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BAM-LIRA

CompletedPhase 4

Treatment of Bile Acid Malabsorption With Liraglutide

Lead sponsor

Filip Krag Knop

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Gastrointestinal (gastroparesis / short bowel / pancreatitis)

Key I/E criterion

•BMI 18.5-40

Primary endpoint

•Stool fequency

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03955575

Org study IDH-18048247

Timeline

Milestones

Study start2019-03-07actual

Study first posted2019-05-20actual

Primary completion2021-03-10actual

Study completion2022-05-31actual

Last update posted2022-06-03actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Gastrointestinal (gastroparesis / short bowel / pancreatitis)

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

Other clinical outcomes

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint/low confidence

Change in stool fequency

Time frame:7 weeks

change from baseline, descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint/low confidence

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

Time frame:7 weeks

threshold achievement, improvement

componentstreatment tolerability, diarrhea remission

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

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

Time frame:7 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in SeHCAT

Time frame:7 weeks

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.