Treatment of Bile Acid Malabsorption With Liraglutide

Bile Acid Malabsorption Clinical Trial

— BAM-LIRA  

Official title:

Treatment of Bile Acid Malabsorption With Liraglutide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955575
• Other study ID #: H-18048247
• Status: Completed
• Phase: Phase 4
• Start date: March 7, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 31, 2022
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bile Acid Malabsorption
• Malabsorption Syndromes

Intervention

Drug:
• Liraglutide 6 MG/ML
Liraglutide as injections.
• Colesevelam
3 x 625 miligram 2 times a day.

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Hellerup	Regionh

Sponsors (2)

Lead Sponsor	Collaborator
Filip Krag Knop	Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in stool fequency	Contestants will use a questionaire, which will be filled out three times during the 7 weeks periode	7 weeks
Secondary	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.	7 weeks
Secondary	Change in SeHCAT	Three SeHCAT scans will be made, and the difference will be evaluated	7 weeks
Secondary	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.	7 weeks