CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 329 enrolled
Drug / intervention
Liraglutide +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03101930
NCT03101930Phase 4Completed
CompareCT.gov

Cardiovascular Effects of GLP-1 Receptor Activation

Vanderbilt University Medical Center·interventional·Posted Apr 5, 2017·Updated Oct 18, 2022

In Brief

A Phase 4 clinical trial evaluating Liraglutide, Sitagliptin, and 3 other interventions for Obesity and PreDiabetes. Completed, enrolled 329 participants across 1 site.

Detailed Summary

This project tests the principle hypothesis that stable glucagon like peptide-1 (GLP-1) analogues have specific GLP1R-dependent beneficial effects on vascular endothelial function, fibrinolysis and inflammation in obesity that exceed the benefits of weight loss, and that genetic or other individual factors that modulate GLP1R sensitivity can modify the effect of these analogues on cardiovascular risk.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, PreDiabetes
CountriesUnited States
CollaboratorsAmerican Heart Association

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 5, 2017
Enrollment StartMay 1, 2017
Primary CompletionJun 24, 2021
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 9.2 years ago

Interventions

Liraglutidedrug

subcutaneous liraglutide daily

Sitagliptindrug

oral sitagliptin daily

hypocaloric dietother

Reduced calorie intake to achieve weight loss.

Placebosdrug

Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.

Exendin (9-39)drug

All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.