Overview

Treatment of Bile Acid Malabsorption With Liraglutide

Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
0
Participant gender:
All
Summary
Comparing the effect of Liraglutide on bile acid malabsorption, with colesevelam
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Filip Krag Knop
Collaborator:
Herlev and Gentofte Hospital
Treatments:
Bile Acids and Salts
Colesevelam Hydrochloride
Liraglutide
Criteria
Inclusion Criteria:

- • Caucasian ethnicity

- SeHCAT-verified moderate (5-10% bile acid retention after 7 days) or severe BAM
(<5% retention)

- Normal haemoglobin (for men 8.3-10.5 mmol/L; for women 7.3-9.5 mmol/L)

- Age above 18 years and below 75 years

- Informed and written consent

- BMI >18,5 kg/m2 and <40 kg/m2

- Glycated haemoglobin (HbA1c) <48 mmol/mol

Exclusion Criteria:

- • History of or present hepatobiliary disorder (except for non-alcoholic steatotic
liver disease) and/or alanine aminotransferase (ALAT) and/or serum aspartate
aminotransferase (ASAT) >3 times upper limit of normal) or history of hepatobiliary
disorder

- Gastrointestinal disease (except for BAM), previous intestinal resection or any
major intra-abdomial surgery

- Diabetes mellitus

- Nephropathy with eGFR < 60 mL/min/1.73m2

- Treatment with medicine that cannot be paused for 12 hours

- Hypothyroidism or hyperthyroidism, if not well regulated.

- Treatment with oral anticoagulants

- Active or recent malignant disease

- Any treatment or condition requiring acute or sub-acute medical or surgical
intervention

- Females of child-bearing potential who is pregnant (tested before entering the
study), breastfeeding or intend to become pregnant or is not using adequate
contraceptive methods, which includes Intrauterine Device (IUD), birth control
pills, sexual abstinence or living in a relationship with a sterile partner.

- Known or suspected hypersensitivity to trial products or related products

- Any condition considered incompatible with participation by the investigators