Mixed Dyslipidaemia, Severe Hypertriglyceridemia
Conditions
Keywords
Hypertriglycerides
Brief 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)
Interventions
DRUGGemcabene
Gemcabene tablets administered orally once daily, for 12 weeks.
DRUGPlacebo
Placebo tablets administered orally once daily, for 12 weeks.
Sponsors
NeuroBo Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG) | Baseline, EOS (average of week 10 and 12) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Serum TG | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in TC | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in TC | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in Non-HDL-C | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in Non-HDL-C | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in VLDL-C | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in VLDL-C | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in HDL-C | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in HDL-C | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in Apolipoprotein B | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in Apolipoprotein B | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in Apolipoprotein A-I | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in Apolipoprotein A-I | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in Apolipoprotein A-II | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in Apolipoprotein A-II | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in Apolipoprotein C-II | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in Apolipoprotein C-II | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in Apolipoprotein C-III | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in Apolipoprotein C-III | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in Apolipoprotein E | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in Apolipoprotein E | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in LDL-C | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in LDL-C | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in LDL-TG | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in LDL-TG | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in VLDL-TG | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in VLDL-TG | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in HDL-TG | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in HDL-TG | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in Lipoprotein Size | Baseline, Week 12 | Percent change from baseline in Particle size for VLDL, HDL and LDL were reported. |
| Change From Baseline in Lipoprotein Size | Baseline, Week 12 | Change from baseline in Particle size for VLDL, HDL and LDL were reported. |
| Percent Change From Baseline in Lipoprotein Particle Number | Baseline, Week 12 | Percent change from baseline in particle number for VLDL & chylomicron, LDL and IDL were reported. |
| Change From Baseline in Lipoprotein Particle Number | Baseline, Week 12 | Change from baseline in particle number for VLDL & chylomicron, LDL and IDL were reported. |
| Percent Change From Baseline in HDL Particle Number | Baseline, Week 12 | — |
| Change From Baseline in HDL Particle Number | Baseline, Week 12 | — |
| Percent Change From Baseline in High-sensitivity C-reactive Protein | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in High-sensitivity C-reactive Protein | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in Fibrinogen | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in Fibrinogen | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in Serum Amyloid A | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in Serum Amyloid A | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in Adiponectin | Baseline, Week 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in Fasting Serum TG | Baseline, Weeks 2, 6, 10 and 12 | — |
| Percent Change From Baseline in Angiopoietin 4 | Baseline, Week 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in Angiopoietin 4 | Baseline, Week 12 and EOS (average of week 10 and 12) | 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. |
| Percent Change From Baseline in Interleukin-6 | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in Interleukin-6 | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L) | Weeks 10, 12 and EOS (average of week 10 and 12) | 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. |
| Change From Baseline in Adiponectin | Baseline, Week 12 and EOS (average of week 10 and 12) | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gemcabene 600 mg Participants received 600 mg Gemcabene orally, once daily for 12 weeks. | 30 |
| Gemcabene 300 mg Participants received 300 mg Gemcabene orally, once daily for 12 weeks. | 30 |
| Placebo Participants received matching placebo orally, once daily for 12 weeks. | 31 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Gemcabene 600 mg | Gemcabene 300 mg | Placebo |
|---|---|---|---|---|
| Adiponectin | 4.2 Microgram per milliliter (μg/mL) | 3.9 Microgram per milliliter (μg/mL) | 4.3 Microgram per milliliter (μg/mL) | 4.4 Microgram per milliliter (μg/mL) |
| Age, Continuous | 54.1 years STANDARD_DEVIATION 10.4 | 56.3 years STANDARD_DEVIATION 9.1 | 51.5 years STANDARD_DEVIATION 9.5 | 54.6 years STANDARD_DEVIATION 12.06 |
| Angiopoietin 4 | 176.6 Nanogram per milliliter (ng/mL) | 204.1 Nanogram per milliliter (ng/mL) | 171.8 Nanogram per milliliter (ng/mL) | 165.7 Nanogram per milliliter (ng/mL) |
| Apolipoprotein A-I (ApoA-I) | 130.0 mg/dL | 130.0 mg/dL | 121.0 mg/dL | 133.0 mg/dL |
| Apolipoprotein A-II (ApoA-II) | 34.0 mg/dL | 35.0 mg/dL | 33.0 mg/dL | 34.0 mg/dL |
| Apolipoprotein B (ApoB) | 111.0 mg/dL | 113.5 mg/dL | 107.0 mg/dL | 110.0 mg/dL |
| Apolipoprotein B (ApoE) | 8.5 mg/dL | 8.1 mg/dL | 7.8 mg/dL | 9.1 mg/dL |
| Apolipoprotein C-II (ApoC-II) | 10 mg/dL | 10 mg/dL | 10 mg/dL | 10 mg/dL |
| Apolipoprotein C-III (ApoC-III) | 26.0 mg/dL | 25.5 mg/dL | 25.0 mg/dL | 27.0 mg/dL |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants | 12 Participants | 13 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 18 Participants | 17 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fibrinogen | 400.0 mg/dL | 418.5 mg/dL | 415.0 mg/dL | 375.0 mg/dL |
| HDL Particle Number | 29.700 Micro mole per Liter (umol/L) | 30.450 Micro mole per Liter (umol/L) | 28.500 Micro mole per Liter (umol/L) | 30.800 Micro mole per Liter (umol/L) |
| High-density lipoprotein cholesterol (HDL-C) | 28.0 mg/dL | 28.50 mg/dL | 28.00 mg/dL | 29.00 mg/dL |
| High-density lipoprotein Triglyceride (HDL-TG) | 35.0 mg/dL | 34.5 mg/dL | 33.0 mg/dL | 36.0 mg/dL |
| High-sensitivity C-reactive protein (hsCRP) | 3.20 mg/dL | 3.65 mg/dL | 2.75 mg/dL | 2.50 mg/dL |
