Non Familial Chylocmicronemia Syndrome (Non-FCS)Phase 2NCT01594983
A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia
A Phase 2 study testing LCQ908, Fenofibrate and Fish Oil in people with Non Familial Chylocmicronemia Syndrome (Non-FCS), run by Novartis Pharmaceuticals at 32 sites in 3 countries.
Trial summary
This study is to determine a dose response signal for LCQ908 monotherapy and to assess the efficacy and safety of adding LCQ908 to Lovaza or fenofibrate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Familial Chylocmicronemia Syndrome (Non-FCS)
- What is being tested?
- LCQ908, Fenofibrate and Fish Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 32 sitesin 3 countries
- Study dates
- Jun 2012to Jul 2013
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects ages >18 years of age, inclusive.
- History of plasma TG concentration ≥890 mg/dl (10 mmol/L) or history of lactescent plasma in the fasting state.
- Fasting TG ≥ 750 mg/dL (8.5 mmol/L) at day -7 or repeat of day -7 one week later for those failing to qualify initially and thought likely to qualify on repeat examination prior to randomization.
Who cannot join
- Treatment with Omega-3 fatty acids or niacin or fibrates within 8 weeks of screening.
- Patients with confirmed Familial Chylomicronemia Syndrome (FCS) with hyperlipoproteinemia (HLP) Type-I diagnosis or known to be homozygotes or compound heterozygotes for mutations in HLP Type I-causing genes (such as LPL, apoCII, CPIHBP1, or LMF1) prior to screening.
- Pancreatitis within 3 months prior to screening.
- Uncontrolled type 2 diabetes (T2DM) (as defined by an HbA1c value of ≥8.0% at screening)
- BMI > 40 or history of bariatric surgery.
- Nephrotic syndrome, Type 1 diabetes, HIV, HCV or HBV positive.
- Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2
- Other protocol defined inclusion/exclusion criteria may apply
Trial locations and contacts
32 sites in 3 countries.
32 sites in 3 countries
United States28 sites
Novartis Investigative Site
Boerne, Texas, 78006
Novartis Investigative Site
Brandon, Florida, 33511
Novartis Investigative Site
Bristol, Tennessee, 37620
Novartis Investigative Site
Butte, Montana, 59701
Novartis Investigative Site
Cary, North Carolina, 27518
Novartis Investigative Site
Colorado Springs, Colorado, 80906
Novartis Investigative Site
Corpus Christi, Texas, 78404
Novartis Investigative Site
Encinitas, California, 92024-1332
Novartis Investigative Site
Eugene, Oregon, 97404
Novartis Investigative Site
Glendale, Arizona, 85306
Novartis Investigative Site
Houston, Texas, 77074
Novartis Investigative Site
Lansdale, Pennsylvania, 19446
Novartis Investigative Site
Louisville, Kentucky, 40213
Novartis Investigative Site
Lyndhurst, Ohio, 44124
Novartis Investigative Site
Marion, Ohio, 43302
Novartis Investigative Site
Miami, Florida, 33156
Novartis Investigative Site
Muscle Shoals, Alabama, 35662
Novartis Investigative Site
Ocala, Florida, 34471
Novartis Investigative Site
Oklahoma City, Oklahoma, 73103
Novartis Investigative Site
Oklahoma City, Oklahoma, 73112
Novartis Investigative Site
Oklahoma City, Oklahoma, 73135
Novartis Investigative Site
Orange City, Florida, 32763
Novartis Investigative Site
Orlando, Florida, 32806
Novartis Investigative Site
Oxon Hill, Maryland, 20745
Novartis Investigative Site
Port Orange, Florida, 32127
Novartis Investigative Site
Salisbury, North Carolina, 28144
Novartis Investigative Site
St. Petersburg, Florida, 33709
Novartis Investigative Site
Tulsa, Oklahoma, 74136
Canada2 sites
Novartis Investigative Site
Chicoutimi, Quebec, G7H 5H6
Novartis Investigative Site
Ste-Foy, Quebec, G1V4M6
Russia2 sites
Novartis Investigative Site
Moscow, 121552
Novartis Investigative Site
Moscow, 129090
About this study
Official title: A Multicenter, Randomized, Active Comparator, Placebo Controlled, Double-blind Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia
This study is to determine a dose response signal for LCQ908 monotherapy and to assess the efficacy and safety of adding LCQ908 to Lovaza or fenofibrate.
