Treatment of Bile Acid Malabsorption With Liraglutide

NCT03955575 | Completed Phase 4 DMC

• 1 other identifier: H-18048247
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bile Acid Malabsorption

Outcome Measures

Primary Outcomes (1)

• Change in stool fequency

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

  7 weeks

Secondary Outcomes (3)

• Total symptoms score, quality of life scores, and biomarker.

  7 weeks

• Change in SeHCAT

  7 weeks

• Proportions of patients tolerating the treatment and proportion of patients experiencing remission of BAM related diarrhoea

  7 weeks

Study Arms (2)

Liraglutide/placebo-colesevelam

ACTIVE COMPARATOR

Liraglutide as active and colesevelam as placebo

Drug: Liraglutide 6 MG/ML

Placebo-Liraglutide/colesevelam

ACTIVE COMPARATOR

Liraglutide as placebo and colesevelam as placebo

Drug: Colesevelam

Interventions

Liraglutide 6 MG/ML DRUG

Liraglutide as injections.

Liraglutide/placebo-colesevelam

Colesevelam DRUG

3 x 625 miligram 2 times a day.

Placebo-Liraglutide/colesevelam

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Filip Krag Knop: lead
• Herlev and Gentofte Hospital: collaborator

Study Sites (1)

Gentofte Hospital

Hellerup, Regionh, 2900, Denmark

Location

MeSH Terms

Interventions

Liraglutide; Colesevelam Hydrochloride

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Allylamine; Amines; Organic Chemicals; Allyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons

Study Officials

• Filip K Knop, MD PhD

  filip.krag.knop.01@regionh.dk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Consultant Endocrinologist, MD PhD

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: May 20, 2019
• Study Start: March 7, 2019
• Primary Completion: March 10, 2021
• Study Completion: May 31, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)