| Interleukin-6 | 2.3 Picogram per milliliter (pg/mL) | 2.6 Picogram per milliliter (pg/mL) | 2.1 Picogram per milliliter (pg/mL) | 2.5 Picogram per milliliter (pg/mL) |
| Lipoprotein Particle Number Intermediate Density Lipoprotein (IDL) Particles | 137.0 Nano mole per Liter (nmol/L) | 164.5 Nano mole per Liter (nmol/L) | 114.0 Nano mole per Liter (nmol/L) | 137.0 Nano mole per Liter (nmol/L) |
| Lipoprotein Particle Number LDL Particles | 1259.00 Nano mole per Liter (nmol/L) | 1447.50 Nano mole per Liter (nmol/L) | 1228.50 Nano mole per Liter (nmol/L) | 1178.00 Nano mole per Liter (nmol/L) |
| Lipoprotein Particle Number VLDL and Chylomicron Particles | 147.20 Nano mole per Liter (nmol/L) | 147.90 Nano mole per Liter (nmol/L) | 145.35 Nano mole per Liter (nmol/L) | 140.90 Nano mole per Liter (nmol/L) |
| Lipoprotein size High density lipoprotein (HDL) | 8.700 Nanometer (nm) | 8.700 Nanometer (nm) | 8.500 Nanometer (nm) | 8.700 Nanometer (nm) |
| Lipoprotein size low density lipoprotein (LDL) | 19.60 Nanometer (nm) | 19.60 Nanometer (nm) | 19.60 Nanometer (nm) | 19.60 Nanometer (nm) |
| Lipoprotein size Very low density lipoprotein (VLDL) | 64.60 Nanometer (nm) | 64.90 Nanometer (nm) | 62.25 Nanometer (nm) | 68.80 Nanometer (nm) |
| Low-density lipoprotein cholesterol (LDL-C) | 87.00 mg/dL | 97.00 mg/dL | 87.00 mg/dL | 76.00 mg/dL |
| Low-density lipoprotein Triglyceride (LDL-TG) | 53.0 mg/dL | 59.0 mg/dL | 47.5 mg/dL | 54.0 mg/dL |
| Non-high-density lipoprotein cholesterol (non-HDL-C) | 205.00 mg/dL | 238.75 mg/dL | 190.0 mg/dL | 201.00 mg/dL |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 82 Participants | 28 Participants | 29 Participants | 25 Participants |
| Serum amyloid A | 5.3 Milligram per Liter (mg/L) | 5.9 Milligram per Liter (mg/L) | 4.8 Milligram per Liter (mg/L) | 5.0 Milligram per Liter (mg/L) |
| Sex: Female, Male Female | 18 Participants | 5 Participants | 1 Participants | 12 Participants |
| Sex: Female, Male Male | 73 Participants | 25 Participants | 29 Participants | 19 Participants |
| Total Cholesterol (TC) | 237.00 mg/dL | 273.00 mg/dL | 219.00 mg/dL | 235.00 mg/dL |
| Triglycerides [TG] | 643.0 Milligram per deciliter (mg/dL) | 637 Milligram per deciliter (mg/dL) | 641.17 Milligram per deciliter (mg/dL) | 658.33 Milligram per deciliter (mg/dL) |
| Very low-density lipoprotein cholesterol (VLDL-C) | 110.00 mg/dL | 108.50 mg/dL | 102.50 mg/dL | 117.00 mg/dL |
| Very low-density lipoprotein Triglyceride (VLDL-TG) | 506.0 mg/dL | 476.0 mg/dL | 462.0 mg/dL | 541.0 mg/dL |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 31 |
| other Total, other adverse events | 16 / 30 | 14 / 30 | 20 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 1 / 31 |
Outcome results
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).
Time frame: Baseline, EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG) | -47.32 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG) | -32.95 Percent Change |
| Placebo | Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG) | -27.30 Percent Change |
p-value: 0.006395% CI: [-33.07, -4.25]Ranked ANCOVA
p-value: 0.23595% CI: [-25.88, 7.05]Ranked ANCOVA
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.
Time frame: Baseline, Week 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in Adiponectin | Week 12 | 0.3 μg/mL |
| Gemcabene 600 mg | Change From Baseline in Adiponectin | EOS | 0.3 μg/mL |
| Gemcabene 300 mg | Change From Baseline in Adiponectin | Week 12 | 0.3 μg/mL |
| Gemcabene 300 mg | Change From Baseline in Adiponectin | EOS | 0.3 μg/mL |
| Placebo | Change From Baseline in Adiponectin | Week 12 | 0.0 μg/mL |
| Placebo | Change From Baseline in Adiponectin | EOS | 0.0 μg/mL |
Comparison: Week 12p-value: 0.0768Ranked ANCOVA
Comparison: Week 12p-value: 0.4346Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.0768Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.4346Ranked ANCOVA
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.
Time frame: Baseline, Week 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in Angiopoietin 4 | Week 12 | 15.7 ng/mL |
| Gemcabene 600 mg | Change From Baseline in Angiopoietin 4 | EOS | 15.7 ng/mL |
| Gemcabene 300 mg | Change From Baseline in Angiopoietin 4 | Week 12 | -2.0 ng/mL |
| Gemcabene 300 mg | Change From Baseline in Angiopoietin 4 | EOS | -2.0 ng/mL |
| Placebo | Change From Baseline in Angiopoietin 4 | Week 12 | 2.8 ng/mL |
| Placebo | Change From Baseline in Angiopoietin 4 | EOS | 2.8 ng/mL |
Comparison: Week 12p-value: 0.3998Ranked ANCOVA
Comparison: Week 12p-value: 0.3659Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.3998Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.3659Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein A-I | Week 12 | 8.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein A-I | Week 10 | 5.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein A-I | EOS | 1.5 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein A-I | Week 12 | 4.5 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein A-I | Week 10 | 6.0 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein A-I | EOS | 5.5 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein A-I | Week 10 | 4.0 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein A-I | EOS | 2.5 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein A-I | Week 12 | 2.5 mg/dL |
Comparison: Week 10p-value: 0.1521Ranked ANCOVA
Comparison: Week 10p-value: 0.8982Ranked ANCOVA
Comparison: Week 12p-value: 0.6228Ranked ANCOVA
Comparison: Week 12p-value: 0.9622Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.6643Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.9071Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein A-II | Week 12 | 0.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein A-II | Week 10 | -1.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein A-II | EOS | 0.0 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein A-II | Week 12 | 1.5 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein A-II | Week 10 | 2.0 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein A-II | EOS | 1.8 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein A-II | Week 10 | 0.0 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein A-II | EOS | 0.0 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein A-II | Week 12 | 0.0 mg/dL |
Comparison: Week 10p-value: 0.4623Ranked ANCOVA
Comparison: Week 10p-value: 0.1678Ranked ANCOVA
Comparison: Week 12p-value: 0.439Ranked ANCOVA
