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Glucagon-like peptide-1 receptor agonist

Liraglutide Pen Injector for Ileal Pouchitis

Phase 2
Waitlist Available
Led By Hans Herfarth, MD, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4 and week 6 (treatment period 1) and week 10 and week 12 (treatment period 2)

Summary

This trial tests liraglutide, a medication that may reduce bowel movements, in patients with IPAA who have not responded to other treatments. The drug works by mimicking a natural hormone to slow digestion. Liraglutide has been used to treat diabetes and obesity by slowing stomach emptying and reducing high blood sugar.

Eligible Conditions
  • Ileal Pouchitis
  • Diverticulitis
  • Pouchitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4 and week 6 (treatment period 1) and week 10 and week 12 (treatment period 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4 and week 6 (treatment period 1) and week 10 and week 12 (treatment period 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 .
Secondary study objectives
Change in the 7 Day Mean Number of Day and Night Bowel Frequency at Week 4 and 6 vs Baseline on Liraglutide vs Placebo
Discontinuation of Therapy in Each Treatment Arm
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.

Side effects data

From 2023 Phase 1 & 2 trial • 27 Patients • NCT04199728
23%
Nausea
15%
Constipation
8%
Hiccups
8%
Continuing opioid withdrawal
8%
Knee pain
8%
Shakiness, diaphoresis, and tremor
8%
Insect bite
8%
Discomfort at Dexcom sensor site
8%
Overdose to illicit drug
8%
Ringing sensation
8%
Skin irritation spots
8%
Bruising at injection site
8%
GI/abdominal upset
8%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
Investigational Group

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo then LiraglutideExperimental Treatment2 Interventions
Participants will be randomly assigned to 6-week placebo treatment. Then after a 5-day washout, treatment will continue with 6 weeks of Liraglutide.
Group II: Liraglutide then PlaceboExperimental Treatment2 Interventions
Participants will be randomly assigned to 6-week Liraglutide treatment. Then after a 5-day washout, treatment will continue with 6 weeks of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liraglutide Pen Injector
2021
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,554 Previous Clinical Trials
4,293,125 Total Patients Enrolled
Novo Nordisk A/SIndustry Sponsor
1,552 Previous Clinical Trials
2,445,052 Total Patients Enrolled
Hans Herfarth, MD, PhDPrincipal InvestigatorUniversity of North Carolina
3 Previous Clinical Trials
196 Total Patients Enrolled

Media Library

Liraglutide Pen Injector (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04763564 — Phase 2
Ileal Pouchitis Research Study Groups: Liraglutide then Placebo, Placebo then Liraglutide
Ileal Pouchitis Clinical Trial 2023: Liraglutide Pen Injector Highlights & Side Effects. Trial Name: NCT04763564 — Phase 2
Liraglutide Pen Injector (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04763564 — Phase 2
~2 spots leftby Nov 2025
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