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Cardiovascular Effects of GLP-1 Receptor Activation
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
329
actual
Study population
Obesity / overweight, Prediabetes / glucose intolerance
Key I/E criteria
•BMI ≥30•HbA1c 5.7-6.4%
Primary endpoints
•Flow-mediated Dilation•UACR, change•Plasminogen Activator Inhibitor-1
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Men and women,
2. Age 18 to 65 years, and
3. FPG (100-125 mg/dL) or, IGT (two-hour plasma glucose 140-199 mg/dL) or, HbA1C 5.7-6.4%
4. BMI≥30 kg/M2
5. The ability to provide informed consent before any trial-related activities.
Exclusion criteria
1. Diabetes type 1 or type 2, as defined by a FPG of 126 mg/dL or greater, a two-hour plasma glucose of 200 mg/dL or greater, or the use of anti-diabetic medication
2. Resistant hypertension, defined as hypertension requiring the administration of more than three anti-hypertensive agents including a diuretic to achieve control
3. Use of spironolactone
4. Known or suspected allergy to trial medications, excipients, or related products.
5. Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma
6. Personal history of non-familial medullary thyroid carcinoma
7. History of pancreatitis
8. Contraindications to study medications, worded specifically as stated in the product's prescribing information
9. Pregnancy or breast-feeding. Women of child-bearing potential will be required to have undergone tubal ligation or to be using an oral contraceptive or barrier methods of birth control
10. Subjects who have participated in a weight-reduction program during the last six month or whose weight has increased or decreased more than two kg over the preceding six months
11. Cardiovascular disease such as myocardial infarction within six months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (left ventricular hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
12. Treatment with anticoagulants
13. History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack
14. History or presence of immunological or hematological disorders
15. Diagnosis of asthma requiring regular inhaler use
16. Clinically significant gastrointestinal impairment that could interfere with drug absorption
17. Impaired hepatic function (aspartate amino transaminase [AST] and/or alanine amino transaminase [ALT] >3.0 x upper limit of normal range)
18. Individuals with an eGFR<30 mL/min/1.73 m2 or with a UACR >1000µg/mg, where eGFR is determined by the four-variable Modification of Diet in Renal Disease (MDRD) equation, where serum creatinine is expressed in mg/dL and age in years: eGFR (mL/min/1.73m2)=186 • Scr-1.154 • age-0.203 • (1.212 if black) • (0.742 if female)
19. Hematocrit <35%
20. Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
21. Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
22. Treatment with lithium salts
23. History of alcohol or drug abuse
24. Treatment with any investigational drug in the one month preceding the study
25. Previous randomization in this trial
26. Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study
27. Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Endpoints (16)
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 endpointsChange in Weight
Time frame:Change from baseline to 14 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Change in Weight
Time frame:Change from baseline to 14 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), kg | 95% CI |
|---|---|---|
| Liraglutide | -2.72 | — |
| Sitagliptin | -0.71 | — |
| Hypocaloric Diet | -4.95 | — |
Glycemic / diabetes
4 endpointsFasting Glucose
Time frame:Baseline, and after 2 weeks and 14 weeks of treatment
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), mg/dl | 95% CI |
|---|---|---|
| LiraglutideBaseline | 95.3 | — |
| 2 weeks | 84.26 | — |
| 14 weeks | 85.2 | — |
| SitagliptinBaseline | 97.6 | — |
| 2 weeks | 93.9 | — |
| 14 weeks | 96.6 | — |
| Hypocaloric DietBaseline | 94.5 | — |
