MedDataX Logo

Safety, Tolerability, PK and PD of LGT209 in Healthy Volunteers and Patients With Hypercholesterolemia

NCT ID: NCT01979601

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to measure the effects of LGT209 when given intravenously to patients with high cholesterol who are on stable doses of statin medications, and to healthy subjects with elevated cholesterol

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercholesterolemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hypercholesterolemia, LGT209, PCSK9, LDL-C

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient: LGT209 0.3 mg/kg

0.3 mg/kg LGT209 intravenous administration in patients on stable doses of statins

Group Type EXPERIMENTAL

LGT209

Intervention Type DRUG

150 mg lyophilized powder in glass vial

Patient: LGT209 1 mg/kg

1 mg/kg LGT209 intravenous administration in patients on stable doses of statins

Group Type EXPERIMENTAL

LGT209

Intervention Type DRUG

150 mg lyophilized powder in glass vial

Patient: LGT209 3 mg/kg

3 mg/kg LGT209 intravenous administration in patients on stable doses of statins

Group Type EXPERIMENTAL

LGT209

Intervention Type DRUG

150 mg lyophilized powder in glass vial

Patient: LGT209 10 mg/kg

10 mg/kg LGT209 intravenous administration in patients on stable doses of statins

Group Type EXPERIMENTAL

LGT209

Intervention Type DRUG

150 mg lyophilized powder in glass vial

Patient: LGT209 20 mg/kg

20 mg/kg LGT209 intravenous administration in patients on stable doses of statins

Group Type EXPERIMENTAL

LGT209

Intervention Type DRUG

150 mg lyophilized powder in glass vial

Healthy Volunteers: LGT209 0.3 mg/kg

0.3 mg/kg LGT209 intravenous administration in healthy volunteers

Group Type EXPERIMENTAL

LGT209

Intervention Type DRUG

150 mg lyophilized powder in glass vial

Healthy Volunteers: LGT209 1 mg/kg

1 mg/kg LGT209 intravenous administration in healthy volunteers

Group Type EXPERIMENTAL

LGT209

Intervention Type DRUG

150 mg lyophilized powder in glass vial

Healthy Volunteers: LGT209 3 mg/kg

3 mg/kg LGT209 intravenous administration in healthy volunteers

Group Type EXPERIMENTAL

LGT209

Intervention Type DRUG

150 mg lyophilized powder in glass vial

Healthy Volunteers: LGT209 10 mg/kg

10 mg/kg LGT209 intravenous administration in healthy volunteers

Group Type EXPERIMENTAL

LGT209

Intervention Type DRUG

150 mg lyophilized powder in glass vial

Healthy Volunteers: 20 mg/kg

20 mg/kg LGT209 intravenous administration in healthy volunteers

Group Type EXPERIMENTAL

LGT209

Intervention Type DRUG

150 mg lyophilized powder in glass vial

Patient: Placebo

Matching intravenous placebo in patients on stable doses of statins

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo comparator

Healthy Volunteers: Placebo

Matching intravenous placebo in healthy volunteers

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo comparator

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LGT209

150 mg lyophilized powder in glass vial

Intervention Type DRUG

Placebo

Placebo comparator

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy volunteers: Male and female subjects 18 to 70 years of age, in general good health but with high cholesterol
* Statin patients: Male and female patients 18 to 70 years of age, with high cholesterol on stable statin therapy for at least 3 months

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
* Statin patients: Use of any prescription drugs for lipid lowering other than HMG CO-A reductase inhibitors (statins); use of two concurrent antihypertensive medications is allowed, provided stable dosing has been achieved for the prior 3 months
* Women of child-bearing potential unless using highly effective methods of contraception
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Miami Gardens, Florida, United States

Site Status

Novartis Investigative Site

Fargo, North Dakota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLGT209X2101

Identifier Type: -

Identifier Source: org_study_id