Treatment of Bile Acid Malabsorption With Liraglutide (BAM-LIRA)

Filip Krag Knop

Status and phase: Completed; Phase 4

Conditions: Bile Acid Malabsorption

Treatments: Drug: Colesevelam; Drug: Liraglutide 6 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT03955575

H-18048247

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups

Liraglutide/placebo-colesevelam

Active Comparator group

Description:

Liraglutide as active and colesevelam as placebo

Treatment:

Drug: Liraglutide 6 MG/ML

Placebo-Liraglutide/colesevelam

Active Comparator group

Description:

Liraglutide as placebo and colesevelam as placebo

Treatment:

Drug: Colesevelam