HyperlipoproteinemiaPhase 1/2NCT01146522
Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia
A Phase 1/2 study testing LCQ908 in people with Hyperlipoproteinemia, run by Novartis Pharmaceuticals at 1 site in Canada.
Trial summary
This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperlipoproteinemia
- What is being tested?
- LCQ908
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- May 2010to Oct 2011
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hyperlipoproteinemia Type I or Type V willing and medically able to discontinue their lipid lowering medication (if prescribed).
- Non breast feeding women.
- Women of child bearing potential practicing appropriate contraception with a negative pregnancy test before dosing.
Who cannot join
- Patients with:
- uncontrolled type 1 or type 2 diabetes mellitus,
- active pancreatitis (the month prior to study start),
- history of drug or alcohol abuse within the 12 months prior to dosing,
- or any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple-dose, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCQ908 in Patients With Severe Hypertriglyceridemia and Chylomicronemia (Phenotypes I and V)
This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.
- Conditions
- Hyperlipoproteinemia
- Being tested
- LCQ908, Placebo
- Keywords
- Familial hyperchylomicronemia, Lipoprotein lipase deficiency, Hyperlipoproteinemia, Triglycerides, Hypertriglyceridemia, LCQ908, Hyperlipoproteinemia associated with lipoprotein lipase deficiency
- Medical subject headings
- Hyperlipoproteinemias, Hyperlipoproteinemia Type I, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCQ908Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| LCQ908 | Experimental | Not described Receives: Drug: LCQ908 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting and postprandial plasma triglycerides
Measured: baseline and 3 weeks after initiation of each dose level (a test meal will be served at baseline and on Day 21 of treatment)
Secondary outcomes (2)
Blood concentration to characterize LCQ908 kinetics
Measured: serial blood samples will be collected from all patients enrolled in the study on Day 21 of treatment with each dose
Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids)
Measured: after 3 weeks of treatment with each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipoproteinemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 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
- NCT01146522
- Sponsor's protocol ID
- CLCQ908A2212
- Status last verified
- Dec 2012
- First submitted
- 9 Jun 2010
- Last updated
- 17 Dec 2020
- Results posted
- No
Publications
Meyers CD, Tremblay K, Amer A, Chen J, Jiang L, Gaudet D. Effect of the DGAT1 inhibitor pradigastat on triglyceride and apoB48 levels in patients with familial chylomicronemia syndrome. Lipids Health Dis. 2015 Feb 18;14:8. doi: 10.1186/s12944-015-0006-5.
PubMed 25889044
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 Multiple-dose, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCQ908 in Patients With Severe Hypertriglyceridemia and Chylomicronemia (Phenotypes I and V)
- ClinicalTrials.gov ID
- NCT01146522
- Acronym / sponsor ID
- CLCQ908A2212
- Conditions
- Hyperlipoproteinemia
- Keywords
- Familial hyperchylomicronemia, Lipoprotein lipase deficiency, Hyperlipoproteinemia, Triglycerides, Hypertriglyceridemia, LCQ908, Hyperlipoproteinemia associated with lipoprotein lipase deficiency
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 Jun 2010 (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 will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCQ908 | Experimental | Drug: LCQ908 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with hyperlipoproteinemia Type I or Type V willing and medically able to discontinue their lipid lowering medication (if prescribed).
- Non breast feeding women.
- Women of child bearing potential practicing appropriate contraception with a negative pregnancy test before dosing.
Key exclusion criteria (6 listed)
- uncontrolled type 1 or type 2 diabetes mellitus,
- active pancreatitis (the month prior to study start),
- history of drug or alcohol abuse within the 12 months prior to dosing,
- or any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study.
- 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 |
|---|---|---|
| LCQ908 | Drug | LCQ908 |
| Placebo | Drug | Placebo |
Primary outcome
Fasting and postprandial plasma triglycerides
Time frame: baseline and 3 weeks after initiation of each dose level (a test meal will be served at baseline and on Day 21 of treatment)
2 secondary outcomes
Blood concentration to characterize LCQ908 kinetics
Time frame: serial blood samples will be collected from all patients enrolled in the study on Day 21 of treatment with each dose
Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids)
Time frame: after 3 weeks of treatment with each dose
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.
- Derived from this study: PubMed 25889044Meyers CD, Tremblay K, Amer A, Chen J, Jiang L, Gaudet D. Effect of the DGAT1 inhibitor pradigastat on triglyceride and apoB48 levels in patients with familial chylomicronemia syndrome. Lipids Health Dis. 2015 Feb 18;14:8. doi: 10.1186/s12944-015-0006-5.
- Results for CLCQ908A2212 from the Novartis Clinical Trials websiteLink provided by the sponsor.
Related trials for Hyperlipoproteinemia
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LCQ908 in people with Hyperlipoproteinemia, run by Novartis Pharmaceuticals at 1 site in Canada.
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 3 inclusion and 6 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 1 site in Canada. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Fasting and postprandial plasma triglycerides (time frame: baseline and 3 weeks after initiation of each dose level (a test meal will be served at baseline and on Day 21 of treatment)). 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 NCT01146522, which also lists 1 linked publication.
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.