GLP-1 Peptide Atlas, by Delfa

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TerminatedPhase 2

Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients

Effect of GLP-1 Receptors Agonist Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Dyslipidemia, Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥30•HbA1c 7-8.5%

Primary endpoint

•Triglycerides, change

Identifiers

Registered as

NCT IDNCT02274740

Org study IDLIXISL07016

Secondary IDU1111-1153-3774UTN

Timeline

Milestones

Study first posted2014-10-24estimated

Last update posted2017-01-30estimated

Study start2015-04 (month precision)

Primary completion2015-08actual (month precision)

Study completion2015-08actual (month precision)

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

DyslipidemiaObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Male and female patients, 18-70 years of age.

Diagnosis of Type 2 diabetes treated with metformin and obesity (body mass index [BMI] >30 kg/m^2) and the following other abnormalities:

•Abdominal obesity (waist circumference >102 cm in men and >88 cm in women). According to National Cholesterol Education Program-Adult Treatment Panel (NCEP-ATP) III (2001).

•Glycated hemoglobin A1c (HbA1c) ≥7 and ≤8.5% (after Sponsor approval providers might reasonably suggest more stringent A1c goals [such as 6.5%] for selected individual patients, if this can be achieved without significant hypoglycemia or other adverse effects of treatment. Appropriate patients might include those with short duration of diabetes, long life expectancy, and no significant cardiovascular disease).

•Hypertriglyceridemia (fasting triglyceride levels between 150 mg/dL and 600 mg/dL, cholesterol <300 mg/dL. In order to exclude patients who might be suffering from a primitive dyslipidemia).

•Low high-density lipoprotein (HDL) cholesterol (serum HDL-cholesterol <40 mg/dL in men and <50 mg/dL in women).

Written informed consent.

Exclusion criteria

Smoking. Thyroid disease even if under appropriate hormonal replacement therapy or thyroid suppressant (Thyroid Stimulating Hormone [TSH] >5 mU/L with clinical symptoms of hypothyroidism).

Hepatic disease (Aspartate Aminotransferase [ASAT] or Alanine Aminotransferase [ALAT] >2 times the upper limit of normal).

Renal disease (serum creatinine >1.7 times the upper limit of normal). A history of coronary heart disease, cerebrovascular disease, or peripheral arterial disease in the 6 months before enrollment.

History of malignancies. Use of lipid lowering therapy. Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg. Triglycerides >600 mg/dL. History of chronic pancreatitis or of idiopathic acute pancreatitis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Endpoints (12)

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

Glycemic / diabetes

Other (unclassified)

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change from baseline in postprandial plasma glucose

Time frame:2 days after the basal test and after 10 weeks of treatment

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in insulin

Time frame:2 days after the basal test and after 10 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in C-peptide

Time frame:2 days after the basal test and after 10 weeks of treatment

C-peptide AUC

change from baseline, improvement

Cardiometabolic biomarkers

8 endpoints

Primary/protocol endpoint

Change in plasma triglycerides after 10 weeks of treatment area under-the-time concentration curve between 0 and 480 minutes (AUC0-480 min)

Time frame:After 10 weeks of treatment

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from baseline in plasma triglyceride

Time frame:2 days after the basal test and after 10 weeks of treatment

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from baseline in plasma cholesterol

Time frame:2 days after the basal test and after 10 weeks of treatment

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change from baseline in APO B48

Time frame:2 days after the basal test and after 10 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in free fatty acid levels

Time frame:2 days after the basal test and after 10 weeks of treatment

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in lipoprotein distribution

Time frame:2 days after the basal test and after 10 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in LDL oxidation

Time frame:2 days after the basal test and after 10 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in low grade inflammation (cytokines and stress oxidative markers)

Time frame:2 days after the basal test and after 10 weeks of treatment

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in baseline coronary flow reserve to assess the effect of lixisenatide on microvascular dysfunction

Time frame:2 days after the basal test and after 10 weeks of treatment

change from baseline, improvement

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.