Comparison: Week 12p-value: 0.129Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.9627Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.0911Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein B | Week 12 | -7.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein B | Week 10 | -10.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein B | EOS | -8.5 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein B | Week 12 | 0.5 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein B | Week 10 | -4.0 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein B | EOS | -1.8 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein B | Week 10 | 0.0 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein B | EOS | 2.8 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein B | Week 12 | 5.5 mg/dL |
Comparison: Week 10p-value: 0.0133Ranked ANCOVA
Comparison: Week 10p-value: 0.2044Ranked ANCOVA
Comparison: Week 12p-value: 0.0855Ranked ANCOVA
Comparison: Week 12p-value: 0.5114Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.0289Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.295Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein C-II | Week 12 | 0.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein C-II | Week 10 | 0.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein C-II | EOS | 0.0 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein C-II | Week 12 | 0.0 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein C-II | Week 10 | 0.0 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein C-II | EOS | 0.0 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein C-II | Week 10 | 0.0 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein C-II | EOS | 0.0 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein C-II | Week 12 | 0.0 mg/dL |
Comparison: Week 10p-value: 0.2857ranked ANCOVA
Comparison: Week 10p-value: 0.4486Ranked ANCOVA
Comparison: Week 12p-value: 0.764Ranked ANCOVA
Comparison: Week 12p-value: 0.056Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.9954Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.1298Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein C-III | Week 12 | -4.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein C-III | Week 10 | -6.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein C-III | EOS | -5.5 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein C-III | Week 12 | -2.0 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein C-III | Week 10 | -4.0 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein C-III | EOS | -3.3 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein C-III | Week 10 | -1.0 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein C-III | EOS | -2.0 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein C-III | Week 12 | -3.0 mg/dL |
Comparison: Week 10p-value: 0.0345Ranked ANCOVA
Comparison: Week 10p-value: 0.2709Ranked ANCOVA
Comparison: Week 12p-value: 0.3255Ranked ANCOVA
Comparison: Week 12p-value: 0.7391Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.0808Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.6509Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein E | Week 12 | -2.2 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein E | Week 10 | -3.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Apolipoprotein E | EOS | -2.9 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein E | Week 12 | -1.4 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein E | Week 10 | -1.8 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Apolipoprotein E | EOS | -1.3 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein E | Week 10 | -0.9 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein E | EOS | -0.9 mg/dL |
| Placebo | Change From Baseline in Apolipoprotein E | Week 12 | -1.8 mg/dL |
Comparison: Week 10p-value: 0.0002Ranked ANCOVA
Comparison: Week 10p-value: 0.0161Ranked ANCOVA
Comparison: Week 12p-value: 0.3043Ranked ANCOVA
Comparison: Week 12p-value: 0.4639Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.021Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.0992Ranked ANCOVA
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.
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in Fasting Serum TG | Week 12 | -234.33 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Fasting Serum TG | Week 10 | -298.33 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Fasting Serum TG | Week 2 | -221.83 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Fasting Serum TG | Week 6 | -272.33 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Fasting Serum TG | EOS | -288.42 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Fasting Serum TG | Week 10 | -173.50 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Fasting Serum TG | Week 2 | -161.00 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Fasting Serum TG | Week 6 | -173.83 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Fasting Serum TG | Week 12 | -230.67 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Fasting Serum TG | EOS | -219.67 mg/dL |
| Placebo | Change From Baseline in Fasting Serum TG | EOS | -154.00 mg/dL |
| Placebo | Change From Baseline in Fasting Serum TG | Week 12 | -202.67 mg/dL |
| Placebo | Change From Baseline in Fasting Serum TG | Week 2 | -163.67 mg/dL |
| Placebo | Change From Baseline in Fasting Serum TG | Week 10 | -131.00 mg/dL |
| Placebo | Change From Baseline in Fasting Serum TG | Week 6 | -130.00 mg/dL |
Comparison: Week 2p-value: 0.178Ranked ANCOVA
Comparison: Week 2p-value: 0.7615Ranked ANCOVA
Comparison: Week 6p-value: 0.0162Ranked ANCOVA
Comparison: Week 6p-value: 0.371Ranked ANCOVA
Comparison: Week 10p-value: 0.001Ranked ANCOVA
Comparison: Week 10p-value: 0.0988Ranked ANCOVA
Comparison: Week 12p-value: 0.2594Ranked ANCOVA
Comparison: Week 12p-value: 0.9099Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.0219Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.3494Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in Fibrinogen | Week 12 | -7.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Fibrinogen | Week 10 | 5.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Fibrinogen | EOS | -1.0 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Fibrinogen | Week 12 | -50.0 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Fibrinogen | Week 10 | -22.0 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Fibrinogen | EOS | -35.0 mg/dL |
| Placebo | Change From Baseline in Fibrinogen | Week 10 | -15.0 mg/dL |
| Placebo | Change From Baseline in Fibrinogen | EOS | -14.3 mg/dL |
| Placebo | Change From Baseline in Fibrinogen | Week 12 | -12.0 mg/dL |
Comparison: Week 10p-value: 0.155Ranked ANCOVA
Comparison: Week 10p-value: 0.6604Ranked ANCOVA
Comparison: Week 12p-value: 0.0952Ranked ANCOVA
Comparison: Week 12p-value: 0.3006Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.0642Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.3185Ranked ANCOVA
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.
