AEs, SAEs and AEs Leading to Discontinuation of Study Intervention
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
Time frame
Up to Week 12 (Week 16 if applicable)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov
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