A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia

December 11, 2020 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Novartis Investigative Site
      • Ste-Foy, Quebec, Canada, G1V4M6
        • Novartis Investigative Site
  • Russian Federation
      • Moscow, Russian Federation, 121552
        • Novartis Investigative Site
      • Moscow, Russian Federation, 129090
        • Novartis Investigative Site
  • United States
    • Alabama
      • Muscle Shoals, Alabama, United States, 35662
        • Novartis Investigative Site
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Novartis Investigative Site
    • California
      • Encinitas, California, United States, 92024-1332
        • Novartis Investigative Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80906
        • Novartis Investigative Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Novartis Investigative Site
      • Miami, Florida, United States, 33156
        • Novartis Investigative Site
      • Ocala, Florida, United States, 34471
        • Novartis Investigative Site
      • Orange City, Florida, United States, 32763
        • Novartis Investigative Site
      • Orlando, Florida, United States, 32806
        • Novartis Investigative Site
      • Port Orange, Florida, United States, 32127
        • Novartis Investigative Site
      • Saint Petersburg, Florida, United States, 33709
        • Novartis Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Novartis Investigative Site
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
        • Novartis Investigative Site
    • Montana
      • Butte, Montana, United States, 59701
        • Novartis Investigative Site
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Novartis Investigative Site
      • Salisbury, North Carolina, United States, 28144
        • Novartis Investigative Site
    • Ohio
      • Lyndhurst, Ohio, United States, 44124
        • Novartis Investigative Site
      • Marion, Ohio, United States, 43302
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Novartis Investigative Site
      • Oklahoma City, Oklahoma, United States, 73103
        • Novartis Investigative Site
      • Oklahoma City, Oklahoma, United States, 73135
        • Novartis Investigative Site
      • Tulsa, Oklahoma, United States, 74136
        • Novartis Investigative Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Novartis Investigative Site
    • Pennsylvania
      • Lansdale, Pennsylvania, United States, 19446
        • Novartis Investigative Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Novartis Investigative Site
    • Texas
      • Boerne, Texas, United States, 78006
        • Novartis Investigative Site
      • Corpus Christi, Texas, United States, 78404
        • Novartis Investigative Site
      • Houston, Texas, United States, 77074
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LCQ908 1
LCQ908 (Diacylglycerol acyltransferase inhibitor)once daily for 12 weeks
Drug: LCQ908
Drug: Placebo of LCQ908
Matching placebo of LCQ908
Drug: Placebo of fenofibrate
Matching placebo of fenofibrate
Drug: Placebo of fish oil
Matching placebo of fish oil capsule
Experimental: LCQ908 2
LCQ908 once daily for 12 weeks
Drug: LCQ908
Drug: Placebo of LCQ908
Matching placebo of LCQ908
Drug: Placebo of fenofibrate
Matching placebo of fenofibrate
Drug: Placebo of fish oil
Matching placebo of fish oil capsule
Experimental: LCQ908 3
LCQ908 once daily for 12 weeks
Drug: LCQ908
Drug: Placebo of LCQ908
Matching placebo of LCQ908
Drug: Placebo of fenofibrate
Matching placebo of fenofibrate
Drug: Placebo of fish oil
Matching placebo of fish oil capsule
Active Comparator: Fenofibrate
Intervention Type: Drug Intervention Name: Fenofibrate
Drug: LCQ908
Drug: Placebo of LCQ908
Matching placebo of LCQ908
Drug: Placebo of fish oil
Matching placebo of fish oil capsule
Drug: Fenofibrate
Fenofibrate once daily 12 weeks
Active Comparator: Fish Oil
Fish oil once daily for 12 weeks
Drug: LCQ908
Drug: Placebo of LCQ908
Matching placebo of LCQ908
Drug: Placebo of fenofibrate
Matching placebo of fenofibrate
Drug: Fish Oil
Fish Oil once daily for 12 weeks
Other Names:
  • Lovaza®
Placebo Comparator: Arm Label: Placebo
Intervention Type: other Intervention Name: other
Drug: Placebo of LCQ908
Matching placebo of LCQ908
Drug: Placebo of fenofibrate
Matching placebo of fenofibrate
Drug: Placebo of fish oil
Matching placebo of fish oil capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in triglycerides after adding LCQ908 to background therapy of fenofibrate or Fish Oil at 12 weeks
Time Frame: Baseline, 12 weeks
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
Baseline, 6 weeks
Change from baseline in triglycerides after treatment with LCQ908 monotherapy relative to placebo at 12 weeks
Time Frame: Baseline, 12 weeks
Baseline, 12 weeks
Number of patients in LCQ908 monotherapy with adverse events , serious adverse events and death
Time Frame: 12 weeks
12 weeks
changefrom baseline in lipids and lipoprotein profiles
Time Frame: Baseline, 6 weeks
Baseline, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLCQ908C2201
  • 2012-000872-40 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings