Treatment of bile acid malabsorption with liraglutid

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003575-34-DK

Enrollment

Registered

2018-10-19

Start date

2018-11-29

Completion date

Unknown

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile acid malabsoprtion is a disease in which there is a large spill-over of bileacids to the larger intestines. This causes watery diarrheas and abdominal symptoms. MedDRA version: 20.1 Level: LLT Classification code 10080051 Term: Bile acid diarrhoea System Organ Class: 100000004856

Interventions

Trade Name: Victoza Pharmaceutical Form: Injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Subcutaneous use Trade Name: Cholestagel Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Caucasian ethnicity • SeHCAT-verified moderate (5–10% bile acid retention after 7 days) or severe type 2 BAM (18,5 kg/m2 and =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

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-abdominal surgery • Diabetes mellitus • Nephropathy with eGFR < 30 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 • Female of child-bearing potential who is pregnant, breastfeeding or intend to become pregnant or is not using adequate contraceptive methods, which includes Intrauterine Device (IUD) og birth control pills. • Known or suspected hypersensitivity to trial products or related products • Any condition considered incompatible with participation by the investigators

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to examine the influence of liraglutide on individuals suffering from bile acid malabsorption (BAM), in a randomised double-blinded, double dummy parallel Group non-inferiority study. ;Secondary Objective: Not applicable;Primary end point(s): The primary end-point is proportion of patients experiencing response to treatment (i.e. >25% reduction in stool frequency) in the end of the 6-week intervention period; non-inferiority between the two groups. Daily symptom diaries will be used to record stool frequency. ;Timepoint(s) of evaluation of this end point: Patients will be asked to record any adverse events in their symptom diaries. The symptoms diaries will be filled in on a daily basis during weeks -1, 1, 3 and 6.	—

Measure

Time frame

Main Objective: The aim of this study is to examine the influence of liraglutide on individuals suffering from bile acid malabsorption (BAM), in a randomised double-blinded, double dummy parallel Group non-inferiority study. ;Secondary Objective: Not applicable;Primary end point(s): The primary end-point is proportion of patients experiencing response to treatment (i.e. >25% reduction in stool frequency) in the end of the 6-week intervention period; non-inferiority between the two groups. Daily symptom diaries will be used to record stool frequency. ;Timepoint(s) of evaluation of this end point: Patients will be asked to record any adverse events in their symptom diaries. The symptoms diaries will be filled in on a daily basis during weeks -1, 1, 3 and 6.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints encompass: • Stool consistency as assessed by the Bristol Stool-form Scale • Proportion of patients experiencing remission of type 2 BAM-related diarrhea (<2 formed or semi-formed stools per day) • Symptomatic relief of BAM symptoms as assessed by The Gastrointestinal Symptom Rating Scale-IBS (GSRS-IBS) and The IBS Severity Scoring System (IBS-SSS) • Proportion of patients tolerating treatment (i.e. maintaining treatment throughout the 6-week treatment period) and not tolerating treatment, respectively • Change in health-related quality of life score as assessed by SF-36v2(37). Further secondary endpoints include • Change in percent retention of bile acid (as assessed by SeHCAT) from baseline, proportions of patients 1) improving their BAM severity (from moderate BAM to normal condition or from severe BAM to moderate BAM or normal condition (as assessed by SeHCAT)), 2) experiencing no change in BAM category (as assessed by SeHCAT) and 3) experiencing deterioration in BAM category (i.e. from moderate to severe BAM as assessed by SeHCAT). Of note, SeHCAT results represent exploratory secondary endpoints as BAS treatment - in contrast to liraglutide treatment - is expected to reduce retention of bile acids. For the same reason retention of bile acid as assessed by SeHCAT cannot be used as a primary. • Fasting serum/plasma concentrations of total bile acids, fractionated bile acids, cholesterol profile, triglycerides, free fatty acids, C4 (marker of bile acid synthesis), FGF19, glucose, glycated haemoglobin A1c (HbA1c), insulin, C-peptide and glucagon. • Faecal content of bile acids and microbiota composition will be evaluated as exploratory endpoints. ;Timepoint(s) of evaluation of this end point: Questionaries: week -1(baseline), 1,3,6 SeHCAT, blodsamples and faeces samples: Week -1(baseline), 3 and 6	—

Measure

Time frame

Secondary end point(s): Secondary endpoints encompass: • Stool consistency as assessed by the Bristol Stool-form Scale • Proportion of patients experiencing remission of type 2 BAM-related diarrhea (<2 formed or semi-formed stools per day) • Symptomatic relief of BAM symptoms as assessed by The Gastrointestinal Symptom Rating Scale-IBS (GSRS-IBS) and The IBS Severity Scoring System (IBS-SSS) • Proportion of patients tolerating treatment (i.e. maintaining treatment throughout the 6-week treatment period) and not tolerating treatment, respectively • Change in health-related quality of life score as assessed by SF-36v2(37). Further secondary endpoints include • Change in percent retention of bile acid (as assessed by SeHCAT) from baseline, proportions of patients 1) improving their BAM severity (from moderate BAM to normal condition or from severe BAM to moderate BAM or normal condition (as assessed by SeHCAT)), 2) experiencing no change in BAM category (as assessed by SeHCAT) and 3) experiencing deterioration in BAM category (i.e. from moderate to severe BAM as assessed by SeHCAT). Of note, SeHCAT results represent exploratory secondary endpoints as BAS treatment - in contrast to liraglutide treatment - is expected to reduce retention of bile acids. For the same reason retention of bile acid as assessed by SeHCAT cannot be used as a primary. • Fasting serum/plasma concentrations of total bile acids, fractionated bile acids, cholesterol profile, triglycerides, free fatty acids, C4 (marker of bile acid synthesis), FGF19, glucose, glycated haemoglobin A1c (HbA1c), insulin, C-peptide and glucagon. • Faecal content of bile acids and microbiota composition will be evaluated as exploratory endpoints. ;Timepoint(s) of evaluation of this end point: Questionaries: week -1(baseline), 1,3,6 SeHCAT, blodsamples and faeces samples: Week -1(baseline), 3 and 6

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Countries

Denmark

Contacts

Public ContactStene Diabetes Center Copenhagen,

Gentofte Hospital, University of Copenhagen

filip.krag.knop.01@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026