Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)

Conditions

• Bowel Diseases, Inflammatory
• Pouch, Ileal
• Pouches, Ileoanal

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Tirzepatide — DRUG
  Tirzepatide will be administered subcutaneously
• Loperamide — DRUG
  2 mg orally every 6 hours as needed
• Diphenoxylate/Atropine — DRUG
  2 mg orally every 6 hours

Study Details

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.

Key Dates

First listed

Aug 10, 2026

Start date

Sep 30, 2026

Status verified

Aug 2026

Primary completion

Sep 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tirzepatide
  Treatment will start at 2.5 mg once weekly. After 4 weeks, the dose will be increased to 5 mg once weekly. After another 4 weeks, the dose will be increased to 7.5 mg once weekly for 4 weeks.
• Active Comparator: Optimized Standard of Care anti-diarrheal therapy
  Optimized regimen of loperamide 2 mg orally every 6 hours as needed for increased frequency or diphenoxylate/atropine can be given 2 mg orally every 6 hours. When using either or both therapies in combination the participant should not exceed a maximum dose of 16 mg orally within 24 hours. For participants with continued or worsening high bowel frequency for \>2 weeks, transition to active therapy with tirzepatide will be offered at week 4. Tirzepatide treatment would begin as 2.5 mg once weekly. After 4 weeks, the dose will be increased to 5 mg once weekly. After another 4 weeks, the dose will be increased to 7.5 mg once weekly for 4 weeks.

Primary Outcome Measure

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

Central Contacts

• Mikki Sandridge
  919-843-3873
  [email protected]

Locations (5)

Find similar trials in Beverly Hills, CA

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