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

Primary Purpose

Bile Acid Malabsorption

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Liraglutide 6 MG/ML
Colesevelam
Sponsored by
Filip Krag Knop
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bile Acid Malabsorption

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Liraglutide/placebo-colesevelam

Placebo-Liraglutide/colesevelam

Arm Description

Liraglutide as active and colesevelam as placebo

Liraglutide as placebo and colesevelam as placebo

Outcomes

Primary Outcome Measures

Change in stool fequency
Contestants will use a questionaire, which will be filled out three times during the 7 weeks periode

Secondary Outcome Measures

Total symptoms score, quality of life scores, and biomarker.
Total symptoms score, quality of life scores, and biomarker values will be analysed using a constrained linear mixed model with inherent baseline adjustment and with an unstructured covariance pattern. Changes since baseline within and between groups will be reported with 95% confidence intervals.
Change in SeHCAT
Three SeHCAT scans will be made, and the difference will be evaluated
Proportions of patients tolerating the treatment and proportion of patients experiencing remission of BAM related diarrhoea
Proportions of patients tolerating the treatment and proportion of patients experiencing remission of BAM related diarrhoea within each group will be reported with exact binomial confidence intervals and compared between groups using risk differences and Fisher's exact test.

Full Information

First Posted
March 8, 2019
Last Updated
June 1, 2022
Sponsor
Filip Krag Knop
Collaborators
Herlev and Gentofte Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03955575
Brief Title
Treatment of Bile Acid Malabsorption With Liraglutide
Acronym
BAM-LIRA
Official Title
Treatment of Bile Acid Malabsorption With Liraglutide
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 7, 2019 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Filip Krag Knop
Collaborators
Herlev and Gentofte Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Acid Malabsorption

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide/placebo-colesevelam
Arm Type
Active Comparator
Arm Description
Liraglutide as active and colesevelam as placebo
Arm Title
Placebo-Liraglutide/colesevelam
Arm Type
Active Comparator
Arm Description
Liraglutide as placebo and colesevelam as placebo
Intervention Type
Drug
Intervention Name(s)
Liraglutide 6 MG/ML
Intervention Description
Liraglutide as injections.
Intervention Type
Drug
Intervention Name(s)
Colesevelam
Intervention Description
3 x 625 miligram 2 times a day.
Primary Outcome Measure Information:
Title
Change in stool fequency
Description
Contestants will use a questionaire, which will be filled out three times during the 7 weeks periode
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Total symptoms score, quality of life scores, and biomarker.
Description
Total symptoms score, quality of life scores, and biomarker values will be analysed using a constrained linear mixed model with inherent baseline adjustment and with an unstructured covariance pattern. Changes since baseline within and between groups will be reported with 95% confidence intervals.
Time Frame
7 weeks
Title
Change in SeHCAT
Description
Three SeHCAT scans will be made, and the difference will be evaluated
Time Frame
7 weeks
Title
Proportions of patients tolerating the treatment and proportion of patients experiencing remission of BAM related diarrhoea
Description
Proportions of patients tolerating the treatment and proportion of patients experiencing remission of BAM related diarrhoea within each group will be reported with exact binomial confidence intervals and compared between groups using risk differences and Fisher's exact test.
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip K Knop, MD PhD
Organizational Affiliation
filip.krag.knop.01@regionh.dk
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gentofte Hospital
City
Hellerup
State/Province
Regionh
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Bile Acid Malabsorption With Liraglutide

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