A 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 Identifier: NCT01594983
• Recruitment Status: Completed
• First Posted: May 9, 2012
• Last Update Posted: December 17, 2020
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Non Familial Chylocmicronemia Syndrome (Non-FCS)	Drug: LCQ908; Drug: Fenofibrate; Drug: Fish Oil; Drug: Placebo of LCQ908; Drug: Placebo of fenofibrate; Drug: Placebo of fish oil	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: June 2012
• Actual Primary Completion Date: July 2013
• Actual Study Completion Date: July 2013

Arms and Interventions

Arm	Intervention/treatment
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: Fenofibrate; Fenofibrate once daily 12 weeks; Drug: Placebo of LCQ908; Matching placebo of LCQ908; Drug: Placebo of fish oil; Matching placebo of fish oil capsule
Active Comparator: Fish Oil; Fish oil once daily for 12 weeks	Drug: LCQ908; Drug: Fish Oil; Fish Oil once daily for 12 weeks; Other Name: Lovaza®; Drug: Placebo of LCQ908; Matching placebo of LCQ908; Drug: Placebo of fenofibrate; Matching placebo of fenofibrate
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Change from baseline in triglycerides after adding LCQ908 to background therapy of fenofibrate or Fish Oil at 12 weeks [ Time Frame: Baseline, 12 weeks ]
2. Changes from baseline in triglycerides after treatment with LCQ908 monotherapy relative to fenofibrate or fish oil at 6 weeks [ Time Frame: Baseline, 6 weeks ]
3. Change from baseline in triglycerides after treatment with LCQ908 monotherapy relative to placebo at 12 weeks [ Time Frame: Baseline, 12 weeks ]
4. Number of patients in LCQ908 monotherapy with adverse events , serious adverse events and death [ Time Frame: 12 weeks ]
5. changefrom baseline in lipids and lipoprotein profiles [ Time Frame: Baseline, 6 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Alabama

Novartis Investigative Site

Muscle Shoals, Alabama, United States, 35662

United States, Arizona

Novartis Investigative Site

Glendale, Arizona, United States, 85306

United States, California

Novartis Investigative Site

Encinitas, California, United States, 92024-1332

United States, Colorado

Novartis Investigative Site

Colorado Springs, Colorado, United States, 80906

United States, Florida

Novartis Investigative Site

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

United States, Kentucky

Novartis Investigative Site

Louisville, Kentucky, United States, 40213

United States, Maryland

Novartis Investigative Site

Oxon Hill, Maryland, United States, 20745

United States, Montana

Novartis Investigative Site

Butte, Montana, United States, 59701

United States, North Carolina

Novartis Investigative Site

Cary, North Carolina, United States, 27518

Novartis Investigative Site

Salisbury, North Carolina, United States, 28144

United States, Ohio

Novartis Investigative Site

Lyndhurst, Ohio, United States, 44124

Novartis Investigative Site

Marion, Ohio, United States, 43302

United States, Oklahoma

Novartis Investigative Site

Oklahoma City, Oklahoma, United States, 73103

Novartis Investigative Site

Oklahoma City, Oklahoma, United States, 73112

Novartis Investigative Site

Oklahoma City, Oklahoma, United States, 73135

Novartis Investigative Site

Tulsa, Oklahoma, United States, 74136

United States, Oregon

Novartis Investigative Site

Eugene, Oregon, United States, 97404

United States, Pennsylvania

Novartis Investigative Site

Lansdale, Pennsylvania, United States, 19446

United States, Tennessee

Novartis Investigative Site

Bristol, Tennessee, United States, 37620

United States, Texas

Novartis Investigative Site

Boerne, Texas, United States, 78006

Novartis Investigative Site

Corpus Christi, Texas, United States, 78404

Novartis Investigative Site

Houston, Texas, United States, 77074

Canada, Quebec

Novartis Investigative Site

Chicoutimi, Quebec, Canada, G7H 5H6

Novartis Investigative Site

Ste-Foy, Quebec, Canada, G1V4M6

Russian Federation

Novartis Investigative Site

Moscow, Russian Federation, 121552

Novartis Investigative Site

Moscow, Russian Federation, 129090

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

Additional Information:

Results for CLCQ908C2201 from the Novartis Clinical Trials website 

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01594983
• Other Study ID Numbers: CLCQ908C2201; 2012-000872-40 ( EudraCT Number )
• First Posted: May 9, 2012
• Last Update Posted: December 17, 2020
• Last Verified: October 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

hypertriglyceridemia; Non familial Chylocmicronemia Syndrome (non-FCS)

Additional relevant MeSH terms:

Hypertriglyceridemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Fenofibrate; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents