LivingGLP1
Study S001709

Efficacy of the Dual GIP - GLP-1 Receptor Agonist Tirzepatide in Patients With an Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)

ClinicalTrials.gov record

Registration

Registration
NCT07756359
Acronym
PROP-ZEP
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE4
Masking
NONE
Status
NOT_YET_RECRUITING
Enrollment
20
Start
2026-09
Primary completion
2027-09
Lead sponsor
University of North Carolina, Chapel Hill
Conditions
Pouch, Ileal; Pouches, Ileoanal; Bowel Diseases, Inflammatory
Interventions
DRUG:Tirzepatide; DRUG:Loperamide; DRUG:Diphenoxylate/Atropine
Results posted
FALSE
Individual participant data sharing
YES

Registered primary outcomes

  • Proportion of patients achieving a decrease of the average daily bowel frequency by 30% at week 12 (Week 16 if applicable) [Week 12 (Week 16 if applicable)]

Linked records (11)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0017665Tirzepatide for Obesity Treatment and Diabetes Prevention.
Jastreboff AM, The New England journal of medicine
2025Randomized trialPMID 39536238DOIregistry reference BACKGROUND:39536238
R0009933Efficacy 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 H, The American journal of gastroenterology
2024Randomized trialPMID 38668926DOIregistry reference BACKGROUND:38668926
R0008662Tirzepatide 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 WT, Lancet (London, England)
2023Randomized trialPMID 37385275DOIregistry reference BACKGROUND:37385275
R0010502Safety and efficacy of liraglutide versus colesevelam for the treatment of bile acid diarrhoea: a randomised, double-blind, active-comparator, non-inferiority clinical trial.
Kårhus ML, The lancet. Gastroenterology & hepatology
2022Randomized trialPMID 35868334DOIregistry reference BACKGROUND:35868334
R0010987Tirzepatide Once Weekly for the Treatment of Obesity.
Jastreboff AM, The New England journal of medicine
2022Randomized trialPMID 35658024DOIregistry reference BACKGROUND:35658024
R0008255Remission of Bile Acid Malabsorption Symptoms Following Treatment With the Glucagon-Like Peptide 1 Receptor Agonist Liraglutide.
Kårhus ML, Gastroenterology
2019Case reportPMID 30965026DOIregistry reference BACKGROUND:30965026
R0014618Effect of Liraglutide Treatment on Jejunostomy Output in Patients With Short Bowel Syndrome: An Open-Label Pilot Study.
Hvistendahl M, JPEN. Journal of parenteral and enteral nutrition
2018Randomized trialPMID 27875281DOIregistry reference BACKGROUND:27875281
R0013369Effect of GLP-1 receptor agonist on gastrointestinal tract motility and residue rates as evaluated by capsule endoscopy.
Nakatani Y, Diabetes & metabolism
2017Nonrandomized studyPMID 28648835DOIregistry reference BACKGROUND:28648835
R0012058The Glucagon-Like Peptide 1 Receptor Agonist Exenatide Inhibits Small Intestinal Motility, Flow, Transit, and Absorption of Glucose in Healthy Subjects and Patients With Type 2 Diabetes: A Randomized Controlled Trial.
Thazhath SS, Diabetes
2016Randomized trialPMID 26470783DOIregistry reference BACKGROUND:26470783
R0056885Gut hormones in the treatment of short-bowel syndrome and intestinal failure.
Jeppesen PB, Current opinion in endocrinology, diabetes, and obesity
2015Other trialPMID 25485516DOIregistry reference BACKGROUND:25485516
R0024859Efficacy of the glucagon-like peptide-1 agonist exenatide in the treatment of short bowel syndrome.
Kunkel D, Neurogastroenterology and motility
2011OtherPMID 21557790DOIregistry reference BACKGROUND:21557790