NCT01133522

Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults With Hyperlipidemia on Stable Doses of a Statin

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 145 in Subjects With Hyperlipidemia on Stable Doses of a Statin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety and tolerability of multiple doses of evolocumab when given as an add-on to stable statin therapy.

Detailed description

Participants receiving low-to-moderate-dose statins were randomized in a 1:3 ratio to receive subcutaneous placebo or evolocumab and enrolled sequentially into one of 5 dose-escalation cohorts: 1. Evolocumab 14 mg/placebo once weekly (QW) × 6 doses 2. Evolocumab 35 mg/placebo once weekly (QW) × 6 doses 3. Evolocumab 140 mg/placebo every 2 weeks (Q2W) × 3 doses 4. Evolocumab 280 mg/placebo every 2 weeks (Q2W) × 3 doses 5. Evolocumab 420 mg/placebo every 4 weeks (Q2W) × 2 doses. Participants receiving high-dose statins were randomized 1:3 to receive subcutaneous placebo or evolocumab 140 mg every 2 weeks × 3 doses (Cohort 6). Participants diagnosed with familial hypercholesterolemia (HeFH) were randomized 1:2 to receive subcutaneous placebo or evolocumab 140 mg every 2 weeks × 3 doses (Cohort 7).

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
BIOLOGICAL	Evolocumab	Administered by subcutaneous injection
BIOLOGICAL	Placebo	Administered by subcutaneous injection

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-09-14
• Completion: 2011-09-14
• First posted: 2010-05-31
• Last updated: 2018-11-02
• Results posted: 2015-10-22