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

NCT01859455 | Completed Phase 1

• 1 other identifier: CLGT209X2105
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypercholesterolemia; LDL Cholesterol

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Plasma concentrations of atorvastatin in patients

  2 weeks

• Plasma concentrations of simvastatin in patients

  2 weeks

• Serum concentrations of PCSK9

  12 weeks

Study Arms (5)

Patient: LGT209 50 mg

EXPERIMENTAL

50 mg LGT209 subcutaneous (SC) (1 mL injection x 1 site) in statin patients

Drug: LGT209 50 mg; Drug: Statins (atorvastatin or simvastatin)

Patient: LGT209 300 mg

EXPERIMENTAL

300 mg LGT209 subcutaneous (SC) (1 mL injection x 2 sites) in statin patients

Drug: LGT209 300 mg; Drug: Statins (atorvastatin or simvastatin)

Healthy Volunteers: LGT209 300 mg

EXPERIMENTAL

300 mg LGT209 or placebo subcutaneous (SC) (1 mL injection x 2 sites) in healthy volunteers

Drug: LGT209 300 mg

Patient: Placebo

PLACEBO COMPARATOR

matching placebo subcutaneous (SC) of LGT209 50 mg or 300 mg in statin patients

Drug: Placebo; Drug: Statins (atorvastatin or simvastatin)

Healthy volunteers: Placebo

PLACEBO COMPARATOR

matching placebo subcutaneous (SC) of LGT209 300 mg in healthy volunteers

Drug: Placebo

Interventions

LGT209 50 mg DRUG

Active experimental drug

Patient: LGT209 50 mg

LGT209 300 mg DRUG

Active experimental drug

Healthy Volunteers: LGT209 300 mg; Patient: LGT209 300 mg

Placebo DRUG

Placebo comparator

Healthy volunteers: Placebo; Patient: Placebo

Statins (atorvastatin or simvastatin) DRUG

Stable doses of atorvastatin or simvastatin

Also known as: Atorvastatin, Simvastatin

Patient: LGT209 300 mg; Patient: LGT209 50 mg; Patient: Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Fort Myers, Florida, 33901-8144, United States

Location

Novartis Investigative Site

Miramar, Florida, 33025, United States

Location

Related Links

• Results for CLGT209X2105 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Hypercholesterolemia; Hypercholesterolemia, Autosomal Dominant, 3

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Simvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 22, 2013
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 17, 2020

Record last verified: 2017-03

Locations

US (2)