Clinical trial NCT03955575: Treatment of Bile Acid Malabsorption With Liraglutide
Official title: Treatment of Bile Acid Malabsorption With Liraglutide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bile Acid Malabsorption
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: Herlev and Gentofte Hospital
First posted: 2019-05-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Comparing the effect of Liraglutide on bile acid malabsorption, with colesevelam

Detailed description: The overall objective of the present study is to provide proof of concept that treatment with the GLP-1 receptor agonist liraglutide is efficacious (as assessed by symptom relief, i.e. response to treatment) and safe (as assessed by adverse effects) in the management of BAM and that it improves bile acid reabsorption (as assessed by SeHCAT) in these patients.

Eligibility 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

Primary outcomes:
measure: Change in stool fequency
timeFrame: 7 weeks
Secondary outcomes:
measure: Total symptoms score, quality of life scores, and biomarker.
timeFrame: 7 weeks
measure: Change in SeHCAT
timeFrame: 7 weeks
measure: Proportions of patients tolerating the treatment and proportion of patients experiencing remission of BAM related diarrhoea
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital
state: Regionh
Study officials:
affiliation: filip.krag.knop.01@regionh.dk
name: Filip K Knop, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: