HypercholesterolemiaPhase 1NCT01859455
Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins
A Phase 1 study testing LGT209 50 mg, LGT209 300 mg and Statins (atorvastatin or simvastatin) in people with Hypercholesterolemia and LDL Cholesterol, run by Novartis Pharmaceuticals at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, LDL Cholesterol
- What is being tested?
- LGT209 50 mg, LGT209 300 mg and Statins (atorvastatin or simvastatin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2011to Jul 2012
- 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 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
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
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Novartis Investigative Site
Fort Myers, Florida, 33901-8144
Novartis Investigative Site
Miramar, Florida, 33025
About this study
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
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
- Being tested
- LGT209 50 mg, LGT209 300 mg, Placebo, Statins (atorvastatin or simvastatin)
- Keywords
- Hypercholesterolemia,, LDL cholesterol lowering,, proprotein convertase subtilisin/kexin type 9 (PCSK9),, LGT209,, drug safety,, pharmacokinetics,, pharmacodynamics
- 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.
LGT209 50 mgDrug
Active experimental drug
LGT209 300 mgDrug
Active experimental drug
PlaceboDrug
Placebo comparator
Statins (atorvastatin or simvastatin)Drug
Also called Atorvastatin, Simvastatin
Stable doses of atorvastatin or simvastatin
| Study group | Role | What they receive |
|---|---|---|
| Patient: LGT209 50 mg | Experimental | 50 mg LGT209 subcutaneous (SC) (1 mL injection x 1 site) in statin patients Receives: 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 Receives: 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 Receives: Drug: LGT209 300 mg |
| Patient: Placebo | Placebo comparator | matching placebo subcutaneous (SC) of LGT209 50 mg or 300 mg in statin patients Receives: Drug: Placebo; Drug: Statins (atorvastatin or simvastatin) |
| Healthy volunteers: Placebo | Placebo comparator | matching placebo subcutaneous (SC) of LGT209 300 mg 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 subjects (patients and healthy volunteers) with adverse events, serious adverse events and death
Measured: 12 weeks
Plasma concentrations of LGT209 following subcutaneous administration
Measured: 12 weeks
Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) concentration
Measured: baseline and 12 weeks
Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration
Measured: baseline and 12 weeks
Secondary outcomes (3)
Plasma concentrations of atorvastatin in patients
Measured: 2 weeks
Plasma concentrations of simvastatin in patients
Measured: 2 weeks
Serum concentrations of PCSK9
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionJul 2012
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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859455
- Sponsor's protocol ID
- CLGT209X2105
- Status last verified
- Mar 2017
- First submitted
- 9 May 2013
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01859455
- Acronym / sponsor ID
- CLGT209X2105
- Conditions
- Hypercholesterolemia, LDL Cholesterol
- Keywords
- Hypercholesterolemia,, LDL cholesterol lowering,, proprotein convertase subtilisin/kexin type 9 (PCSK9),, LGT209,, drug safety,, pharmacokinetics,, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2011 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 May 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patient: LGT209 50 mg | Experimental | Drug: LGT209 50 mg, Drug: Statins (atorvastatin or simvastatin)50 mg LGT209 subcutaneous (SC) (1 mL injection x 1 site) in statin patients |
| Patient: LGT209 300 mg | Experimental | Drug: LGT209 300 mg, Drug: Statins (atorvastatin or simvastatin)300 mg LGT209 subcutaneous (SC) (1 mL injection x 2 sites) in statin patients |
| Healthy Volunteers: LGT209 300 mg | Experimental | Drug: LGT209 300 mg300 mg LGT209 or placebo subcutaneous (SC) (1 mL injection x 2 sites) in healthy volunteers |
| Patient: Placebo | Placebo comparator | Drug: Placebo, Drug: Statins (atorvastatin or simvastatin)matching placebo subcutaneous (SC) of LGT209 50 mg or 300 mg in statin patients |
| Healthy volunteers: Placebo | Placebo comparator | Drug: Placebomatching placebo subcutaneous (SC) of LGT209 300 mg 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 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
Key exclusion criteria (9 listed)
- 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
- 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
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 |
|---|---|---|
| LGT209 50 mgActive experimental drug | Drug | Patient: LGT209 50 mg |
| LGT209 300 mgActive experimental drug | Drug | Healthy Volunteers: LGT209 300 mg, Patient: LGT209 300 mg |
| PlaceboPlacebo comparator | Drug | Healthy volunteers: Placebo, Patient: Placebo |
| Statins (atorvastatin or simvastatin)Also: Atorvastatin, SimvastatinStable doses of atorvastatin or simvastatin | Drug | Patient: LGT209 300 mg, Patient: LGT209 50 mg, Patient: Placebo |
Primary outcome
Number of subjects (patients and healthy volunteers) with adverse events, serious adverse events and death
Time frame: 12 weeks
Plasma concentrations of LGT209 following subcutaneous administration
Time frame: 12 weeks
Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) concentration
Time frame: baseline and 12 weeks
Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration
Time frame: baseline and 12 weeks
3 secondary outcomes
Plasma concentrations of atorvastatin in patients
Time frame: 2 weeks
Plasma concentrations of simvastatin in patients
Time frame: 2 weeks
Serum concentrations of PCSK9
Time frame: 12 weeks
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 17 Dec 2020.
- Results for CLGT209X2105 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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 50 mg, LGT209 300 mg and Statins (atorvastatin or simvastatin) in people with Hypercholesterolemia and LDL Cholesterol, 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 9 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 17 Dec 2020. 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 subjects (patients and healthy volunteers) with adverse events, serious adverse events and death (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2020.