A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia

Severe Hypertriglyceridemia Clinical Trial

— INDIGO-1  

Official title:

A 12-Week, Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia (INDIGO-1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02944383
• Other study ID #: GEM-401
• Status: Completed
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: May 9, 2018

Study information

• Verified date: June 2020
• Source: NeuroBo Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A 12-Week, Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects with Severe Hypertriglyceridemia (INDIGO-1)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: May 9, 2018
• Est. primary completion date: January 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects who meet all of the following criteria will be eligible to participate in the study:

1. Provision of written and signed informed consent (by subject or legal guardian) prior to any study-specific procedure;

2. Male or female (neither pregnant or lactating) =18 years of age at time of consent;

1. Women of child-bearing potential must have a negative serum pregnancy test at the Screening Visit and negative urine dipstick on Study Day 1 prior to dosing in order to qualify for the study. Women who are surgically sterile or are clinically confirmed to be post-menopausal (i.e., documented amenorrhea for = 1 year in the absence of other biological or physiological causes) are not considered to be of child-bearing potential;

2. Women of child-bearing potential must agree to use acceptable methods of contraception throughout the duration of the study and for 30 days after the last dose of study drug. For this study, double-barrier contraception is required.

3. Currently on a self-reported, stable, low-fat, low-cholesterol diet in combination with stable statins with or without ezetimibe (10 mg QD) for at least 12 weeks prior to the Screening Visit;

4. Mean fasting TG value = 500 mg/dL to < 1500 mg/dL (with the higher value no more than 50% greater than the lower value) from the S1 and S2 Visits (or alternatively S2 and S3);

5. Physical examination, including vital signs, that is within normal limits or clinically acceptable to the Investigator;

6. Weight = 50 kg; with a body mass index (BMI) = 45 kg/m²; and

7. Subjects with Type 2 diabetes who take anti-diabetes pharmacologic therapy must be on a stable a regimen for at least 3 months, with no planned changes in medications for the study duration.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from participation in the study:

1. Known and previously documented homozygous genetic deficiencies (LPL, ApoC-II, ApoC-III, ApoA-V, GPIHBP1, or LMF1);

2. History of pancreatitis within the last 6 months prior to screening (Visit S1);

3. History of bariatric surgery; symptomatic gallstone disease, unless treated with cholecystectomy;

4. Abnormal liver function test at the Pre-Screening Visit or any of the Screening Visits (aspartate aminotransferase or alanine aminotransferase > 2 × the upper limit of normal [ULN], total bilirubin > 1.5 × ULN, or alkaline phosphatase > 2 × ULN based on appropriate age and gender normal values). Subjects with bilirubin > 1.5 × ULN and history of Gilbert's syndrome may be included; reflexive direct bilirubin testing will be used to confirm Gilbert's syndrome;

5. Active liver disease (e.g., cirrhosis, alcoholic liver disease, hepatitis B [HBV], hepatitis C [HCV], autoimmune hepatitis, liver failure, liver cancer), history of liver transplant, known diagnosis of human immunodeficiency virus (HIV), or acquired immune deficiency virus;

6. Moderate to severe renal insufficiency defined as an estimated GFR < 60 mL/min/1.73 m2 (calculated using The Chronic Kidney Disease Epidemiology Collaboration equation) at the Pre-Screening Visit or at any of the Screening Visits;

7. Abnormal urinalysis (proteinuria greater than trace or any male or non-menstruating female with greater than trace hematuria), confirmed by reflexive urine protein:creatinine ratio testing;

8. Uncontrolled thyroid disease: hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) below the lower limit of normal or > 1.5 × ULN, respectively, based on results from the Pre-Screening Visit or the Screening Visit. If controlled, treatment should be stable for at least 3 months prior to the Screening Visit;

9. Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus HbA1c value =8.5% based on results from the Pre-Screening Visit or the Screening Visit), or any diabetic subject taking a thiazolidinedione (e.g., pioglitazone, rosiglitazone);

10. New York Heart Association Class III or IV heart failure (see Appendix C);

11. Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or other major cardiovascular events resulting in hospitalization within 3 months of the Screening Visit (S1). Subjects with adequately treated stable angina, per Investigator assessment, may be included;

12. Uncontrolled cardiac arrhythmia or prolonged QT on the Screening Visit or Study Day 1 prior to dosing ECG (QTcF > 450 msec for men and >470 msec for women) or known family history of prolonged QT or unexplained sudden cardiac death;

13. Uncontrolled hypertension, defined as sitting systolic blood pressure = 180 mmHg or diastolic blood pressure = 110 mmHg, and confirmed by repeat measurement;

14. Currently receiving cancer treatment(s) or, in the Investigator's opinion, at risk of relapse for recent cancer;

15. Inadequate washout of a PCSK9 inhibitor (8 weeks prior to the Screening Visit S1), a fibrate lipid lowering agent (6 weeks prior to the Screening Visit S1), niacin > 200 mg/day, OMG-3, bile acid sequestrants or other lipid lowering therapies (4 weeks prior to the Screening Visit S1);

16. Use of any excluded medications or supplements within 3 months prior to S1 (e.g., potent cytochrome P450 [CYP] 3A4 inhibitors, see Appendix D);

17. Hypersensitivity to or a history of significant adverse reactions to any fibrate lipid regulating agent;

18. History of drug or alcohol abuse within the past year or inability to comply with protocol requirements, including subject alcohol restrictions (see Section 5.6.3);

19. Previously treated with gemcabene (i.e., CI-1027); participation in another clinical study of an investigational agent or device concurrently or within 1 month prior to the Screening Visit, or use of an investigational agent within 1 month or 5 half-lives (if known), whichever is longer, prior to the Screening Visit; or

20. Any other finding which, in the opinion of the Investigator, would compromise the subject's safety or participation in the study.

