HypercholesterolemiaPhase 1NCT01979601

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

A Phase 1 study testing LGT209 in people with Hypercholesterolemia, run by Novartis Pharmaceuticals at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Hypercholesterolemia
What is being tested?: LGT209
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: 2 sitesUnited States
Study dates: Dec 2010to Nov 2011
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Novartis Investigative Site
Fargo, North Dakota, 58104
Novartis Investigative Site
Miami Gardens, Florida, 33169

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenously Administered LGT209 in Healthy Volunteers and Patients With Hypercholesterolemia on Stable Doses of Statin Medications

Conditions: Hypercholesterolemia
Being tested: LGT209, Placebo
Keywords: hypercholesterolemia,, LGT209,, PCSK9,, LDL-C
Medical subject headings: Hypercholesterolemia, Hypercholesterolemia, Autosomal Dominant, 3

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LGT209Drug
150 mg lyophilized powder in glass vial
PlaceboDrug
Placebo comparator

Study groups in NCT01979601
Study group	Role	What they receive
Patient: LGT209 0.3 mg/kg	Experimental	0.3 mg/kg LGT209 intravenous administration in patients on stable doses of statins Receives: Drug: LGT209
Patient: LGT209 1 mg/kg	Experimental	1 mg/kg LGT209 intravenous administration in patients on stable doses of statins Receives: Drug: LGT209
Patient: LGT209 3 mg/kg	Experimental	3 mg/kg LGT209 intravenous administration in patients on stable doses of statins Receives: Drug: LGT209
Patient: LGT209 10 mg/kg	Experimental	10 mg/kg LGT209 intravenous administration in patients on stable doses of statins Receives: Drug: LGT209
Patient: LGT209 20 mg/kg	Experimental	20 mg/kg LGT209 intravenous administration in patients on stable doses of statins Receives: Drug: LGT209
Healthy Volunteers: LGT209 0.3 mg/kg	Experimental	0.3 mg/kg LGT209 intravenous administration in healthy volunteers Receives: Drug: LGT209
Healthy Volunteers: LGT209 1 mg/kg	Experimental	1 mg/kg LGT209 intravenous administration in healthy volunteers Receives: Drug: LGT209
Healthy Volunteers: LGT209 3 mg/kg	Experimental	3 mg/kg LGT209 intravenous administration in healthy volunteers Receives: Drug: LGT209
Healthy Volunteers: LGT209 10 mg/kg	Experimental	10 mg/kg LGT209 intravenous administration in healthy volunteers Receives: Drug: LGT209
Healthy Volunteers: 20 mg/kg	Experimental	20 mg/kg LGT209 intravenous administration in healthy volunteers Receives: Drug: LGT209
Patient: Placebo	Placebo comparator	Matching intravenous placebo in patients on stable doses of statins Receives: Drug: Placebo
Healthy Volunteers: Placebo	Placebo comparator	Matching intravenous placebo in healthy volunteers Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of patients with adverse events, serious adverse events and death
Measured: from Screening until Day 141
Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration in healthy volunteers
Baseline was defined as the arithmetic mean of all the pre-treatment values (i.e. Screening, Day -1 and predose on Day 1)
Measured: Baseline, Day 29
Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) in healthy volunteers
Baseline was defined as the arithmetic mean of all the pre-treatment values (i.e. Screening, Day -1 and predose on Day 1)
Measured: Baseline, Day 29
Pharmacokinetics of LGT209: : Area under the serum concentration-time curve from time zero to infinity (AUC0-inf) of LGT209 in patients and healthy volunteers following intravenous administration
Measured: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2); 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: observed maximum serum concentrations (Cmax) of LGT209 in patients and healthy volunteers following intravenous administration
Measured: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of LGT209 in patients and healthy volunteers following intravenous administration
Measured: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: Elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve (T1/2) of LGT209 in patients and healthy volunteers following intravenous administration
Measured: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Number of healthy volunteers with adverse events, serious adverse events and death
Measured: from Screening until Day 141

Secondary outcomes (10)

Pharmacokinetics of intravenous LGT209 in relationship to concentrations of PCSK9 and LDL-C in patients and healthy volunteers
Measured: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration in patients
Baseline was defined as the arithmetic mean of all the pre-treatment values (i.e. Screening, Day -1 and predose on Day 1)
Measured: Baseline, Day 29
Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) in patients
Baseline was defined as the arithmetic mean of all the pre-treatment values (i.e. Screening, Day -1 and predose on Day 1)
Measured: Baseline, Day 29
Pharmacokinetics of LGT209: Area under the serum concentration-time curve from time zero to time 't' (AUC0-t)
In AUC 0-t, t is a defined as time point after administration of LGT209 in patients and healthy volunteers following intravenous administration
Measured: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: Dose-normalized area under the serum concentration-time curve (AUC/D) of LGT209 in patients and healthy volunteers following intravenous administration
Measured: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: Dose-normalized maximum serum concentrations (Cmax/D) of LGT209 in patients and healthy volunteers following intravenous administration
Measured: Day 1 ( 1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: Volume of distribution during the terminal elimination phase (Vz) of LGT209 in patients and healthy volunteers following intravenous administration
Measured: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: Volume of distribution at steady state (Vss) of LGT209 in patients and healthy volunteers following intravenous administration
Measured: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: Mean residence time (MRT) of LGT209 in patients and healthy volunteers following intravenous administration
Measured: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: the systemic (or total body) clearance from serum following intravenous administration
Measured: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Nov 2011

