Bile Acid MalabsorptionPhase 4BAM-LIRANCT03955575
Treatment of Bile Acid Malabsorption With Liraglutide
A Phase 4 study testing Liraglutide 6 MG/ML and Colesevelam in people with Bile Acid Malabsorption, run by Filip Krag Knop at 1 site in Denmark.
Trial summary
Comparing the effect of Liraglutide on bile acid malabsorption, with colesevelam Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bile Acid Malabsorption
- What is being tested?
- Liraglutide 6 MG/ML and Colesevelam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Mar 2019to 31 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Comparing the effect of Liraglutide on bile acid malabsorption, with colesevelam
Read the 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.
- Conditions
- Bile Acid Malabsorption
- Being tested
- Liraglutide 6 MG/ML, Colesevelam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide 6 MG/MLDrug
Liraglutide as injections.
ColesevelamDrug
3 x 625 miligram 2 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide/placebo-colesevelam | Active comparator | Liraglutide as active and colesevelam as placebo Receives: Drug: Liraglutide 6 MG/ML |
| Placebo-Liraglutide/colesevelam | Active comparator | Liraglutide as placebo and colesevelam as placebo Receives: Drug: Colesevelam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stool fequency
Contestants will use a questionaire, which will be filled out three times during the 7 weeks periode
Measured: 7 weeks
Secondary outcomes (3)
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.
Measured: 7 weeks
Change in SeHCAT
Three SeHCAT scans will be made, and the difference will be evaluated
Measured: 7 weeks
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.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start7 Mar 2019
- Primary completion10 Mar 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Acid MalabsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Filip Krag Knop
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev and Gentofte Hospital
- Responsible party
- Sponsor-investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
- Investigators
- Filip K Knop, MD PhD, Principal investigator, filip.krag.knop.01@regionh.dk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955575
- Sponsor's protocol ID
- H-18048247
- Acronym
- BAM-LIRA
- Status last verified
- Jun 2022
- First submitted
- 8 Mar 2019
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Bile Acid Malabsorption With Liraglutide
- ClinicalTrials.gov ID
- NCT03955575
- Acronym / sponsor ID
- BAM-LIRA / H-18048247
- Conditions
- Bile Acid Malabsorption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Filip Krag KnopUniversity, hospital or other
- Collaborators
- Herlev and Gentofte Hospital
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide/placebo-colesevelam | Active comparator | Drug: Liraglutide 6 MG/MLLiraglutide as active and colesevelam as placebo |
| Placebo-Liraglutide/colesevelam | Active comparator | Drug: ColesevelamLiraglutide as placebo and colesevelam as placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Caucasian ethnicity
Key exclusion criteria (12 listed)
- • 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liraglutide 6 MG/MLLiraglutide as injections. | Drug | Liraglutide/placebo-colesevelam |
| Colesevelam3 x 625 miligram 2 times a day. | Drug | Placebo-Liraglutide/colesevelam |
Primary outcome
Change in stool fequency
Time frame: 7 weeks
Contestants will use a questionaire, which will be filled out three times during the 7 weeks periode
3 secondary outcomes
Total symptoms score, quality of life scores, and biomarker.
Time frame: 7 weeks
Change in SeHCAT
Time frame: 7 weeks
Proportions of patients tolerating the treatment and proportion of patients experiencing remission of BAM related diarrhoea
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip K Knop, MD PhD principal investigator
filip.krag.knop.01@regionh.dk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide 6 MG/ML and Colesevelam in people with Bile Acid Malabsorption, run by Filip Krag Knop at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stool fequency (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.