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertriglyceridemia
• Mixed Dyslipidaemia
• Severe Hypertriglyceridemia

Intervention

Drug:
• Gemcabene
Gemcabene tablets administered orally once daily, for 12 weeks.
• Placebo
Placebo tablets administered orally once daily, for 12 weeks.

Locations

Country	Name	City	State
Canada	Ecogene-21	Chicoutimi	Quebec
United States	University of Michigan Health Systems	Ann Arbor	Michigan
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Eastern Carolina Medical Clinic	Benson	North Carolina
United States	Westside Medical Associates of Los Angeles	Beverly Hills	California
United States	Excel Medical Research	Boca Raton	Florida
United States	Meridien Research	Bradenton	Florida
United States	Advantage Clinical Trials	Bronx	New York
United States	CHEAR Center, LLC	Bronx	New York
United States	Hope Clinical Research	Canoga Park	California
United States	Optimed Research	Columbus	Ohio
United States	Clinical Trials Management, LLC	Covington	Louisiana
United States	PriMed Clinical Research	Dayton	Ohio
United States	Evanston Premier Clinical Research	Evanston	Illinois
United States	Physicians East, NA	Farmville	North Carolina
United States	Appalachian Research Associates	Fort Payne	Alabama
United States	SC Clinical Research	Garden Grove	California
United States	Physicians East, NA	Greenville	North Carolina
United States	Direct Helpers Research Center	Hialeah	Florida
United States	Indago Research and Health Center	Hialeah	Florida
United States	Airline Complete Healthcare	Houston	Texas
United States	National Research Institute	Huntington Park	California
United States	Midwest Institute for Clinical Research, Inc.	Indianapolis	Indiana
United States	Elite Clinical Research	Jackson	Mississippi
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Richard Lochamy, M.D.	Junction City	Kansas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Clinical Investigation Specialists	Kenosha	Wisconsin
United States	Sante Clinical Research	Kerrville	Texas
United States	FMC Science	Lampasas	Texas
United States	Green and Seidner Family Practice Associates	Lansdale	Pennsylvania
United States	Clinical Research of South Nevada	Las Vegas	Nevada
United States	Sunrise Medical Research	Lauderdale Lakes	Florida
United States	BTC of Lincoln	Lincoln	Rhode Island
United States	National Research Institute	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Clinical Trials Management, LLC	Metairie	Louisiana
United States	Medcare Research	Miami	Florida
United States	Millenium Clinical Research, Inc.	Miami	Florida
United States	San Marcus Research Clinic, Inc.	Miami	Florida
United States	AR Developoment Solutions	Miami Lakes	Florida
United States	Cary Medical Clinic	Morrisville	North Carolina
United States	Clinical Investigations of Texas	Plano	Texas
United States	Carolinas Research Partners, LLC	Rock Hill	South Carolina
United States	Sun Research Institute	San Antonio	Texas
United States	Paradigm Clinical Research	San Diego	California
United States	Del Sol Research Mangagement, LLC	Tucson	Arizona
United States	Soma Medical Research	West Palm Beach	Florida
United States	Paradigm Research	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
NeuroBo Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG)	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using last observation carried forward (LOCF).	Baseline, EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in Fasting Serum TG		Baseline, Weeks 2, 6, 10 and 12
Secondary	Change From Baseline in Fasting Serum TG	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in TC	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in TC	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in Non-HDL-C	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in Non-HDL-C	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in VLDL-C	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in VLDL-C	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in HDL-C	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in HDL-C	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in Apolipoprotein B	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in Apolipoprotein B	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in Apolipoprotein A-I	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in Apolipoprotein A-I	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in Apolipoprotein A-II	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in Apolipoprotein A-II	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in Apolipoprotein C-II	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in Apolipoprotein C-II	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in Apolipoprotein C-III	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in Apolipoprotein C-III	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in Apolipoprotein E	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in Apolipoprotein E	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in LDL-C	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in LDL-C	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in LDL-TG	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in LDL-TG	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in VLDL-TG	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in VLDL-TG	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in HDL-TG	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in HDL-TG	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in Lipoprotein Size	Percent change from baseline in Particle size for VLDL, HDL and LDL were reported.	Baseline, Week 12
Secondary	Change From Baseline in Lipoprotein Size	Change from baseline in Particle size for VLDL, HDL and LDL were reported.	Baseline, Week 12
Secondary	Percent Change From Baseline in Lipoprotein Particle Number	Percent change from baseline in particle number for VLDL & chylomicron, LDL and IDL were reported.	Baseline, Week 12
Secondary	Change From Baseline in Lipoprotein Particle Number	Change from baseline in particle number for VLDL & chylomicron, LDL and IDL were reported.	Baseline, Week 12
Secondary	Percent Change From Baseline in HDL Particle Number		Baseline, Week 12
Secondary	Change From Baseline in HDL Particle Number		Baseline, Week 12
Secondary	Percent Change From Baseline in High-sensitivity C-reactive Protein	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in High-sensitivity C-reactive Protein	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in Fibrinogen	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in Fibrinogen	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in Serum Amyloid A	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in Serum Amyloid A	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in Adiponectin	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Week 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in Adiponectin	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Week 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in Angiopoietin 4	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Week 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in Angiopoietin 4	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Week 12 and EOS (average of week 10 and 12)
Secondary	Percent Change From Baseline in Interleukin-6	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Change From Baseline in Interleukin-6	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Secondary	Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L)	EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.	Weeks 10, 12 and EOS (average of week 10 and 12)