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

Primary Purpose

Hypercholesterolemia, LDL Cholesterol

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LGT209 50 mg
LGT209 300 mg
Placebo
Statins (atorvastatin or simvastatin)
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hypercholesterolemia,, LDL cholesterol lowering,, proprotein convertase subtilisin/kexin type 9 (PCSK9),, LGT209,, drug safety,, pharmacokinetics,, pharmacodynamics

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Patient: LGT209 50 mg

Patient: LGT209 300 mg

Healthy Volunteers: LGT209 300 mg

Patient: Placebo

Healthy volunteers: Placebo

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Plasma concentrations of atorvastatin in patients
Plasma concentrations of simvastatin in patients
Serum concentrations of PCSK9

Full Information

First Posted
May 9, 2013
Last Updated
December 16, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01859455
Brief Title
Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (Actual)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, LDL Cholesterol
Keywords
Hypercholesterolemia,, LDL cholesterol lowering,, proprotein convertase subtilisin/kexin type 9 (PCSK9),, LGT209,, drug safety,, pharmacokinetics,, pharmacodynamics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient: LGT209 50 mg
Arm Type
Experimental
Arm Description
50 mg LGT209 subcutaneous (SC) (1 mL injection x 1 site) in statin patients
Arm Title
Patient: LGT209 300 mg
Arm Type
Experimental
Arm Description
300 mg LGT209 subcutaneous (SC) (1 mL injection x 2 sites) in statin patients
Arm Title
Healthy Volunteers: LGT209 300 mg
Arm Type
Experimental
Arm Description
300 mg LGT209 or placebo subcutaneous (SC) (1 mL injection x 2 sites) in healthy volunteers
Arm Title
Patient: Placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo subcutaneous (SC) of LGT209 50 mg or 300 mg in statin patients
Arm Title
Healthy volunteers: Placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo subcutaneous (SC) of LGT209 300 mg in healthy volunteers
Intervention Type
Drug
Intervention Name(s)
LGT209 50 mg
Intervention Description
Active experimental drug
Intervention Type
Drug
Intervention Name(s)
LGT209 300 mg
Intervention Description
Active experimental drug
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Intervention Type
Drug
Intervention Name(s)
Statins (atorvastatin or simvastatin)
Other Intervention Name(s)
Atorvastatin, Simvastatin
Intervention Description
Stable doses of atorvastatin or simvastatin
Primary Outcome Measure Information:
Title
Number of subjects (patients and healthy volunteers) with adverse events, serious adverse events and death
Time Frame
12 weeks
Title
Plasma concentrations of LGT209 following subcutaneous administration
Time Frame
12 weeks
Title
Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) concentration
Time Frame
baseline and 12 weeks
Title
Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Plasma concentrations of atorvastatin in patients
Time Frame
2 weeks
Title
Plasma concentrations of simvastatin in patients
Time Frame
2 weeks
Title
Serum concentrations of PCSK9
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901-8144
Country
United States
Facility Name
Novartis Investigative Site
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=8686
Description
Results for CLGT209X2105 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

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

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