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in HDL-C | Week 12 | 4.00 mg/dL |
| Gemcabene 600 mg | Change From Baseline in HDL-C | Week 10 | 2.00 mg/dL |
| Gemcabene 600 mg | Change From Baseline in HDL-C | Week 2 | 2.00 mg/dL |
| Gemcabene 600 mg | Change From Baseline in HDL-C | Week 6 | 1.50 mg/dL |
| Gemcabene 600 mg | Change From Baseline in HDL-C | EOS | 3.00 mg/dL |
| Gemcabene 300 mg | Change From Baseline in HDL-C | Week 10 | 2.00 mg/dL |
| Gemcabene 300 mg | Change From Baseline in HDL-C | Week 2 | 1.00 mg/dL |
| Gemcabene 300 mg | Change From Baseline in HDL-C | Week 6 | 2.00 mg/dL |
| Gemcabene 300 mg | Change From Baseline in HDL-C | Week 12 | 2.00 mg/dL |
| Gemcabene 300 mg | Change From Baseline in HDL-C | EOS | 2.00 mg/dL |
| Placebo | Change From Baseline in HDL-C | EOS | 2.00 mg/dL |
| Placebo | Change From Baseline in HDL-C | Week 12 | 2.00 mg/dL |
| Placebo | Change From Baseline in HDL-C | Week 2 | 1 mg/dL |
| Placebo | Change From Baseline in HDL-C | Week 10 | 3.00 mg/dL |
| Placebo | Change From Baseline in HDL-C | Week 6 | 0.00 mg/dL |
Comparison: Week 2p-value: 0.1485Ranked ANCOVA
Comparison: Week 2p-value: 0.6008Ranked ANCOVA
Comparison: Week 6p-value: 0.9409Ranked ANCOVA
Comparison: Week 6p-value: 0.9292Ranked ANCOVA
Comparison: Week 10p-value: 0.8455Ranked ANCOVA
Comparison: Week 10p-value: 0.5256Ranked ANCOVA
Comparison: Week 12p-value: 0.9217Ranked ANCOVA
Comparison: Week 12p-value: 0.7401Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.9386Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.6352Ranked ANCOVA
Secondary
Change From Baseline in HDL Particle Number
Time frame: Baseline, Week 12
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcabene 600 mg | Change From Baseline in HDL Particle Number | -0.200 umol/L |
| Gemcabene 300 mg | Change From Baseline in HDL Particle Number | 0.100 umol/L |
| Placebo | Change From Baseline in HDL Particle Number | 0.000 umol/L |
p-value: 0.8602Ranked ANCOVA
p-value: 0.8555Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in HDL-TG | Week 12 | -8.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in HDL-TG | Week 10 | -8.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in HDL-TG | EOS | -7.0 mg/dL |
| Gemcabene 300 mg | Change From Baseline in HDL-TG | Week 12 | -5.5 mg/dL |
| Gemcabene 300 mg | Change From Baseline in HDL-TG | Week 10 | -2.0 mg/dL |
| Gemcabene 300 mg | Change From Baseline in HDL-TG | EOS | -3.5 mg/dL |
| Placebo | Change From Baseline in HDL-TG | Week 10 | -2.0 mg/dL |
| Placebo | Change From Baseline in HDL-TG | EOS | -0.5 mg/dL |
| Placebo | Change From Baseline in HDL-TG | Week 12 | -4.0 mg/dL |
Comparison: Week 10p-value: 0.0023Ranked ANCOVA
Comparison: Week 10p-value: 0.0356Ranked ANCOVA
Comparison: Week 12p-value: 0.2284Ranked ANCOVA
Comparison: Week 12p-value: 0.0213Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.033Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.0221Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in High-sensitivity C-reactive Protein | Week 12 | -0.60 mg/dL |
| Gemcabene 600 mg | Change From Baseline in High-sensitivity C-reactive Protein | Week 10 | -0.90 mg/dL |
| Gemcabene 600 mg | Change From Baseline in High-sensitivity C-reactive Protein | EOS | -0.75 mg/dL |
| Gemcabene 300 mg | Change From Baseline in High-sensitivity C-reactive Protein | Week 12 | -0.50 mg/dL |
| Gemcabene 300 mg | Change From Baseline in High-sensitivity C-reactive Protein | Week 10 | -0.40 mg/dL |
| Gemcabene 300 mg | Change From Baseline in High-sensitivity C-reactive Protein | EOS | -0.28 mg/dL |
| Placebo | Change From Baseline in High-sensitivity C-reactive Protein | Week 10 | -0.10 mg/dL |
| Placebo | Change From Baseline in High-sensitivity C-reactive Protein | EOS | -0.02 mg/dL |
| Placebo | Change From Baseline in High-sensitivity C-reactive Protein | Week 12 | 0.10 mg/dL |
Comparison: Week 10p-value: 0.2397Ranked ANCOVA
Comparison: Week 10p-value: 0.5399Ranked ANCOVA
Comparison: Week 12p-value: 0.0409Ranked ANCOVA
Comparison: Week 12p-value: 0.0073Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.0976Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.1899Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in Interleukin-6 | Week 12 | -0.1 pg/mL |
| Gemcabene 600 mg | Change From Baseline in Interleukin-6 | Week 10 | -0.1 pg/mL |
| Gemcabene 600 mg | Change From Baseline in Interleukin-6 | EOS | -0.1 pg/mL |
| Gemcabene 300 mg | Change From Baseline in Interleukin-6 | Week 12 | -0.2 pg/mL |
| Gemcabene 300 mg | Change From Baseline in Interleukin-6 | Week 10 | -0.1 pg/mL |
| Gemcabene 300 mg | Change From Baseline in Interleukin-6 | EOS | -0.2 pg/mL |
| Placebo | Change From Baseline in Interleukin-6 | Week 10 | -0.0 pg/mL |
| Placebo | Change From Baseline in Interleukin-6 | EOS | -0.1 pg/mL |
| Placebo | Change From Baseline in Interleukin-6 | Week 12 | -0.2 pg/mL |
Comparison: Week 12p-value: 0.4588Ranked ANCOVA
Comparison: Week 10p-value: 0.9772Ranked ANCOVA
Comparison: Week 10p-value: 0.5213Ranked ANCOVA
Comparison: Week 12p-value: 0.1582Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.4264Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.8107Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in LDL-C | Week 12 | -10.00 mg/dL |
| Gemcabene 600 mg | Change From Baseline in LDL-C | Week 10 | -12.00 mg/dL |
| Gemcabene 600 mg | Change From Baseline in LDL-C | EOS | -11.50 mg/dL |
| Gemcabene 300 mg | Change From Baseline in LDL-C | Week 12 | 4.50 mg/dL |
| Gemcabene 300 mg | Change From Baseline in LDL-C | Week 10 | 3.00 mg/dL |
| Gemcabene 300 mg | Change From Baseline in LDL-C | EOS | 5.75 mg/dL |
| Placebo | Change From Baseline in LDL-C | Week 10 | 0.00 mg/dL |
| Placebo | Change From Baseline in LDL-C | EOS | 8.75 mg/dL |
| Placebo | Change From Baseline in LDL-C | Week 12 | 17.50 mg/dL |
Comparison: Week 10p-value: 0.1705Ranked ANCOVA
Comparison: Week 10p-value: 0.9193Ranked ANCOVA
Comparison: Week 12p-value: 0.0224Ranked ANCOVA
Comparison: Week 12p-value: 0.2387Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.06Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.6878Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in LDL-TG | Week 12 | -10.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in LDL-TG | Week 10 | -11.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in LDL-TG | EOS | -12.5 mg/dL |
| Gemcabene 300 mg | Change From Baseline in LDL-TG | Week 12 | -4.0 mg/dL |
| Gemcabene 300 mg | Change From Baseline in LDL-TG | Week 10 | -6.5 mg/dL |
| Gemcabene 300 mg | Change From Baseline in LDL-TG | EOS | -4.0 mg/dL |
| Placebo | Change From Baseline in LDL-TG | Week 10 | 0.5 mg/dL |
| Placebo | Change From Baseline in LDL-TG | EOS | -3.3 mg/dL |
| Placebo | Change From Baseline in LDL-TG | Week 12 | -3.0 mg/dL |
Comparison: Week 10p-value: 0.0084Ranked ANCOVA
Comparison: Week 10p-value: 0.0047Ranked ANCOVA
Comparison: Week 12p-value: 0.1574Ranked ANCOVA
Comparison: Week 12p-value: 0.3235Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.0367Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.0948Ranked ANCOVA
Secondary
Change From Baseline in Lipoprotein Particle Number
Change from baseline in particle number for VLDL & chylomicron, LDL and IDL were reported.