First posted8 Nov 2013 (estimated)
Study startDec 2010
Primary completionNov 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01979601
Sponsor's protocol ID: CLGT209X2101
Status last verified: Dec 2013
First submitted: 4 Nov 2013
Last updated: 10 Dec 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenously Administered LGT209 in Healthy Volunteers and Patients With Hypercholesterolemia on Stable Doses of Statin Medications
ClinicalTrials.gov ID: NCT01979601
Acronym / sponsor ID: CLGT209X2101
Conditions: Hypercholesterolemia
Keywords: hypercholesterolemia,, LGT209,, PCSK9,, LDL-C
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 8 Nov 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 12

Arm	Type	Receives
Patient: LGT209 0.3 mg/kg	Experimental	Drug: LGT2090.3 mg/kg LGT209 intravenous administration in patients on stable doses of statins
Patient: LGT209 1 mg/kg	Experimental	Drug: LGT2091 mg/kg LGT209 intravenous administration in patients on stable doses of statins
Patient: LGT209 3 mg/kg	Experimental	Drug: LGT2093 mg/kg LGT209 intravenous administration in patients on stable doses of statins
Patient: LGT209 10 mg/kg	Experimental	Drug: LGT20910 mg/kg LGT209 intravenous administration in patients on stable doses of statins
Patient: LGT209 20 mg/kg	Experimental	Drug: LGT20920 mg/kg LGT209 intravenous administration in patients on stable doses of statins
Healthy Volunteers: LGT209 0.3 mg/kg	Experimental	Drug: LGT2090.3 mg/kg LGT209 intravenous administration in healthy volunteers
Healthy Volunteers: LGT209 1 mg/kg	Experimental	Drug: LGT2091 mg/kg LGT209 intravenous administration in healthy volunteers
Healthy Volunteers: LGT209 3 mg/kg	Experimental	Drug: LGT2093 mg/kg LGT209 intravenous administration in healthy volunteers
Healthy Volunteers: LGT209 10 mg/kg	Experimental	Drug: LGT20910 mg/kg LGT209 intravenous administration in healthy volunteers
Healthy Volunteers: 20 mg/kg	Experimental	Drug: LGT20920 mg/kg LGT209 intravenous administration in healthy volunteers
Patient: Placebo	Placebo comparator	Drug: PlaceboMatching intravenous placebo in patients on stable doses of statins
Healthy Volunteers: Placebo	Placebo comparator	Drug: PlaceboMatching intravenous placebo in healthy volunteers

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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
Other protocol-defined inclusion/exclusion criteria may apply

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LGT209150 mg lyophilized powder in glass vial	Drug	Healthy Volunteers: 20 mg/kg, Healthy Volunteers: LGT209 0.3 mg/kg, Healthy Volunteers: LGT209 1 mg/kg, Healthy Volunteers: LGT209 10 mg/kg, Healthy Volunteers: LGT209 3 mg/kg, Patient: LGT209 0.3 mg/kg, Patient: LGT209 1 mg/kg, Patient: LGT209 10 mg/kg, Patient: LGT209 20 mg/kg, Patient: LGT209 3 mg/kg
PlaceboPlacebo comparator	Drug	Healthy Volunteers: Placebo, Patient: Placebo

Primary outcome

Number of patients with adverse events, serious adverse events and death
Time frame: from Screening until Day 141
Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration in healthy volunteers
Time frame: Baseline, Day 29
Baseline was defined as the arithmetic mean of all the pre-treatment values (i.e. Screening, Day -1 and predose on Day 1)
Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) in healthy volunteers
Time frame: Baseline, Day 29
Baseline was defined as the arithmetic mean of all the pre-treatment values (i.e. Screening, Day -1 and predose on Day 1)
Pharmacokinetics of LGT209: : Area under the serum concentration-time curve from time zero to infinity (AUC0-inf) of LGT209 in patients and healthy volunteers following intravenous administration
Time frame: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2); 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: observed maximum serum concentrations (Cmax) of LGT209 in patients and healthy volunteers following intravenous administration
Time frame: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of LGT209 in patients and healthy volunteers following intravenous administration
Time frame: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: Elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve (T1/2) of LGT209 in patients and healthy volunteers following intravenous administration
Time frame: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Number of healthy volunteers with adverse events, serious adverse events and death
Time frame: from Screening until Day 141

10 secondary outcomes

Pharmacokinetics of intravenous LGT209 in relationship to concentrations of PCSK9 and LDL-C in patients and healthy volunteers
Time frame: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration in patients
Time frame: Baseline, Day 29
Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) in patients
Time frame: Baseline, Day 29
Pharmacokinetics of LGT209: Area under the serum concentration-time curve from time zero to time 't' (AUC0-t)
Time frame: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: Dose-normalized area under the serum concentration-time curve (AUC/D) of LGT209 in patients and healthy volunteers following intravenous administration
Time frame: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: Dose-normalized maximum serum concentrations (Cmax/D) of LGT209 in patients and healthy volunteers following intravenous administration
Time frame: Day 1 ( 1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: Volume of distribution during the terminal elimination phase (Vz) of LGT209 in patients and healthy volunteers following intravenous administration
Time frame: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: Volume of distribution at steady state (Vss) of LGT209 in patients and healthy volunteers following intravenous administration
Time frame: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: Mean residence time (MRT) of LGT209 in patients and healthy volunteers following intravenous administration
Time frame: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141
Pharmacokinetics of LGT209: the systemic (or total body) clearance from serum following intravenous administration
Time frame: Day 1 (1, 2, 4, 6, 8, 12 hrs post dose); Post-dose at 24 hr (Day 2) 48 hr (Day 3), 96 hr (Day 5), Days 8, 11, 15, 22, 29, 43, 57, 71, 85, 113, 141

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LGT209 in people with Hypercholesterolemia, run by Novartis Pharmaceuticals at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with adverse events, serious adverse events and death (time frame: from Screening until Day 141). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01979601.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2013.