DelfaGLP-1 Atlas

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CompletedPhase 4

Exenatide Compared With Insulin Glargine to Change Liver Fat Content in Type 2 Diabetes

Exenatide BID Compared With Insulin Glargine to Change Liver Fat Content in Non-alcoholic Fatty-liver Disease Patients With Type 2 Diabetes

Lead sponsor

Fudan University

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

5

Recruiting sites

—

Enrollment

76

actual

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥24•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 IDNCT02303730
Org study IDESR-14-10096

Timeline

Milestones

Study first posted2014-12-01estimated
Last update posted2019-08-28actual
Study start2015-03 (month precision)
Primary completion2017-11actual (month precision)
Study completion2017-11actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female, 18 ≤ age ≤ 70 years old.
•Newly diagnosed type 2 diabetes mellitus (WHO Diagnostic criteria for diabetes mellitus, 1999).
•Patients with NAFLD, MRS measurement of liver fat content> 10%.
•7% ≤ HbA1c ≤ 10%
•No heavy drinking history within the last 5 years (alcohol intake: male < 20 g/d, female < 10 g/d)
•HBsAg (-), hepatitis C virus antibody (HCV-Ab) (-)
•BMI ≥ 24 kg/m2;

Exclusion criteria

•Pregnancy, lactation, intended pregnancy, or failure to take adequate contraceptive measures taken (contraception measures including sterilization, intrauterine device, oral contraceptives, and persistent use of condoms).
•Type 1 diabetes mellitus, gestational diabetes mellitus or other special types of diabetes.
•Liver and renal dysfunction (ALT or aspartate aminotransferase(AST) is 2.5 times higher than the upper limit of normal, or total bilirubin is 1.5 times higher than the upper limit of normal, or Cr ≥ 115 μmol/L).
•increased amylase (blood amylase is 2.5 times higher than the upper limit of normal) or presence of gastrointestinal disease.
•Use of drugs that may affect liver fat content within one month before or during the trial period, such as glucocorticoids, thyroid hormone, etc.
•Use of GLP-1 receptor agonist, dipeptidyl peptidase -4 (DPP-4) inhibitors or insulin within 3 months before enrolment
•Presence of serious dyslipidemia or other endocrine diseases (hypothyroidism, hypothalamic-pituitary dysfunction, etc).
•Fatty liver caused by viral hepatitis, drug, alcohol, Wilson disease or total parenteral nutrition.
•Presence of liver cancer, infection, biliary tract disease or recently increased liver enzyme due to medication.
•Participation in strenuous exercise or administration of any drugs that affect glucose metabolism.
•History of pancreatitis, alcohol abuse, metal disorders or history of allergy to investigational drug.
•Congestive heart failure defined as New York Heart Association (NYHA) class III or IV, unstable angina or myocardial infarction in recent 6 months.
•Any situation that may affect the implementation or results of the study.

Endpoints (10)

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

Safety / tolerability / PK
3
Weight & body composition
2
Glycemic / diabetes
2
MASH / liver
1
Cardiometabolic biomarkers
1
Other (unclassified)
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change in intra-abdominal visceral fat content (cm2), abdominal subcutaneous fat content (cm2), and ratio between intra-abdominal visceral fat and subcutaneous fat area by MRI

Time frame:baseline and 24 weeks

change from baseline, improvement

componentsVisceral fat, change, Subcutaneous fat, change

Secondary/protocol endpoint

Change in body weight,waist circumference and hip circumference

Time frame:baseline and 24 weeks

change from baseline, improvement

componentsBody weight, absolute change (kg), Waist circumference, change

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change in glucose metabolism (fasting blood glucose, postprandial plasma glucose, HbA1c)

Time frame:baseline and 24 weeks

change from baseline, improvement

componentsFasting glucose, change, Postprandial glucose, HbA1c, change

Other/protocol endpoint

Change in β-cell function (fasting C-peptide, 2-hour postprandial C-peptide)

Time frame:baseline and 24 weeks

C-peptide AUC

change from baseline, improvement

MASH / liver

1 endpoint
Primary/protocol endpoint

Change in liver fat content（%） measured by MRS

Time frame:baseline and 24 weeks

Liver fat content, change

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change in blood lipid profile (total cholesterol, triglyceride, HDL, LDL)

Time frame:baseline and 24 weeks

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Other/protocol endpoint

Change in liver enzymes and laboratory parameters (hematology, biochemical tests)

Time frame:baseline and 24 weeks

change from baseline, descriptive

Other/protocol endpoint

Incidence of hypoglycaemia events

Time frame:up to 24 weeks

event count, event

Other/protocol endpoint

Incidence of adverse events（AEs）and Severe adverse events(SAEs)

Time frame:up to 24 weeks

Serious AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Other (unclassified)

1 endpoint
Other/protocol endpoint/low confidence

Change in cardiac function measured by echocardiography

Time frame:baseline and 24 weeks

change from baseline, improvement

Publications (11)

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.