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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02944383
Other study ID # GEM-401
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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)
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