Time frame: Baseline, Week 12
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in Lipoprotein Particle Number | IDL Particles | -67.0 nmol/L |
| Gemcabene 600 mg | Change From Baseline in Lipoprotein Particle Number | VLDL and Chylomicron Particles | -10.90 nmol/L |
| Gemcabene 600 mg | Change From Baseline in Lipoprotein Particle Number | LDL Particles | -103.00 nmol/L |
| Gemcabene 300 mg | Change From Baseline in Lipoprotein Particle Number | IDL Particles | -14.0 nmol/L |
| Gemcabene 300 mg | Change From Baseline in Lipoprotein Particle Number | VLDL and Chylomicron Particles | -6.40 nmol/L |
| Gemcabene 300 mg | Change From Baseline in Lipoprotein Particle Number | LDL Particles | -82.00 nmol/L |
| Placebo | Change From Baseline in Lipoprotein Particle Number | VLDL and Chylomicron Particles | -4.30 nmol/L |
| Placebo | Change From Baseline in Lipoprotein Particle Number | LDL Particles | 160.0 nmol/L |
| Placebo | Change From Baseline in Lipoprotein Particle Number | IDL Particles | 1.0 nmol/L |
Comparison: VLDL \& Chylomicron Particlesp-value: 0.1251Ranked ANCOVA
Comparison: VLDL \& Chylomicron Particlesp-value: 0.9047Ranked ANCOVA
Comparison: LDL Particlesp-value: 0.0788Ranked ANCOVA
Comparison: LDL Particlesp-value: 0.1222Ranked ANCOVA
Comparison: IDL Particlesp-value: 0.0734Ranked ANCOVA
Comparison: IDL Particlesp-value: 0.421Ranked ANCOVA
Secondary
Change From Baseline in Lipoprotein Size
Change from baseline in Particle size for VLDL, HDL and LDL were reported.
Time frame: Baseline, Week 12
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in Lipoprotein Size | LDL | 0.00 nm |
| Gemcabene 600 mg | Change From Baseline in Lipoprotein Size | VLDL | -5.10 nm |
| Gemcabene 600 mg | Change From Baseline in Lipoprotein Size | HDL | 0.000 nm |
| Gemcabene 300 mg | Change From Baseline in Lipoprotein Size | LDL | 0.00 nm |
| Gemcabene 300 mg | Change From Baseline in Lipoprotein Size | VLDL | -3.90 nm |
| Gemcabene 300 mg | Change From Baseline in Lipoprotein Size | HDL | 0.000 nm |
| Placebo | Change From Baseline in Lipoprotein Size | VLDL | -3.10 nm |
| Placebo | Change From Baseline in Lipoprotein Size | HDL | 0.000 nm |
| Placebo | Change From Baseline in Lipoprotein Size | LDL | 0.10 nm |
Comparison: VLDLp-value: 0.2721Ranked ANCOVA
Comparison: VLDLp-value: 0.5669Ranked ANCOVA
Comparison: LDLp-value: 0.1686Ranked ANCOVA
Comparison: LDLp-value: 0.4308Ranked ANCOVA
Comparison: HDLp-value: 0.5495Ranked ANCOVA
Comparison: HDLp-value: 0.2384Ranked ANCOVA
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.
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in Non-HDL-C | Week 12 | -29.00 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Non-HDL-C | Week 10 | -45.00 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Non-HDL-C | Week 2 | -30.75 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Non-HDL-C | Week 6 | -43.50 mg/dL |
| Gemcabene 600 mg | Change From Baseline in Non-HDL-C | EOS | -36.50 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Non-HDL-C | Week 10 | -23.00 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Non-HDL-C | Week 2 | -12.25 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Non-HDL-C | Week 6 | -19.75 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Non-HDL-C | Week 12 | -22.25 mg/dL |
| Gemcabene 300 mg | Change From Baseline in Non-HDL-C | EOS | -21.25 mg/dL |
| Placebo | Change From Baseline in Non-HDL-C | EOS | -7.00 mg/dL |
| Placebo | Change From Baseline in Non-HDL-C | Week 12 | -16.00 mg/dL |
| Placebo | Change From Baseline in Non-HDL-C | Week 2 | -6.50 mg/dL |
| Placebo | Change From Baseline in Non-HDL-C | Week 10 | -7.50 mg/dL |
| Placebo | Change From Baseline in Non-HDL-C | Week 6 | -16.50 mg/dL |
Comparison: Week 10p-value: 0.0592Ranked ANCOVA
Comparison: Week 12p-value: 0.117Ranked ANCOVA
Comparison: Week 12p-value: 0.3138Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.009Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.1317Ranked ANCOVA
Comparison: Week 2p-value: 0.0211Ranked ANCOVA
Comparison: Week 2p-value: 0.1304Ranked ANCOVA
Comparison: Week 6p-value: 0.0318Ranked ANCOVA
Comparison: Week 6p-value: 0.4607Ranked ANCOVA
Comparison: Week 10p-value: 0.0012Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in Serum Amyloid A | Week 12 | -2.1 mg/L |
| Gemcabene 600 mg | Change From Baseline in Serum Amyloid A | Week 10 | -1.5 mg/L |
| Gemcabene 600 mg | Change From Baseline in Serum Amyloid A | EOS | -1.5 mg/L |
| Gemcabene 300 mg | Change From Baseline in Serum Amyloid A | Week 12 | -0.9 mg/L |
| Gemcabene 300 mg | Change From Baseline in Serum Amyloid A | Week 10 | -0.6 mg/L |
| Gemcabene 300 mg | Change From Baseline in Serum Amyloid A | EOS | -0.8 mg/L |
| Placebo | Change From Baseline in Serum Amyloid A | Week 10 | -0.4 mg/L |
| Placebo | Change From Baseline in Serum Amyloid A | EOS | -0.2 mg/L |
| Placebo | Change From Baseline in Serum Amyloid A | Week 12 | -0.3 mg/L |
Comparison: Week 10p-value: 0.1362Ranked ANCOVA
Comparison: Week 10p-value: 0.6458Ranked ANCOVA
Comparison: Week 12p-value: 0.0209Ranked ANCOVA
Comparison: Week 12p-value: 0.0822Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.0504Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.1315Ranked ANCOVA
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.
