GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT03260881

CompletedPhase 4Results posted

Liraglutide Effects on Epicardial Fat Inflammatory Genes

Effects of Liraglutide on Epicardial Fat Pro-Inflammatory Genes in Type 2 Diabetes and Coronary Artery Disease

Lead sponsor

University of Miami

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Cardiovascular disease, Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•HbA1c ≤9%

Primary endpoint

•EAT Inflammation

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 IDNCT03260881

Org study ID20170684

Timeline

Milestones

Study first posted2017-08-24actual

Study start2018-09-01actual

Primary completion2024-09-05actual

Study completion2024-09-05actual

Last update posted2025-07-08actual

Results first posted2025-07-08actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Cardiovascular diseaseObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•T2DM as defined by American Diabetes Association (ADA) criteria

•Adult patients with T2DM who are indicated to receive liraglutide, not as first-line therapy, in addition to diet and exercise to improve glycemic control

•Hemoglobin A1c (HbA1c) ≤ 9%

•Age ≥ 18 years old

•Body mass index (BMI) ≥ 27 Kg/m2 and/or waist circumference ≥ 102 cm (40 inches) in men and 88 cm (35 inches) in women, respectively.

•Clinically and angiographically stable CAD who requires CABG as part of the standard medical care, as CAD does not represent a contraindication for using liraglutide. The stability of the CAD further warranties that study patients will not be exposed to higher risk by using liraglutide

Exclusion criteria

•Patients with a personal or family history of medullary thyroid carcinoma or patients with Multiple Endocrine Neoplasia syndrome type 2

•Patients with a prior serious hypersensitivity reaction to liraglutide

•Other contra-indications to liraglutide in accordance with risks and safety information included in the latest updated prescribing information

•Type 1 diabetes, as defined by ADA criteria

•Current use of other GLP-1A, dipeptidyl peptidase 4 (DPP4) or Sodium Glucose transporters 2 (SGLT2) inhibitors, thiazolidinediones (TZDs), pramlintide and fixed prandial insulin.

•Patients with unstable CAD, assessed by the Cardiology team and defined as new onset angina, rest angina, rapidly increasing or crescendo angina

•History of diabetic ketoacidosis, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy; acute or chronic infective diseases, cancer or chemotherapy, history of pulmonary, renal or liver diseases, and drug abuse

•Patients with chronic and acute inflammatory conditions such as sepsis, rheumatoid arthritis, ectopic dermatitis, asthma, ulcerative colitis.

•Current use of systemic corticosteroids in the 3 months prior this study.

•Pregnant or breast-feeding women

•Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice)

Endpoints (8)

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

Cardiometabolic biomarkers

Weight & body composition

Other (unclassified)

Weight & body composition

2 endpoints

Secondary/registry result

EAT Thickness

Time frame:Baseline and up to 12 weeks

Visceral fat, change

change from baseline, improvement

Posted result

Group	Value (mean), mm	95% CI
Study Group	11.8	—
Control Group	10	—

Secondary/protocol endpoint

EAT Thickness

Time frame:Baseline and up to 12 weeks

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints

Primary/registry result/low confidence

EAT Inflammation

Time frame:Up to 12 weeks

descriptive

Posted result

Group	Value (median), ct (cycle threshold)	95% CI
Study GroupmiR16	0.70	—
miR155	0.39	—
miR181-a	0.32	—
IL6	0.8	—
TNF-a	0.57	—
Control GroupmiR16	1.4	—
miR155	0.25	—
miR181-a	0.25	—
IL6	0.5	—
TNF-a	0.12	—

Primary/protocol endpoint/low confidence

EAT Inflammation

Time frame:Up to 12 weeks

descriptive

Secondary/registry result

SAT Inflammation

Time frame:Up to 12 weeks

SAT inflammation gene expression

change from baseline, improvement

Posted result

Group	Value (median), ct (cycle threshold)	95% CI
Study GroupmiR16	0.08	—
miR155	0.06	—
miR181a	0.12	—
Control GroupmiR16	0.17	—
miR155	0.04	—
miR181a	0.07	—

Secondary/protocol endpoint

SAT Inflammation

Time frame:Up to 12 weeks

descriptive

Other (unclassified)

2 endpoints

Secondary/registry result/low confidence

Epicardial Adipose Tissue Glucagon Like 1 Receptor (EAT-GLP-1R)

Time frame:Up to 12 weeks

descriptive

Secondary/protocol endpoint/low confidence

Epicardial Adipose Tissue Glucagon Like 1 Receptor (EAT-GLP-1R)

Time frame:Up to 12 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.