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GLP-1 Agonist

Liraglutide for Coronary Heart Disease

University of Miami, Miami, FL
Targeting 2 different conditionsLiraglutide Pen Injector [Victoza] +1 morePhase 4RecruitingLed by Gianluca Iacobellis, MD PhDResearch Sponsored by University of Miami

Study Summary

This trial will test whether the anti-diabetic medication liraglutide can reduce the risk of cardiovascular disease by reducing inflammation in the Epicardial Adipose Tissue (EAT).

Eligible Conditions
  • Coronary Artery Disease
  • Type 2 Diabetes

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have type 2 diabetes as diagnosed by the American Diabetes Association criteria.
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Your hemoglobin A1c level is less than or equal to 9%.
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Adults with type 2 diabetes who need to take liraglutide, along with diet and exercise, to control their blood sugar.
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You have a higher than normal body mass index (BMI) or waist circumference.
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You have stable coronary artery disease and may need coronary artery bypass grafting (CABG) as part of your regular medical care. This condition won't stop you from using liraglutide, and your heart condition won't be at higher risk by taking liraglutide.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from a minimum of 4 weeks up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from a minimum of 4 weeks up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
EAT inflammation
Secondary outcome measures
EAT GLP-1R
EAT thickness
SAT inflammation

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: L-groupActive Control1 Intervention
• L-group will be started on liraglutide. Liraglutide will be started and administered for from a minimum of 4 weeks up to 12 weeks prior to CABG with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). The dose of 1.8 mg daily will be maintained until the end of the 12-week study. Other and current diabetes treatment will be continued
Group II: D-groupPlacebo Group1 Intervention
placebo will be administered in addition to current treatment prior to the CABG with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). D-group will be started on a supervised low calorie diet (LCD) to achieve approximately 5% of weight loss after from a minimum of 4 weeks up to 12 weeks.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
876 Previous Clinical Trials
407,747 Total Patients Enrolled
4 Trials studying Coronary Artery Disease
585 Patients Enrolled for Coronary Artery Disease
Novo Nordisk A/SIndustry Sponsor
1,476 Previous Clinical Trials
2,368,536 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
2,000 Patients Enrolled for Coronary Artery Disease
Gianluca Iacobellis, MD PhD4.98 ReviewsPrincipal Investigator - University of Miami
University of Miami
2 Previous Clinical Trials
80 Total Patients Enrolled
5Patient Review
This doctor is excellent!!

Media Library

Liraglutide (GLP-1 Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03260881 — Phase 4
Coronary Artery Disease Research Study Groups: L-group, D-group
Coronary Artery Disease Clinical Trial 2023: Liraglutide Highlights & Side Effects. Trial Name: NCT03260881 — Phase 4
Liraglutide (GLP-1 Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03260881 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What indications might necessitate the use of L-group medications?

"L-group can be employed to assist with cardio risk minimisation, physical fitness and reducing the impact of single drug therapy."

Answered by AI

Is this research study still recruiting participants?

"As detailed by clinicaltrials.gov, the enrollment for this medical trial is now open to participants. The study was first made available on September 1st 2018 and underwent its most recent edit in November 4th 2022."

Answered by AI

Could you provide a tally of participants in this research study?

"Correct. Recent information from clinicaltrials.gov confirms that this research is still seeking participants, having first been posted on September 1st 2018 and revised as recently as November 4th 2022. 40 persons need to be recruited at a single site."

Answered by AI

Are there any potential health risks associated with using L-group medications?

"There is a considerable amount of data that attests to the safety of L-group, resulting in it receiving a score of 3. This Phase 4 trial confirms its approval as an effective treatment option."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Liraglutide Effects on Epicardial Fat Inflammatory Genes
Gianluca Iacobellis 2018. "Liraglutide Effects on Epicardial Fat Inflammatory Genes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03260881.
All > Coronary Artery Disease > Victoza
~1 spots leftby Dec 2023
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