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in TC | Week 12 | -28.25 mg/dL |
| Gemcabene 600 mg | Change From Baseline in TC | Week 10 | -41.25 mg/dL |
| Gemcabene 600 mg | Change From Baseline in TC | Week 2 | -25.75 mg/dL |
| Gemcabene 600 mg | Change From Baseline in TC | Week 6 | -41.50 mg/dL |
| Gemcabene 600 mg | Change From Baseline in TC | EOS | -35.50 mg/dL |
| Gemcabene 300 mg | Change From Baseline in TC | Week 10 | -16.00 mg/dL |
| Gemcabene 300 mg | Change From Baseline in TC | Week 2 | -10.25 mg/dL |
| Gemcabene 300 mg | Change From Baseline in TC | Week 6 | -18.75 mg/dL |
| Gemcabene 300 mg | Change From Baseline in TC | Week 12 | -19.75 mg/dL |
| Gemcabene 300 mg | Change From Baseline in TC | EOS | -14.25 mg/dL |
| Placebo | Change From Baseline in TC | EOS | -3.00 mg/dL |
| Placebo | Change From Baseline in TC | Week 12 | -14.00 mg/dL |
| Placebo | Change From Baseline in TC | Week 2 | -5.50 mg/dL |
| Placebo | Change From Baseline in TC | Week 10 | -2.50 mg/dL |
| Placebo | Change From Baseline in TC | Week 6 | -13.50 mg/dL |
Comparison: Week 2p-value: 0.0386Ranked ANCOVA
Comparison: Week 2p-value: 0.1206Ranked ANCOVA
Comparison: Week 6p-value: 0.0364Ranked ANCOVA
Comparison: Week 6p-value: 0.4312Ranked ANCOVA
Comparison: Week 10p-value: 0.001Ranked ANCOVA
Comparison: Week 10p-value: 0.0407Ranked ANCOVA
Comparison: Week 12p-value: 0.1433Ranked ANCOVA
Comparison: Week 12p-value: 0.2866Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.0056Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.0789Ranked ANCOVA
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.
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, Number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in VLDL-C | Week 2 | -47.00 mg/dL |
| Gemcabene 600 mg | Change From Baseline in VLDL-C | Week 12 | -26.00 mg/dL |
| Gemcabene 600 mg | Change From Baseline in VLDL-C | EOS | -32.50 mg/dL |
| Gemcabene 600 mg | Change From Baseline in VLDL-C | Week 10 | -25.50 mg/dL |
| Gemcabene 600 mg | Change From Baseline in VLDL-C | Week 6 | -37.50 mg/dL |
| Gemcabene 300 mg | Change From Baseline in VLDL-C | Week 10 | -15.00 mg/dL |
| Gemcabene 300 mg | Change From Baseline in VLDL-C | EOS | -13.00 mg/dL |
| Gemcabene 300 mg | Change From Baseline in VLDL-C | Week 2 | -60 mg/dL |
| Gemcabene 300 mg | Change From Baseline in VLDL-C | Week 6 | -50.00 mg/dL |
| Gemcabene 300 mg | Change From Baseline in VLDL-C | Week 12 | -19.00 mg/dL |
| Placebo | Change From Baseline in VLDL-C | EOS | -19.50 mg/dL |
| Placebo | Change From Baseline in VLDL-C | Week 12 | -24.00 mg/dL |
| Placebo | Change From Baseline in VLDL-C | Week 10 | -7.00 mg/dL |
| Placebo | Change From Baseline in VLDL-C | Week 6 | -31.50 mg/dL |
| Placebo | Change From Baseline in VLDL-C | Week 2 | -29.00 mg/dL |
Comparison: Week 2p-value: 0.3714Ranked ANCOVA
Comparison: Week 2p-value: 0.4415Ranked ANCOVA
Comparison: Week 6p-value: 0.7902Ranked ANCOVA
Comparison: Week 6p-value: 0.6999Ranked ANCOVA
Comparison: Week 10p-value: 0.0015Ranked ANCOVA
Comparison: Week 10p-value: 0.0796Ranked ANCOVA
Comparison: Week 12p-value: 0.4225Ranked ANCOVA
Comparison: Week 12p-value: 0.7687Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.0437Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.2735Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Change From Baseline in VLDL-TG | Week 12 | -139.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in VLDL-TG | Week 10 | -170.0 mg/dL |
| Gemcabene 600 mg | Change From Baseline in VLDL-TG | EOS | -164.0 mg/dL |
| Gemcabene 300 mg | Change From Baseline in VLDL-TG | Week 12 | -103.5 mg/dL |
| Gemcabene 300 mg | Change From Baseline in VLDL-TG | Week 10 | -129.5 mg/dL |
| Gemcabene 300 mg | Change From Baseline in VLDL-TG | EOS | -116.5 mg/dL |
| Placebo | Change From Baseline in VLDL-TG | Week 10 | -77.0 mg/dL |
| Placebo | Change From Baseline in VLDL-TG | EOS | -126.8 mg/dL |
| Placebo | Change From Baseline in VLDL-TG | Week 12 | -193.5 mg/dL |
Comparison: Week 10p-value: 0.0085Ranked ANCOVA
Comparison: Week 10p-value: 0.2112Ranked ANCOVA
Comparison: Week 12p-value: 0.7301Ranked ANCOVA
Comparison: Week 12p-value: 0.6283Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.0919Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.5497Ranked ANCOVA
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.
Time frame: Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcabene 600 mg | Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L) | Week 12 | 63.3 Percentage of participants |
| Gemcabene 600 mg | Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L) | Week 10 | 73.3 Percentage of participants |
| Gemcabene 600 mg | Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L) | EOS | 66.7 Percentage of participants |
| Gemcabene 300 mg | Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L) | Week 12 | 53.3 Percentage of participants |
| Gemcabene 300 mg | Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L) | Week 10 | 63.3 Percentage of participants |
| Gemcabene 300 mg | Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L) | EOS | 56.7 Percentage of participants |
| Placebo | Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L) | Week 10 | 41.9 Percentage of participants |
| Placebo | Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L) | EOS | 45.2 Percentage of participants |
| Placebo | Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L) | Week 12 | 41.9 Percentage of participants |
Comparison: Week 10p-value: 0.009395% CI: [1.51, 19.08]Regression, Logistic
Comparison: Week 10p-value: 0.10795% CI: [0.82, 8.07]Regression, Logistic
Comparison: Week 12p-value: 0.086595% CI: [0.87, 7.53]Regression, Logistic
Comparison: Week 12p-value: 0.39995% CI: [0.55, 4.48]Regression, Logistic
Comparison: EOS (average of week 10 and 12)p-value: 0.077295% CI: [0.9, 8.42]Regression, Logistic
Comparison: EOS (average of week 10 and 12)p-value: 0.431595% CI: [0.53, 4.48]Regression, Logistic
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.
