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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01859455
Recruitment Status : Completed
First Posted : May 22, 2013
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia LDL Cholesterol Drug: LGT209 50 mg Drug: LGT209 300 mg Drug: Placebo Drug: Statins (atorvastatin or simvastatin) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012


Arm Intervention/treatment
Experimental: Patient: LGT209 50 mg
50 mg LGT209 subcutaneous (SC) (1 mL injection x 1 site) in statin patients
Drug: LGT209 50 mg
Active experimental drug

Drug: Statins (atorvastatin or simvastatin)
Stable doses of atorvastatin or simvastatin
Other Names:
  • Atorvastatin
  • Simvastatin

Experimental: Patient: LGT209 300 mg
300 mg LGT209 subcutaneous (SC) (1 mL injection x 2 sites) in statin patients
Drug: LGT209 300 mg
Active experimental drug

Drug: Statins (atorvastatin or simvastatin)
Stable doses of atorvastatin or simvastatin
Other Names:
  • Atorvastatin
  • Simvastatin

Experimental: Healthy Volunteers: LGT209 300 mg
300 mg LGT209 or placebo subcutaneous (SC) (1 mL injection x 2 sites) in healthy volunteers
Drug: LGT209 300 mg
Active experimental drug

Placebo Comparator: Patient: Placebo
matching placebo subcutaneous (SC) of LGT209 50 mg or 300 mg in statin patients
Drug: Placebo
Placebo comparator

Drug: Statins (atorvastatin or simvastatin)
Stable doses of atorvastatin or simvastatin
Other Names:
  • Atorvastatin
  • Simvastatin

Placebo Comparator: Healthy volunteers: Placebo
matching placebo subcutaneous (SC) of LGT209 300 mg in healthy volunteers
Drug: Placebo
Placebo comparator




Primary Outcome Measures :
  1. Number of subjects (patients and healthy volunteers) with adverse events, serious adverse events and death [ Time Frame: 12 weeks ]
  2. Plasma concentrations of LGT209 following subcutaneous administration [ Time Frame: 12 weeks ]
  3. Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) concentration [ Time Frame: baseline and 12 weeks ]
  4. Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration [ Time Frame: baseline and 12 weeks ]

Secondary Outcome Measures :
  1. Plasma concentrations of atorvastatin in patients [ Time Frame: 2 weeks ]
  2. Plasma concentrations of simvastatin in patients [ Time Frame: 2 weeks ]
  3. Serum concentrations of PCSK9 [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859455


Locations
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United States, Florida
Novartis Investigative Site
Fort Myers, Florida, United States, 33901-8144
Novartis Investigative Site
Miramar, Florida, United States, 33025
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01859455    
Other Study ID Numbers: CLGT209X2105
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Hypercholesterolemia,
LDL cholesterol lowering,
proprotein convertase subtilisin/kexin type 9 (PCSK9),
LGT209,
drug safety,
pharmacokinetics,
pharmacodynamics
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors