Alirocumab and Reverse Cholesterol Transport

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT03014830
Phase
PHASE1
Status
Completed

Conditions

  • Atherosclerosis
  • Coronary Heart Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Alirocumab — DRUG
    150 mg SQ every 2 weeks
  • Placebos — DRUG
    Placebo injections SQ every 2 weeks

Study Details

Alirocumab is an injectable treatment for elevated blood cholesterol. The hypothesis of this study is that it also increases cholesterol excretion from the body into the stool, a process sometimes called reverse cholesterol transport. A cholesterol metabolic study will be done before and after 6 weeks of alirocumab treatment. If alirocumab increases reverse cholesterol transport, it is possible that this action provides additional protection from cardiovascular disease.

Key Dates

Start date
Jun 1, 2017
Status verified
Nov 2018
Primary completion
Jun 4, 2018
Completion
Jul 30, 2018

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Alirocumab
    Subjects will receive alirocumab for 6 weeks.
  • Placebo Comparator: Placebos
    Subjects will receive placebo for 6 weeks.

Primary Outcome Measure

Change from baseline in percent cholesterol excretion per day. [ Time Frame: Measurements made on days 13-15 (baseline) and days 55-57 (on treatment). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in St Louis, MO

By research site
Washington University School of Medicine· St Louis, MO

Related Studies