Time frame: Baseline, Week 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in Adiponectin | Week 12 | 12.9 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Adiponectin | EOS | 12.9 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Adiponectin | Week 12 | 12.4 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Adiponectin | EOS | 12.4 Percent Change |
| Placebo | Percent Change From Baseline in Adiponectin | Week 12 | 1.2 Percent Change |
| Placebo | Percent Change From Baseline in Adiponectin | EOS | 1.2 Percent Change |
Comparison: Week 12p-value: 0.0843Ranked ANCOVA
Comparison: Week 12p-value: 0.3587Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.084395% CI: [-0.54, 25.51]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.358795% CI: [-3.7, 21.39]Ranked ANCOVA
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.
Time frame: Baseline, Week 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in Angiopoietin 4 | Week 12 | 8.5 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Angiopoietin 4 | EOS | 8.5 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Angiopoietin 4 | Week 12 | -1.6 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Angiopoietin 4 | EOS | -1.6 Percent Change |
| Placebo | Percent Change From Baseline in Angiopoietin 4 | Week 12 | 1.1 Percent Change |
| Placebo | Percent Change From Baseline in Angiopoietin 4 | EOS | 1.1 Percent Change |
Comparison: Week 12p-value: 0.5411Ranked ANCOVA
Comparison: Week 12p-value: 0.2574Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.541195% CI: [-9.59, 14.86]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.257495% CI: [-19.3, 5.76]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein A-I | Week 12 | 5.9 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein A-I | Week 10 | -3.3 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein A-I | EOS | 1.2 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein A-I | Week 12 | 4.0 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein A-I | Week 10 | 5.1 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein A-I | EOS | 4.6 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein A-I | Week 10 | 2.7 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein A-I | EOS | 2.0 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein A-I | Week 12 | 2.1 Percent Change |
Comparison: Week 10p-value: 0.1992Ranked ANCOVA
Comparison: Week 10p-value: 0.9945Ranked ANCOVA
Comparison: Week 12p-value: 0.5139Ranked ANCOVA
Comparison: Week 12p-value: 0.8085Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.764495% CI: [-6.31, 4.85]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.949995% CI: [-4.34, 6.66]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein A-II | Week 12 | 0.0 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein A-II | Week 10 | -3.2 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein A-II | EOS | 0.0 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein A-II | Week 12 | 4.5 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein A-II | Week 10 | 6.9 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein A-II | EOS | 5.3 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein A-II | Week 10 | 0.0 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein A-II | EOS | 0.0 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein A-II | Week 12 | 0.0 Percent Change |
Comparison: Week 10p-value: 0.5647Ranked ANCOVA
Comparison: Week 10p-value: 0.1073Ranked ANCOVA
Comparison: Week 12p-value: 0.3858Ranked ANCOVA
Comparison: Week 12p-value: 0.0916Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.947395% CI: [-5.56, 5.26]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.091195% CI: [-1.83, 9.95]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, Number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein B | Week 12 | -4.7 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein B | Week 10 | -10.5 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein B | EOS | -5.9 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein B | Week 12 | 0.5 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein B | Week 10 | -2.7 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein B | EOS | -1.9 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein B | Week 10 | 0.0 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein B | EOS | 2.8 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein B | Week 12 | 4.8 Percent Change |
Comparison: Week 10p-value: 0.0165Ranked ANCOVA
Comparison: Week 10p-value: 0.3075Ranked ANCOVA
Comparison: Week 12p-value: 0.1069Ranked ANCOVA
Comparison: Week 12p-value: 0.6101Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.035195% CI: [-23.79, -1.08]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.374695% CI: [-9.86, 4.25]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein C-II | Week 12 | 0.0 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein C-II | Week 10 | 0.0 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein C-II | EOS | 0.0 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein C-II | Week 12 | 0.0 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein C-II | Week 10 | 0.0 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein C-II | EOS | 0.0 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein C-II | Week 10 | 0.0 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein C-II | EOS | 0.0 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein C-II | Week 12 | 0.0 Percent Change |
Comparison: Week 10p-value: 0.2882Ranked ANCOVA
Comparison: Week 10p-value: 0.4474Ranked ANCOVA
Comparison: Week 12p-value: 0.7875Ranked ANCOVA
Comparison: Week 12p-value: 0.06Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.983295% CI: [0, 0]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.135295% CI: [0, 0]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein C-III | Week 12 | -17.6 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein C-III | Week 10 | -21.1 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein C-III | EOS | -17.6 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein C-III | Week 12 | -6.4 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein C-III | Week 10 | -14.3 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein C-III | EOS | -11.3 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein C-III | Week 10 | -3.6 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein C-III | EOS | -8.1 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein C-III | Week 12 | -10.7 Percent Change |
Comparison: Week 10p-value: 0.0161Ranked ANCOVA
Comparison: Week 10p-value: 0.1806Ranked ANCOVA
Comparison: Week 12p-value: 0.2657Ranked ANCOVA
Comparison: Week 12p-value: 0.5996Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.02795% CI: [-28.81, 2.08]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.526395% CI: [-16.88, 15.5]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein E | Week 12 | -27.5 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein E | Week 10 | -36.3 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Apolipoprotein E | EOS | -33.2 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein E | Week 12 | -14.6 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein E | Week 10 | -22.6 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Apolipoprotein E | EOS | -16.7 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein E | Week 10 | -9.2 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein E | EOS | -10.4 Percent Change |
| Placebo | Percent Change From Baseline in Apolipoprotein E | Week 12 | -25.7 Percent Change |
