DelfaGLP-1 Atlas

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LEAN

CompletedPhase 2

Liraglutide Efficacy and Action in Non-Alcoholic Steatohepatitis

48-week Phase II, Randomised, Double Blinded Placebo Controlled Multicentre Trial on Liraglutide's Safety, Efficacy and Action on Liver Histology and Metabolism in Overweight Patients With NASH +/- Type II Diabetes

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

52

actual

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight

Key I/E criterion

•BMI ≥25

Primary endpoint

•Liver Histological improvement

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 IDNCT01237119
Org study IDHE2013
Secondary IDISRCTN85774727ISRCTN

Timeline

Milestones

Study first posted2010-11-09estimated
Last update posted2016-03-23estimated
Study start2010-08 (month precision)
Primary completion2014-07actual (month precision)
Study completion2014-07actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•NASH on liver biopsy (within 6 months of screening visit).
•NAFLD Activity Score (NAS) ≥ 3, comprising of a minimum of 1 point from each of the individual steatosis, lobular inflammation and hepatocyte ballooning scores
•Body Mass Index (BMI) ≥ 25 at randomisation
•Type 2 Diabetes Mellitus/impaired glucose tolerance or normal glucose tolerance

Exclusion criteria

(brief):

•Insulin dependent diabetes
•Glycosylated Haemoglobin (HbA1c) > 9.0%
•treatment with dipeptidyl peptidase 4 (DPP-IV) inhibitors, Glucagon-like Peptides (GLP) 1 analogues, thiazolidinediones (TZDs)
•Past Medical History of Acute (or chronic) pancreatitis/pancreatic carcinoma, weight loss surgery, liver transplantation, Medullary thyroid cancer, hepatocellular carcinoma (HCC), Multiple Endocrine Neoplasia (MEN) syndrome, malignancy (within last 3 years, exception of treated skin malignancy)
•Other liver aetiologies (i.e. drug-induced, viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, haemochromatosis, alpha 1 anti-trypsin deficiency, Wilsons disease)
•concomitant or recent use of orlistat, prednisolone,
•Refusal or lacks capacity to give informed consent to participate in the trial
•Participation in any clinical trial of an investigational therapy or agent within 3 months of randomisation
•Patient (or carer) deemed not competent at using the correct site and technique for subcutaneous injection of the trial treatment (containing dummy drug on practice) at visit 2
•NAS<3
•Child's B or C cirrhosis
•Abnormal clinical examination of thyroid (i.e. unexplained goitre or palpable nodules)
•Liver enzymes > 10 x upper limit of normal
•Average alcohol consumption per week > 21 units (210g) male, >14 units (140g) female within the last 5 years.
•>5% weight loss since the diagnostic liver biopsy was obtained.
•Recent or concomitant use of steroids (oral), methotrexate, amiodarone, Orlistat
•Addition or significant change (as judged by the chief investigator) in dose of the following drugs; Angiotensin converting enzymes (ACE)-inhibitors, Angiotensin receptor blockers (ARBs) and/or Multi-vitamins (containing Vitamin E)
•Known positivity for antibody to Human Immunodeficiency virus (HIV)
•Serum creatinine > 150 μmol/L or currently being treated with renal replacement therapy
•Past medical history of multiple drug allergies (defined as anaphylactoid drug reactions in >2 drug groups)
•Presence of any acute/chronic infections or illness that at the discretion of the chief investigator might compromise the patient's health and safety in the trial
•Pregnancy or breastfeeding
•Women, of child-bearing age, who are not willing to practise effective contraception (i.e. barrier, oral contraceptive pill, implanon or history hysterectomy) for the 48 week duration of the trial and for one-month after the last administration of the drug.
•Men, sexually active with women of child-bearing age, who are not willing to practise effective contraception for the 48 week duration of the trial and for one-month after the last administration of the drug.

Endpoints (2)

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.

MASH / liver

2 endpoints
Primary/protocol endpoint/low confidence

Liver Histological improvement

Time frame:48 weeks

categorical status, improvement

Secondary/protocol endpoint

NAFLD Activity Score

Time frame:48 weeks

change from baseline, improvement

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.