Alirocumab and Reverse Cholesterol Transport

NCT03014830 | Completed Phase 1 FDA Drug

• 1 other identifier: 201612021
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atherosclerosis; Coronary Heart Disease

Outcome Measures

Primary Outcomes (2)

• Change from baseline in percent cholesterol excretion per day.

  Percent cholesterol excretion per day is defined as the percent of endogenous rapidly-mixing cholesterol pools excreted per day into the stool.

  Measurements made on days 13-15 (baseline) and days 55-57 (on treatment).

• Change from baseline in removal rate of esterified cholesterol from plasma per day.

  The removal rate of esterified cholesterol from plasma per day is defined as fractional removal rate of esterified cholesterol from the plasma in pools/day.

  Measurements made on days 1-3 (baseline) and days 43-45 (on treatment).

Secondary Outcomes (2)

• Change from baseline in LDL cholesterol

  Measurements made on day 15 (baseline) and day 57 (on treatment).

• Change from baseline in percent cholesterol absorption

  Measurements made on days 13-15 (baseline) and days 55-57 (on treatment).

Study Arms (2)

Alirocumab

ACTIVE COMPARATOR

Subjects will receive alirocumab for 6 weeks.

Drug: Alirocumab

Placebos

PLACEBO COMPARATOR

Subjects will receive placebo for 6 weeks.

Drug: Placebos

Interventions

Alirocumab DRUG

150 mg SQ every 2 weeks

Also known as: Praluent

Alirocumab

Placebos DRUG

Placebo injections SQ every 2 weeks

Also known as: Placebo

Placebos

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy or with stable medical or surgical illnesses
• LDL\>100 mg/dl.

You may not qualify if:

• Triglycerides\>250
• Taking drugs affecting lipid metabolism
• Elevated liver function tests
• Diabetes mellitus
• A1c 6.5% or greater
• Pregnant
• Breastfeeding
• Desire for conception in either sex.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Coronary Disease

Interventions

alirocumab

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases

Study Officials

• Richard E Ostlund, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: January 9, 2017
• Study Start: June 1, 2017
• Primary Completion: June 4, 2018
• Study Completion: July 30, 2018
• Last Updated: November 7, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)