GLP-1 Peptide Atlas, by Delfa

TerminatedPhase 2Results posted

Efficacy of Liraglutide Therapy in Patients With IPAA

Efficacy of Liraglutide Therapy in Patients With an Ileal -Pouch Anal Anastomosis (IPAA) and Chronic High Bowel Frequency

Lead sponsor

University of North Carolina, Chapel Hill

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Gastrointestinal (gastroparesis / short bowel / pancreatitis)

Key I/E criterion

—

Primary endpoint

•Mean % Reduction of Bowel Frequency in Percent of the Mean 7-day Bowel

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04763564

Org study ID20-3016

Secondary IDU1111-1252-6589WHO Universal Trial Number

Timeline

Milestones

Study first posted2021-02-21actual

Study start2022-03-22actual

Primary completion2023-10-16actual

Study completion2023-10-16actual

Last update posted2024-07-23actual

Results first posted2024-07-23actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Gastrointestinal (gastroparesis / short bowel / pancreatitis)

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Discontinuation of Therapy in Each Treatment Arm

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

Discontinuation due to AE

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide	0	—
Placebo	0	—

Secondary/protocol endpoint

Discontinuation of Therapy in Each Treatment Arm

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

Discontinuation due to AE

event count, event

Other clinical outcomes

6 endpoints

Primary/registry result

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)

percent change from baseline, improvement

Posted result

Group	Value (mean), percentage reduction of bowel frequency	95% CI
Liraglutide	36.3	—
Placebo	17.3	—

p<0.03Mixed Models Analysis

Primary/protocol endpoint

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)

percent change from baseline, improvement

Secondary/registry result

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)

change from baseline, improvement

Posted result

Group	Value (mean), Bowel movements / day or night	95% CI
LiraglutideBaseline Bowel Frequency Day	8.8	—
Baseline Bowel Frequency Night	3.3	—
Week 4 Day	5.3	—
Week 4 Night	2.3	—
Week 6 Day	5.4	—
Week 6 Night Placebo week 6	2.1	—
PlaceboBaseline Bowel Frequency Day	8.8	—
Baseline Bowel Frequency Night	8.8	—
Week 4 Day	6.9	—
Week 4 Night	3.1	—
Week 6 Day	7.0	—
Week 6 Night Placebo week 6	3.1	—

Secondary/registry result

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)

percent change from baseline, improvement

Posted result

Group	Value (mean), Percent reduction of bowel frequency	95% CI
Liraglutide	36.8	—
Placebo	15.7	—

p0.01Mixed Models Analysis

Secondary/protocol endpoint

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)

change from baseline, improvement

Secondary/protocol endpoint

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)

percent change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
The American journal of gastroenterology2024 Sep 1PMID38668926doi:10.14309/ajg.0000000000002801via CT.gov reference

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.