CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 235 enrolled
Drug / intervention
Liraglutide +1 moredrug
Likely dose
Liraglutide 3.0 mg subcutaneously once daily (escalated over 4 weeks)AI-extracted
Key inclusion· 4
  • Age 35 years or older
  • BMI ≥30 kg/m² or BMI ≥27 kg/m² if metabolic syndrome present
  • Metabolic syndrome defined as ≥3 of: waist circumference >102 cm (men) or >88 cm (women), triglycerides >150 mg/dL or on treatment, HDL <40 mg/dL (men) or <50 mg/dL (women), BP >130/85 mmHg or on treatment, fasting glucose >100 mg/dL
  • Able to provide informed consent
Key exclusion· 16
  • Prior GLP-1 receptor agonists (liraglutide, exenatide, others), DPP-4 inhibitors, or insulin within last 3 months
  • Any anti-obesity drug or supplement within 1 month prior to screening
  • Weight fluctuation >5% within 3 months prior to screening
  • History of diabetes mellitus (type 1 or 2) or current anti-diabetes medication

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

Search/NCT03038620
NCT03038620Phase 4Completed

Impact of Liraglutide 3.0 on Body Fat Distribution, Visceral Adiposity, and Cardiometabolic Risk Markers In Overweight and Obese Adults at High Risk for Cardiovascular Disease

University of Texas Southwestern Medical Center·interventional·Posted Jan 31, 2017·Updated Nov 19, 2021

In Brief

A Phase 4 clinical trial evaluating Liraglutide and Placebo for Obesity, Visceral and 2 related conditions. Completed, enrolled 235 participants across 1 site.

Detailed Summary

This study is a clinical study to investigate the efficacy of liraglutide compared to placebo in reducing visceral adiposity measured by MRI in overweight or obese subjects at high risk for cardiovascular disease after 40 weeks on-treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNovo Nordisk A/S

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 31, 2017
Enrollment StartJan 1, 2017
Primary CompletionOct 13, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 9.4 years ago

Interventions

Liraglutidedrug

Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.

Placebodrug

Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.