DelfaGLP-1 Atlas

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LIGHT-ON

CompletedPhase 4

Efficacy Study of Liraglutide vs.Sitagliptin vs. Glargine on Liver Fat in T2DM Subjects

Efficacy of Liraglutide vs. Sitagliptin vs. Insulin Glargine Per Day on Liver Fat When Combined With Metformin in T2DM Subjects With Non-alcoholic Fatty-liver Disease

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

75

actual

Study population

MASH / NAFLD / liver fibrosis, Type 2 diabetes

Key I/E criteria

•BMI ≤10•HbA1c ≤10%

Primary endpoint

•Liver fat content, change

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 IDNCT02147925
Org study IDIIS201404

Timeline

Milestones

Study first posted2014-05-28estimated
Last update posted2018-05-18actual
Study start2014-08 (month precision)
Primary completion2017-04actual (month precision)
Study completion2017-04actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisType 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Recorded Type 2 diabetes diagnosed at least 3 months before the study; At least 3 months treatment on a stable dose（≧1500mg/d）of metformin before the study
•6.5%<HbA1c ≤10%
•Clinically diagnosed simple liver steatosis
•30-75 years old
•Female subjects should be postmenopausal, surgically sterile, or using contraceptives for 3 months before screening and continuing throughout the study;
•BMI 20~35 kg/m2 and with a history of stable body weight (≤10%variation for ≥3 months)
•intrahepatic lipids (IHL) >10%

Exclusion criteria

•Type 1 diabetes
•Treatment within the last 3 months with Thiazolidinediones(TZDs), orlistat, insulin, any history of incretin based therapy or any other drugs associated with hepatic steatosis (including but not limited to glucocorticoids, tamoxifen, amiodarone or methotrexate)
•History or current episode of pancreatitis or other disease of the pancrea; Impaired liver function, defined as plasma alanine transaminase(ALT) >2.5 times of upper normal limit
•Moderate and severe renal insufficiency defined as MDRD formula glomerular filtration rate<60ml/min/1.73m2
•Weekly alcohol intake>14 units for women or >21 units for men
•Any history of liver disease including metabolic or auto-immune liver diseases or viral hepatitis
•History or family history of medullary thyroid cancer(MTC), or multiple endocrine neoplasia type 2(MEN-2)
•Congestive heart failure(NYHA III~IV)
•Severe gastric-intestinal diseases
•Pregnancy and/or intention of becoming pregnant
•Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator; Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content. Herbal traditional Chinese medicine or other local herbal medicines may, at the Investigator's discretion, be continued throughout the trial at an unchanged dose

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

Weight & body composition
2
Glycemic / diabetes
1
MASH / liver
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change of abdominal subcutaneous adipose tissue(SAT)

Time frame:26 weeks

Subcutaneous fat, change

change from baseline, improvement

Secondary/protocol endpoint

Change of visceral adipose tissue(VAT)

Time frame:26 weeks

Visceral fat, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change in hemoglobin A1c(HbA1c)

Time frame:26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

1 endpoint
Primary/protocol endpoint

Intrahepatic lipids (IHL)

Time frame:26-week

Liver fat content, change

change from baseline, improvement

Publications (10)

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.