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

NCT01594983 | Completed Phase 2

• 2 other identifiers: CLCQ908C22012012-000872-40
• Study Type: interventional
• Target: 58
• Locations: 3 countries
• Sites: 32

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.

Conditions

Non Familial Chylocmicronemia Syndrome (Non-FCS)

Keywords

hypertriglyceridemia; Non familial Chylocmicronemia Syndrome (non-FCS)

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline, 12 weeks

• Changes from baseline in triglycerides after treatment with LCQ908 monotherapy relative to fenofibrate or fish oil at 6 weeks

  Baseline, 6 weeks

• Change from baseline in triglycerides after treatment with LCQ908 monotherapy relative to placebo at 12 weeks

  Baseline, 12 weeks

• Number of patients in LCQ908 monotherapy with adverse events , serious adverse events and death

  12 weeks

• changefrom baseline in lipids and lipoprotein profiles

  Baseline, 6 weeks

Study Arms (6)

LCQ908 1

EXPERIMENTAL

LCQ908 (Diacylglycerol acyltransferase inhibitor)once daily for 12 weeks

Drug: LCQ908; Drug: Placebo of LCQ908; Drug: Placebo of fenofibrate; Drug: Placebo of fish oil

LCQ908 2

EXPERIMENTAL

LCQ908 once daily for 12 weeks

Drug: LCQ908; Drug: Placebo of LCQ908; Drug: Placebo of fenofibrate; Drug: Placebo of fish oil

LCQ908 3

EXPERIMENTAL

LCQ908 once daily for 12 weeks

Drug: LCQ908; Drug: Placebo of LCQ908; Drug: Placebo of fenofibrate; Drug: Placebo of fish oil

Fenofibrate

ACTIVE COMPARATOR

Intervention Type: Drug Intervention Name: Fenofibrate

Drug: LCQ908; Drug: Fenofibrate; Drug: Placebo of LCQ908; Drug: Placebo of fish oil

Fish Oil

ACTIVE COMPARATOR

Fish oil once daily for 12 weeks

Drug: LCQ908; Drug: Fish Oil; Drug: Placebo of LCQ908; Drug: Placebo of fenofibrate

Arm Label: Placebo

PLACEBO COMPARATOR

Intervention Type: other Intervention Name: other

Drug: Placebo of LCQ908; Drug: Placebo of fenofibrate; Drug: Placebo of fish oil

Interventions

LCQ908 DRUG

Fenofibrate; Fish Oil; LCQ908 1; LCQ908 2; LCQ908 3

Fenofibrate DRUG

Fenofibrate once daily 12 weeks

Fenofibrate

Fish Oil DRUG

Fish Oil once daily for 12 weeks

Also known as: Lovaza®

Fish Oil

Placebo of LCQ908 DRUG

Matching placebo of LCQ908

Arm Label: Placebo; Fenofibrate; Fish Oil; LCQ908 1; LCQ908 2; LCQ908 3

Placebo of fenofibrate DRUG

Matching placebo of fenofibrate

Arm Label: Placebo; Fish Oil; LCQ908 1; LCQ908 2; LCQ908 3

Placebo of fish oil DRUG

Matching placebo of fish oil capsule

Arm Label: Placebo; Fenofibrate; LCQ908 1; LCQ908 2; LCQ908 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (32)

Novartis Investigative Site

Muscle Shoals, Alabama, 35662, United States

Location

Novartis Investigative Site

Glendale, Arizona, 85306, United States

Location

Novartis Investigative Site

Encinitas, California, 92024-1332, United States

Location

Novartis Investigative Site

Colorado Springs, Colorado, 80906, United States

Location

Novartis Investigative Site

Brandon, Florida, 33511, United States

Location

Novartis Investigative Site

Miami, Florida, 33156, United States

Location

Novartis Investigative Site

Ocala, Florida, 34471, United States

Location

Novartis Investigative Site

Orange City, Florida, 32763, United States

Location

Novartis Investigative Site

Orlando, Florida, 32806, United States

Location

Novartis Investigative Site

Port Orange, Florida, 32127, United States

Location

Novartis Investigative Site

St. Petersburg, Florida, 33709, United States

Location

Novartis Investigative Site

Louisville, Kentucky, 40213, United States

Location

Novartis Investigative Site

Oxon Hill, Maryland, 20745, United States

Location

Novartis Investigative Site

Butte, Montana, 59701, United States

Location

Novartis Investigative Site

Cary, North Carolina, 27518, United States

Location

Novartis Investigative Site

Salisbury, North Carolina, 28144, United States

Location

Novartis Investigative Site

Lyndhurst, Ohio, 44124, United States

Location

Novartis Investigative Site

Marion, Ohio, 43302, United States

Location

Novartis Investigative Site

Oklahoma City, Oklahoma, 73103, United States

Location

Novartis Investigative Site

Oklahoma City, Oklahoma, 73112, United States

Location

Novartis Investigative Site

Oklahoma City, Oklahoma, 73135, United States

Location

Novartis Investigative Site

Tulsa, Oklahoma, 74136, United States

Location

Novartis Investigative Site

Eugene, Oregon, 97404, United States

Location

Novartis Investigative Site

Lansdale, Pennsylvania, 19446, United States

Location

Novartis Investigative Site

Bristol, Tennessee, 37620, United States

Location

Novartis Investigative Site

Boerne, Texas, 78006, United States

Location

Novartis Investigative Site

Corpus Christi, Texas, 78404, United States

Location

Novartis Investigative Site

Houston, Texas, 77074, United States

Location

Novartis Investigative Site

Chicoutimi, Quebec, G7H 5H6, Canada

Location

Novartis Investigative Site

Ste-Foy, Quebec, G1V4M6, Canada

Location

Novartis Investigative Site

Moscow, 121552, Russia

Location

Novartis Investigative Site

Moscow, 129090, Russia

Location

Related Links

• Results for CLCQ908C2201 from the Novartis Clinical Trials website

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

pradigastat; Fenofibrate; Fish Oils; Omacor

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Oils; Lipids

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 9, 2012
• Study Start: June 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 17, 2020

Record last verified: 2015-10

Locations

RU (2); US (28); CA (2)