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

Phase 1

Completed

• Conditions: Hypercholesterolemia; LDL Cholesterol
• Interventions: Drug: LGT209 50 mg; Drug: LGT209 300 mg; Drug: Placebo; Drug: Statins (atorvastatin or simvastatin)

• Registration Number: NCT01859455
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2013-05-09
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-22
• Status Verified: 2017-03
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient: LGT209 50 mg	LGT209 50 mg	50 mg LGT209 subcutaneous (SC) (1 mL injection x 1 site) in statin patients
Patient: LGT209 50 mg	Statins (atorvastatin or simvastatin)	50 mg LGT209 subcutaneous (SC) (1 mL injection x 1 site) in statin patients
Patient: LGT209 300 mg	LGT209 300 mg	300 mg LGT209 subcutaneous (SC) (1 mL injection x 2 sites) in statin patients
Patient: LGT209 300 mg	Statins (atorvastatin or simvastatin)	300 mg LGT209 subcutaneous (SC) (1 mL injection x 2 sites) in statin patients
Healthy Volunteers: LGT209 300 mg	LGT209 300 mg	300 mg LGT209 or placebo subcutaneous (SC) (1 mL injection x 2 sites) in healthy volunteers
Patient: Placebo	Placebo	matching placebo subcutaneous (SC) of LGT209 50 mg or 300 mg in statin patients
Patient: Placebo	Statins (atorvastatin or simvastatin)	matching placebo subcutaneous (SC) of LGT209 50 mg or 300 mg in statin patients
Healthy volunteers: Placebo	Placebo	matching placebo subcutaneous (SC) of LGT209 300 mg in healthy volunteers

Primary Outcome Measures

Name	Time	Method
Number of subjects (patients and healthy volunteers) with adverse events, serious adverse events and death	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
Plasma concentrations of LGT209 following subcutaneous administration	12 weeks

Secondary Outcome Measures

Name	Time	Method
Serum concentrations of PCSK9	12 weeks
Plasma concentrations of atorvastatin in patients	2 weeks
Plasma concentrations of simvastatin in patients	2 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Miramar, Florida, United States