Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins

A Randomized, Double-blind, Placebo-controlled, Single Dose, Parallel Group Study to Assess the Safety, Tolerability, Bioavailability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous LGT209 in Hypercholesterolemic Patients on Stable Doses of Atorvastatin or Simvastatin and in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01859455

Enrollment

Registered

2013-05-22

Start date

2011-07-31

Completion date

2012-07-31

Last updated

2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia, LDL Cholesterol

Keywords

Hypercholesterolemia,, LDL cholesterol lowering,, proprotein convertase subtilisin/kexin type 9 (PCSK9),, LGT209,, drug safety,, pharmacokinetics,, pharmacodynamics

Brief summary

This study is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of LGT209 in hypercholesterolemic patients taking common statin medications and in healthy volunteers.

Interventions

DRUGLGT209 50 mg

Active experimental drug

DRUGLGT209 300 mg

Active experimental drug

DRUGPlacebo

Placebo comparator

DRUGStatins (atorvastatin or simvastatin)

Stable doses of atorvastatin or simvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers: Male and female subjects 18 to 70 years of age, in general good health with fasting LDL-cholesterol \>90 mg/dL and fasting serum triglycerides \<400 mg/dL * Patients on statin therapy: Male and female patients 18 to 70 years of age receiving atorvastatin or simvastatin and with fasting LDL-cholesterol \>90 mg/dL and fasting serum triglycerides \<400 mg/dL

Exclusion criteria

Healthy volunteers: * History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes * Women of child-bearing potential unless using highly effective methods of contraception * Conditions which might impact the safety or biologic activity of the study drug Statin patients: * Use of concomitant medications known to impact the safe use or efficacy of atorvastatin and simvastatin based on drug labels * Women of childbearing potential unless using highly effective methods of contraception during dosing and for at least 100 days after study drug administration * Conditions which might impact the safety or biologic activity of the study drug Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Number of subjects (patients and healthy volunteers) with adverse events, serious adverse events and death	12 weeks
Plasma concentrations of LGT209 following subcutaneous administration	12 weeks
Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) concentration	baseline and 12 weeks
Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration	baseline and 12 weeks

Secondary

Measure	Time frame
Plasma concentrations of simvastatin in patients	2 weeks
Serum concentrations of PCSK9	12 weeks
Plasma concentrations of atorvastatin in patients	2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026