- Being tested
- LCQ908, Fenofibrate, Fish Oil, Placebo of LCQ908, Placebo of fenofibrate
- Keywords
- hypertriglyceridemia, Non familial Chylocmicronemia Syndrome (non-FCS)
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCQ908Drug
FenofibrateDrug
Fenofibrate once daily 12 weeks
Fish OilDrug
Also called Lovaza®
Fish Oil once daily for 12 weeks
Placebo of LCQ908Drug
Matching placebo of LCQ908
Placebo of fenofibrateDrug
Matching placebo of fenofibrate
Placebo of fish oilDrug
Matching placebo of fish oil capsule
| Study group | Role | What they receive |
|---|---|---|
| LCQ908 1 | Experimental | LCQ908 (Diacylglycerol acyltransferase inhibitor)once daily for 12 weeks Receives: Drug: LCQ908; Drug: Placebo of LCQ908; Drug: Placebo of fenofibrate; Drug: Placebo of fish oil |
| LCQ908 2 | Experimental | LCQ908 once daily for 12 weeks Receives: Drug: LCQ908; Drug: Placebo of LCQ908; Drug: Placebo of fenofibrate; Drug: Placebo of fish oil |
| LCQ908 3 | Experimental | LCQ908 once daily for 12 weeks Receives: Drug: LCQ908; Drug: Placebo of LCQ908; Drug: Placebo of fenofibrate; Drug: Placebo of fish oil |
| Fenofibrate | Active comparator | Intervention Type: Drug Intervention Name: Fenofibrate Receives: Drug: LCQ908; Drug: Fenofibrate; Drug: Placebo of LCQ908; Drug: Placebo of fish oil |
| Fish Oil | Active comparator | Fish oil once daily for 12 weeks Receives: Drug: LCQ908; Drug: Fish Oil; Drug: Placebo of LCQ908; Drug: Placebo of fenofibrate |
| Arm Label: Placebo | Placebo comparator | Intervention Type: other Intervention Name: other Receives: Drug: Placebo of LCQ908; Drug: Placebo of fenofibrate; Drug: Placebo of fish oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in triglycerides (TG) relative to placebo at 6 weeks
The dose response signal of 3 dose regiments of LCQ908 in patients at risk for non-FCS chylomicronemia as was measured by change from baseline in triglycerides (TG) relative to placebo at 6 weeks.
Measured: Baseline, 6 weeks
Secondary outcomes (5)
Change from baseline in triglycerides after adding LCQ908 to background therapy of fenofibrate or Fish Oil at 12 weeks
Measured: Baseline, 12 weeks
Changes from baseline in triglycerides after treatment with LCQ908 monotherapy relative to fenofibrate or fish oil at 6 weeks
Measured: Baseline, 6 weeks
Change from baseline in triglycerides after treatment with LCQ908 monotherapy relative to placebo at 12 weeks
Measured: Baseline, 12 weeks
Number of patients in LCQ908 monotherapy with adverse events , serious adverse events and death
Measured: 12 weeks
changefrom baseline in lipids and lipoprotein profiles
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Familial Chylocmicronemia Syndrome (Non-FCS)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 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
- NCT01594983
- Sponsor's protocol ID
- CLCQ908C2201
- Other IDs
- 2012-000872-40
- Status last verified
- Oct 2015
- First submitted
- 7 May 2012
- 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 Multicenter, Randomized, Active Comparator, Placebo Controlled, Double-blind Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT01594983
- Acronym / sponsor ID
- CLCQ908C2201
- Keywords
- hypertriglyceridemia, Non familial Chylocmicronemia Syndrome (non-FCS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 9 May 2012 (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 to determine a dose response signal for LCQ908 monotherapy and to assess the efficacy and safety of adding LCQ908 to Lovaza or fenofibrate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LCQ908 1 | Experimental | Drug: LCQ908, Drug: Placebo of LCQ908, Drug: Placebo of fenofibrate, Drug: Placebo of fish oilLCQ908 (Diacylglycerol acyltransferase inhibitor)once daily for 12 weeks |
| LCQ908 2 | Experimental | Drug: LCQ908, Drug: Placebo of LCQ908, Drug: Placebo of fenofibrate, Drug: Placebo of fish oilLCQ908 once daily for 12 weeks |
| LCQ908 3 | Experimental | Drug: LCQ908, Drug: Placebo of LCQ908, Drug: Placebo of fenofibrate, Drug: Placebo of fish oilLCQ908 once daily for 12 weeks |
| Fenofibrate | Active comparator | Drug: LCQ908, Drug: Fenofibrate, Drug: Placebo of LCQ908, Drug: Placebo of fish oilIntervention Type: Drug Intervention Name: Fenofibrate |
| Fish Oil | Active comparator | Drug: LCQ908, Drug: Fish Oil, Drug: Placebo of LCQ908, Drug: Placebo of fenofibrateFish oil once daily for 12 weeks |
| Arm Label: Placebo | Placebo comparator | Drug: Placebo of LCQ908, Drug: Placebo of fenofibrate, Drug: Placebo of fish oilIntervention Type: other Intervention Name: other |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects ages >18 years of age, inclusive.
