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The Effects of Evolocumab in Patients With Diabetes and Atherosclerotic Vascular Disease

NCT03829046 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-04-28

Study results available
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Summary

Experimental models have linked lipid lowering therapies with systemic inflammation; however, relatively little is known about this network in clinical populations and specifically how it changes with PCSK9 inhibition. The eligible subjects will have 6 visits in 13 to 16 weeks and will have Repatha/placebo 140mg subcutaneous every 4 weeks for 3 times since randomization visit, blood tests will be done in each visit to evaluate the effects of evolocumab upon biocellular markers potentially altered by PCSK9 inhibition in a population of type 2 diabetes patients with microvascular dysfunction.

Primary Aims:

Determine the ACUTE and SHORT-TERM effects of PCSK9 inhibition with evolocumab on biocellular markers of inflammation, immune mediated thrombosis and rheology. The data from this trial will be used to support a clinical trial to assess the role of PCSK9 inhibition in type 2 diabetes patients with cardiac microvascular dysfunction.

Secondary Aims:

1. To define the association between PCSK 9 concentrations and immune-related phenotype.
2. To define the association between Lp(a) concentrations, oxidized phospholipids (OxPL), ApoB, biocellular markers of inflammation, tissue factor and immunothrombosis.

Conditions

  • Atherosclerotic Vascular Disease
  • Type2 Diabetes
  • Microvascular Dysfunction

Interventions

DRUG

Placebo

12 weeks of treatment

DRUG

Evolocumab

12 weeks of treatment

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • University of Toronto

    collaborator OTHER

  • University of Michigan

    collaborator OTHER

  • Robert Rosenson

    lead OTHER

Principal Investigators

  • Robert Rosenson, MD · Icahn School of Medicine at Mount Sinai

  • Kim A Connelly, MD · St. Michael's Hospital at University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2021-11-15
Completion
2021-11-15
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03829046 on ClinicalTrials.gov