← Trials/Trial dossier/NCT03101930

CompletedPhase 4Results posted

Cardiovascular Effects of GLP-1 Receptor Activation

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 ≥30HbA1c 5.7-6.4%

Primary endpoints

Flow-mediated DilationUACR, changePlasminogen 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

NCT IDNCT03101930
Org study IDIRB# 170213

Timeline

Milestones

Study first posted2017-04-05actual
Study start2017-05-01actual
Primary completion2021-06-24actual
Study completion2021-06-24actual
Results first posted2022-08-16actual
Last update posted2022-10-18actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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

Cardiometabolic biomarkers
8
Glycemic / diabetes
4
Weight & body composition
2
Renal / kidney
2

Weight & body composition

2 endpoints
Other/protocol endpoint

Change in Weight

Time frame:Change from baseline to 14 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Other_pre_specified/registry result

Change in Weight

Time frame:Change from baseline to 14 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kg95% CI
Liraglutide-2.72
Sitagliptin-0.71
Hypocaloric Diet-4.95

Glycemic / diabetes

4 endpoints
Secondary/registry result

Fasting 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

GroupValue (mean), mg/dl95% CI
LiraglutideBaseline95.3
2 weeks84.26
14 weeks85.2
SitagliptinBaseline97.6
2 weeks93.9
14 weeks96.6
Hypocaloric DietBaseline94.5
2 weeks92.4
14 weeks91.2
Secondary/registry result

Fasting Insulin

Time frame:Baseline, and after 2 weeks and 14 weeks of treatment

change from baseline, improvement

Posted result

GroupValue (mean), uU/mL95% CI
LiraglutideBaseline22.7
2 weeks18.3
14 weeks20.3
SitagliptinBaseline23.3
2 weeks29.4
14 weeks26.0
Hypocaloric DietBaseline26.7
2 weeks19.7
14 weeks20.3
Secondary/protocol endpoint

Fasting Glucose

Time frame:Baseline, and after 2 weeks and 14 weeks of treatment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Fasting Insulin

Time frame:Baseline, and after 2 weeks and 14 weeks of treatment

concentration, descriptive

Renal / kidney

2 endpoints
Primary/registry result

Urine Albumin-to-creatinine Ratio

Time frame:Baseline to 13 weeks

uACR, change

ratio, improvement

LOINC 9318-7

Posted result

GroupValue (mean), mg/g95% CI
LiraglutideBaseline12.0
13 Weeks10.5
SitagliptinBaseline7.9
13 Weeks9.2
Hypocaloric DietBaseline6.3
13 Weeks10.1
Primary/protocol endpoint

Urine Albumin-to-creatinine Ratio

Time frame:Baseline to 13 weeks

uACR, change

ratio, improvement

LOINC 9318-7

Cardiometabolic biomarkers

8 endpoints
Primary/registry result/low confidence

Change in Flow-mediated Dilation

Time frame:Baseline to 2 and 14 weeks

change from baseline, improvement

Posted result

GroupValue (mean), Percentage95% 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
Primary/registry result

Change in Plasminogen Activator Inhibitor-1

Time frame:Baseline to 2 and 14 weeks

change from baseline, improvement

Posted result

GroupValue (mean), units/mL95% CI
LiraglutideBaseline to 2 weeks-2.4
Baseline to 14 weeks-3.7
SitagliptinBaseline to 2 weeks-1.3
Baseline to 14 weeks1.3
Hypocaloric DietBaseline to 2 weeks1.1
Baseline to 14 weeks-3.6
Primary/protocol endpoint

Change in Flow-mediated Dilation

Time frame:Baseline to 2 and 14 weeks

change from baseline, improvement

Primary/protocol endpoint

Change in Plasminogen Activator Inhibitor-1

Time frame:Baseline to 2 and 14 weeks

change from baseline, improvement

Secondary/registry result

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

GroupValue (mean), mmHg95% CI
LiraglutideBaseline124.1
2 weeks122.9
14 weeks122.2
SitagliptinBaseline120.2
2 weeks117.5
14 weeks118.2
Hypocaloric DietBaseline127.7
2 weeks121.7
14 weeks119.7
Secondary/registry result

Heart Rate

Time frame:Baseline, and after 2 weeks and 14 weeks of treatment

Heart rate, change

change from baseline, improvement

Posted result

GroupValue (mean), Beats per minute95% CI
LiraglutideBaseline64.9
2 weeks68.9
14 weeks68.9
SitagliptinBaseline67.2
2 weeks66.2
14 weeks65.9
Hypocaloric DietBaseline63.8
2 weeks63.2
14 weeks61.7
Secondary/protocol endpoint

Blood Pressure

Time frame:Baseline, and after 2 weeks and 14 weeks of treatment

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Heart Rate

Time frame:Baseline, and after 2 weeks and 14 weeks of treatment

Heart rate, change

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 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.