- History of plasma TG concentration ≥890 mg/dl (10 mmol/L) or history of lactescent plasma in the fasting state.
- Fasting TG ≥ 750 mg/dL (8.5 mmol/L) at day -7 or repeat of day -7 one week later for those failing to qualify initially and thought likely to qualify on repeat examination prior to randomization.
Key exclusion criteria (8 listed)
- Treatment with Omega-3 fatty acids or niacin or fibrates within 8 weeks of screening.
- Patients with confirmed Familial Chylomicronemia Syndrome (FCS) with hyperlipoproteinemia (HLP) Type-I diagnosis or known to be homozygotes or compound heterozygotes for mutations in HLP Type I-causing genes (such as LPL, apoCII, CPIHBP1, or LMF1) prior to screening.
- Pancreatitis within 3 months prior to screening.
- Uncontrolled type 2 diabetes (T2DM) (as defined by an HbA1c value of ≥8.0% at screening)
- BMI > 40 or history of bariatric surgery.
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 | Fenofibrate, Fish Oil, LCQ908 1, LCQ908 2, LCQ908 3 |
| FenofibrateFenofibrate once daily 12 weeks | Drug | Fenofibrate |
| Fish OilAlso: Lovaza®Fish Oil once daily for 12 weeks | Drug | Fish Oil |
| Placebo of LCQ908Matching placebo of LCQ908 | Drug | Arm Label: Placebo, Fenofibrate, Fish Oil, LCQ908 1, LCQ908 2, LCQ908 3 |
| Placebo of fenofibrateMatching placebo of fenofibrate | Drug | Arm Label: Placebo, Fish Oil, LCQ908 1, LCQ908 2, LCQ908 3 |
| Placebo of fish oilMatching placebo of fish oil capsule | Drug | Arm Label: Placebo, Fenofibrate, LCQ908 1, LCQ908 2, LCQ908 3 |
Primary outcome
Change from baseline in triglycerides (TG) relative to placebo at 6 weeks
Time frame: Baseline, 6 weeks
The dose response signal of 3 dose regiments of LCQ908 in patients at risk for non-FCS chylomicronemia as was measured by change from baseline in triglycerides (TG) relative to placebo at 6 weeks.
5 secondary outcomes
Change from baseline in triglycerides after adding LCQ908 to background therapy of fenofibrate or Fish Oil at 12 weeks
Time frame: Baseline, 12 weeks
Changes from baseline in triglycerides after treatment with LCQ908 monotherapy relative to fenofibrate or fish oil at 6 weeks
Time frame: Baseline, 6 weeks
Change from baseline in triglycerides after treatment with LCQ908 monotherapy relative to placebo at 12 weeks
Time frame: Baseline, 12 weeks
Number of patients in LCQ908 monotherapy with adverse events , serious adverse events and death
Time frame: 12 weeks
changefrom baseline in lipids and lipoprotein profiles
Time frame: Baseline, 6 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 CLCQ908C2201 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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
32 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LCQ908, Fenofibrate and Fish Oil in people with Non Familial Chylocmicronemia Syndrome (Non-FCS), run by Novartis Pharmaceuticals at 32 sites in 3 countries.
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 8 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 32 sites in United States, Canada, Russia. 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 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?
Change from baseline in triglycerides (TG) relative to placebo at 6 weeks (time frame: Baseline, 6 weeks). 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.