| 2 weeks | 92.4 | — |
| 14 weeks | 91.2 | — |
Fasting Insulin
Time frame:Baseline, and after 2 weeks and 14 weeks of treatment
change from baseline, improvement
Posted result
| Group | Value (mean), uU/mL | 95% CI |
|---|---|---|
| LiraglutideBaseline | 22.7 | — |
| 2 weeks | 18.3 | — |
| 14 weeks | 20.3 | — |
| SitagliptinBaseline | 23.3 | — |
| 2 weeks | 29.4 | — |
| 14 weeks | 26.0 | — |
| Hypocaloric DietBaseline | 26.7 | — |
| 2 weeks | 19.7 | — |
| 14 weeks | 20.3 | — |
Fasting Glucose
Time frame:Baseline, and after 2 weeks and 14 weeks of treatment
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Fasting Insulin
Time frame:Baseline, and after 2 weeks and 14 weeks of treatment
concentration, descriptive
Renal / kidney
2 endpointsUrine Albumin-to-creatinine Ratio
Time frame:Baseline to 13 weeks
uACR, change
ratio, improvement
LOINC 9318-7
Posted result
| Group | Value (mean), mg/g | 95% CI |
|---|---|---|
| LiraglutideBaseline | 12.0 | — |
| 13 Weeks | 10.5 | — |
| SitagliptinBaseline | 7.9 | — |
| 13 Weeks | 9.2 | — |
| Hypocaloric DietBaseline | 6.3 | — |
| 13 Weeks | 10.1 | — |
Urine Albumin-to-creatinine Ratio
Time frame:Baseline to 13 weeks
uACR, change
ratio, improvement
LOINC 9318-7
Cardiometabolic biomarkers
8 endpointsChange in Flow-mediated Dilation
Time frame:Baseline to 2 and 14 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), Percentage | 95% CI |
|---|---|---|
| LiraglutideBaseline to 2 weeks (Placebo infusion) | 0.71 | — |
| Baseline to 2 weeks (Exendin infusion) | 0.48 | — |
| Baseline to 14 weeks (Placebo infusion) | 1.43 | — |
| Baseline to 14 weeks (Exendin infusion) | 1.73 | — |
| SitagliptinBaseline to 2 weeks (Placebo infusion) | 2.06 | — |
| Baseline to 2 weeks (Exendin infusion) | 0.13 | — |
| Baseline to 14 weeks (Placebo infusion) | 1.59 | — |
| Baseline to 14 weeks (Exendin infusion) | 1.42 | — |
| Hypocaloric DietBaseline to 2 weeks (Placebo infusion) | 1.24 | — |
| Baseline to 2 weeks (Exendin infusion) | 1.43 | — |
| Baseline to 14 weeks (Placebo infusion) | 1.01 | — |
| Baseline to 14 weeks (Exendin infusion) | 0.42 | — |
Change in Plasminogen Activator Inhibitor-1
Time frame:Baseline to 2 and 14 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), units/mL | 95% CI |
|---|---|---|
| LiraglutideBaseline to 2 weeks | -2.4 | — |
| Baseline to 14 weeks | -3.7 | — |
| SitagliptinBaseline to 2 weeks | -1.3 | — |
| Baseline to 14 weeks | 1.3 | — |
| Hypocaloric DietBaseline to 2 weeks | 1.1 | — |
| Baseline to 14 weeks | -3.6 | — |
Change in Flow-mediated Dilation
Time frame:Baseline to 2 and 14 weeks
change from baseline, improvement
Change in Plasminogen Activator Inhibitor-1
Time frame:Baseline to 2 and 14 weeks
change from baseline, improvement
Blood Pressure
Time frame:Baseline, and after 2 weeks and 14 weeks of treatment
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Posted result
| Group | Value (mean), mmHg | 95% CI |
|---|---|---|
| LiraglutideBaseline | 124.1 | — |
| 2 weeks | 122.9 | — |
| 14 weeks | 122.2 | — |
| SitagliptinBaseline | 120.2 | — |
| 2 weeks | 117.5 | — |
| 14 weeks | 118.2 | — |
| Hypocaloric DietBaseline | 127.7 | — |
| 2 weeks | 121.7 | — |
| 14 weeks | 119.7 | — |
Heart Rate
Time frame:Baseline, and after 2 weeks and 14 weeks of treatment
Heart rate, change
change from baseline, improvement
Posted result
| Group | Value (mean), Beats per minute | 95% CI |
|---|---|---|
| LiraglutideBaseline | 64.9 | — |
| 2 weeks | 68.9 | — |
| 14 weeks | 68.9 | — |
| SitagliptinBaseline | 67.2 | — |
| 2 weeks | 66.2 | — |
| 14 weeks | 65.9 | — |
| Hypocaloric DietBaseline | 63.8 | — |
| 2 weeks | 63.2 | — |
| 14 weeks | 61.7 | — |
Blood Pressure
Time frame:Baseline, and after 2 weeks and 14 weeks of treatment
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Heart Rate
Time frame:Baseline, and after 2 weeks and 14 weeks of treatment
Heart rate, change
change from baseline, improvement
Provenance
Sources
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.