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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Efficacy of Liraglutide Therapy in Patients With IPAA

NCTNCT04763564 (opens ClinicalTrials.gov in a new tab)Other id20-3016Other idU1111-1252-6589
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2
Enrollment
8 participants (actual)
Sponsor
University of North Carolina, Chapel Hill · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
22 Mar 2022
Primary completion
16 Oct 2023
Completion
16 Oct 2023
First posted
21 Feb 2021
Last update posted
23 Jul 2024
Conditions
Pouchitis · Irritable Pouch Syndrome

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202220232024
  1. Ph 2

    Efficacy of Liraglutide Therapy in Patients With IPAA

    NCT04763564

    22 Mar 2022 to 16 Oct 2023

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Patients with an ileal pouch-anal anastomosis(IPAA; pouch) due to refractory inflammatory bowel disease and increased bowel frequency in the absence of significant pouch inflammation will be randomized to liraglutide or placebo in a prospective cross over study.

Interventions

  • Liraglutide Pen InjectorDrug
  • Placebo Pen InjectorDrug

Arms2

  • Experimental

    Liraglutide then Placebo

    Participants will be randomly assigned to 6-week Liraglutide treatment. Then after a 5-day washout, treatment will continue with 6 weeks of placebo.

  • Experimental

    Placebo then Liraglutide

    Participants will be randomly assigned to 6-week placebo treatment. Then after a 5-day washout, treatment will continue with 6 weeks of Liraglutide.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Mean % Reduction of Bowel Frequency in Percent of the Mean 7-day Bowel Frequency After 4 Weeks of Therapy on Liraglutide vs Placebo Compared to Baseline .

    Time frame · Baseline, Week 4 (treatment period 1) and week 10 (treatment period 2)

    Registry description

    Mean percentage reduction of 7-day bowel frequency after 4 weeks of therapy on Liraglutide vs placebo compared to baseline (baseline is defined as the mean 7-day bowel frequency in a 7-day period during the screening period before week 0). Due to the cross-over design, the outcome is reported depending on randomization in treatment period 1 at week 4 and treatment period 2 at week 10 vs baseline.

Secondary outcomes(3)

  1. Change in the 7 Day Mean Number of Day and Night Bowel Frequency at Week 4 and 6 vs Baseline on Liraglutide vs Placebo

    Time frame · Baseline, Week 4 and week 6 (treatment period 1) and week 10 and week 12 (treatment period 2)

    Registry description

    Bowel frequency during the day and night was recorded on a daily basis. The 7-day mean number of bowel movements during the day (from getting up until bedtime) and during the night (during sleep) at baseline and at weeks 4 and 6 on liraglutide or placebo therapy is depicted. Baseline, week 4 and week 6 (treatment period 1) and week 10 and week 12 (treatment period 2)

  2. Discontinuation of Therapy in Each Treatment Arm

    Time frame · treatment period 1 before week 6 or treatment period 2 before week 12

    Registry description

    Number of patients discontinuing Liraglutide therapy in treatment or placebo arm due to intolerance in treatment period 1 before week 6 or treatment period 2 before week 12

  3. Mean % Reduction of Bowel Frequency in Percent of the Mean 7-day Bowel Frequency After 6 Weeks of Therapy on Liraglutide vs Placebo Compared to Baseline.

    Time frame · Baseline, week 6 (treatment period 1) and week 12 (treatment period 2)

    Registry description

    Mean percentage reduction of 7-day bowel frequency after 6 weeks of therapy on Liraglutide vs placebo compared to baseline (baseline is defined as the mean 7-day bowel frequency in a 7-day period during the screening period before week 0). Due to the cross-over design, the outcome is reported depending on randomization in treatment period 1 at week 6 or treatment period 2 at week 12 vs baseline.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline, Week 4 (treatment period 1) and week 10 (treatment period 2)

Mean % Reduction of Bowel Frequency in Percent of the Mean 7-day Bowel Frequency After 4 Weeks of Therapy on Liraglutide vs Placebo Compared to Baseline .

GroupValue (percentage reduction of bowel frequency)Spread
Liraglutide36.319.8
Placebo17.315.7
Secondary and other outcome results(3)
Secondary outcomeMean· Baseline, Week 4 and week 6 (treatment period 1) and week 10 and week 12 (treatment period 2)

Change in the 7 Day Mean Number of Day and Night Bowel Frequency at Week 4 and 6 vs Baseline on Liraglutide vs Placebo

GroupValue (Bowel movements / day or night)Spread
Liraglutide8.82.3
Placebo8.82.3
Secondary outcomeCount of participants· treatment period 1 before week 6 or treatment period 2 before week 12

Discontinuation of Therapy in Each Treatment Arm

GroupValue (Participants)
Liraglutide0
Placebo0
Secondary outcomeMean· Baseline, week 6 (treatment period 1) and week 12 (treatment period 2)

Mean % Reduction of Bowel Frequency in Percent of the Mean 7-day Bowel Frequency After 6 Weeks of Therapy on Liraglutide vs Placebo Compared to Baseline.

GroupValue (Percent reduction of bowel frequency)Spread
Liraglutide36.818.7
Placebo15.75.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Liraglutide6-week Liraglutide treatment. Liraglutide Pen Injector: Treatment will be initiated at 0.6 mg per day for one week. The patient will be instructed to increase the dose to 1.2/day and 1.8 mg /day in week 2 and in week 3, respectively. From week 3 after the start of the drug until week 6 the patient will apply 1.8 mg/day liraglutide. In case of intolerance (e.g. occurrence of refractory nausea) at a higher dose (e.g. 1.8 mg daily, the highest dose in this trial) liraglutide can be reduced to the previous level.0 / 80 / 88 / 8
Placebo6-week placebo treatment. Placebo Pen Injector: Matching placebo pens used to administer normal saline in the same fashion as for liraglutide0 / 80 / 86 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

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
Read at sourceSee results (1)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Informed consent will be obtained before any trial-related procedures * Age \> 18 years * Patients with IPAA and bowel frequency \> 8 bowel movements in 24 hours on at least 4 of 7 days/week and presence of high bowel frequency \> 4 weeks despite adequate therapy for acute pouchitis or Crohn's like disease of the pouch Exclusion Criteria: * 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 * IPAA since \< 6 months * Known Clostridium difficile pouchitis * Known clinically significant chronic nausea and/or vomiting in the past * Known type 1 or type 2 diabetes * History of or active neoplasia * Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 * Renal impairment defined as glomerular filtration rate (glomerular filtration rate \< 30) * Clinically significant decompensated liver disease defined as elevation of aspartate aminotransferase , alanine transaminase or bilirubin \> 2-fold the upper limits of normal (Primary Sclerosing Cholangitis with liver function tests (LFT's) \<1.5 upper limits of normal can be included) * New York Heart Association class 3 or greater heart failure or recent (within 6 months) cardiovascular event * Prior history of pancreatitis * Prior treatment with a GLP-1receptor agonist * Known hypersensitivity to liraglutide or any product components * 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 patient's safety or compliance with the protocol.

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