Comparison: Week 10p-value: 0.0004Ranked ANCOVA
Comparison: Week 10p-value: 0.0412Ranked ANCOVA
Comparison: Week 12p-value: 0.1937Ranked ANCOVA
Comparison: Week 12p-value: 0.474Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.011695% CI: [-34.13, 3.89]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.110995% CI: [-23.85, 14.26]Ranked ANCOVA
Secondary
Percent Change From Baseline in Fasting Serum TG
Time frame: Baseline, Weeks 2, 6, 10 and 12
Population: FAS Population. Missing values were imputed by LOCF.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in Fasting Serum TG | Week 2 | -27.46 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Fasting Serum TG | Week 6 | -38.63 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Fasting Serum TG | Week 10 | -49.90 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Fasting Serum TG | Week 12 | -41.88 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Fasting Serum TG | Week 12 | -36.01 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Fasting Serum TG | Week 2 | -27.10 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Fasting Serum TG | Week 10 | -32.83 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Fasting Serum TG | Week 6 | -25.11 Percent Change |
| Placebo | Percent Change From Baseline in Fasting Serum TG | Week 12 | -37.30 Percent Change |
| Placebo | Percent Change From Baseline in Fasting Serum TG | Week 6 | -22.18 Percent Change |
| Placebo | Percent Change From Baseline in Fasting Serum TG | Week 10 | -18.75 Percent Change |
| Placebo | Percent Change From Baseline in Fasting Serum TG | Week 2 | -27.07 Percent Change |
Comparison: Week 2p-value: 0.1663Ranked ANCOVA
Comparison: Week 2p-value: 0.6195Ranked ANCOVA
Comparison: Week 6p-value: 0.0436Ranked ANCOVA
Comparison: Week 6p-value: 0.5Ranked ANCOVA
Comparison: Week 10p-value: 0.0007Ranked ANCOVA
Comparison: Week 10p-value: 0.1161Ranked ANCOVA
Comparison: Week 12p-value: 0.183Ranked ANCOVA
Comparison: Week 12p-value: 0.8762Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in Fibrinogen | Week 12 | -1.8 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Fibrinogen | Week 10 | 1.2 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Fibrinogen | EOS | -0.2 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Fibrinogen | Week 12 | -11.4 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Fibrinogen | Week 10 | -6.7 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Fibrinogen | EOS | -8.4 Percent Change |
| Placebo | Percent Change From Baseline in Fibrinogen | Week 10 | -3.5 Percent Change |
| Placebo | Percent Change From Baseline in Fibrinogen | EOS | -3.1 Percent Change |
| Placebo | Percent Change From Baseline in Fibrinogen | Week 12 | -3.4 Percent Change |
Comparison: Week 10p-value: 0.1747Ranked ANCOVA
Comparison: Week 10p-value: 0.4576Ranked ANCOVA
Comparison: Week 12p-value: 0.1549Ranked ANCOVA
Comparison: Week 12p-value: 0.2427Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.137995% CI: [-6.26, 8.73]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.24995% CI: [-13.1, 0.51]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in HDL-C | Week 12 | 14.72 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in HDL-C | Week 10 | 5.87 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in HDL-C | Week 2 | 5.96 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in HDL-C | Week 6 | 5.33 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in HDL-C | EOS | 9.30 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in HDL-C | Week 10 | 7.14 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in HDL-C | Week 2 | 3.85 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in HDL-C | Week 6 | 7.42 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in HDL-C | Week 12 | 7.29 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in HDL-C | EOS | 7.04 Percent Change |
| Placebo | Percent Change From Baseline in HDL-C | EOS | 8.70 Percent Change |
| Placebo | Percent Change From Baseline in HDL-C | Week 12 | 7.69 Percent Change |
| Placebo | Percent Change From Baseline in HDL-C | Week 2 | 4.35 Percent Change |
| Placebo | Percent Change From Baseline in HDL-C | Week 10 | 10.34 Percent Change |
| Placebo | Percent Change From Baseline in HDL-C | Week 6 | 0.00 Percent Change |
Comparison: Week 2p-value: 0.1042Ranked ANCOVA
Comparison: Week 2p-value: 0.6204Ranked ANCOVA
Comparison: Week 6p-value: 0.8659Ranked ANCOVA
Comparison: Week 6p-value: 0.9658Ranked ANCOVA
Comparison: Week 10p-value: 0.8238Ranked ANCOVA
Comparison: Week 10p-value: 0.4874Ranked ANCOVA
Comparison: Week 12p-value: 0.9467Ranked ANCOVA
Comparison: Week 12p-value: 0.7467Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.908195% CI: [-10.77, 10.75]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.54895% CI: [-11.82, 6.86]Ranked ANCOVA
Secondary
Percent Change From Baseline in HDL Particle Number
Time frame: Baseline, Week 12
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in HDL Particle Number | -0.578 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in HDL Particle Number | 0.304 Percent Change |
| Placebo | Percent Change From Baseline in HDL Particle Number | 0.000 Percent Change |
p-value: 0.967295% CI: [-8.12, 9.07]Ranked ANCOVA
p-value: 0.799395% CI: [-5.31, 8.69]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in HDL-TG | Week 12 | -23.9 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in HDL-TG | Week 10 | -27.5 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in HDL-TG | EOS | -20.6 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in HDL-TG | Week 12 | -17.3 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in HDL-TG | Week 10 | -6.5 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in HDL-TG | EOS | -11.2 Percent Change |
| Placebo | Percent Change From Baseline in HDL-TG | Week 10 | -6.1 Percent Change |
| Placebo | Percent Change From Baseline in HDL-TG | EOS | -1.4 Percent Change |
| Placebo | Percent Change From Baseline in HDL-TG | Week 12 | -11.1 Percent Change |
Comparison: Week 10p-value: 0.0009Ranked ANCOVA
Comparison: Week 10p-value: 0.0351Ranked ANCOVA
Comparison: Week 12p-value: 0.1561Ranked ANCOVA
Comparison: Week 12p-value: 0.0268Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.051695% CI: [-42.96, -1.67]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.012595% CI: [-32.83, 4.88]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in High-sensitivity C-reactive Protein | Week 12 | -16.67 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in High-sensitivity C-reactive Protein | Week 10 | -33.33 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in High-sensitivity C-reactive Protein | EOS | -23.68 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in High-sensitivity C-reactive Protein | Week 12 | -25.48 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in High-sensitivity C-reactive Protein | Week 10 | -26.67 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in High-sensitivity C-reactive Protein | EOS | -16.94 Percent Change |
| Placebo | Percent Change From Baseline in High-sensitivity C-reactive Protein | Week 10 | -10.00 Percent Change |
| Placebo | Percent Change From Baseline in High-sensitivity C-reactive Protein | EOS | -0.71 Percent Change |
| Placebo | Percent Change From Baseline in High-sensitivity C-reactive Protein | Week 12 | 10.99 Percent Change |
Comparison: Week 10p-value: 0.0583Ranked ANCOVA
Comparison: Week 10p-value: 0.2289Ranked ANCOVA
Comparison: Week 12p-value: 0.0416Ranked ANCOVA
Comparison: Week 12p-value: 0.015Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.071895% CI: [-54.29, -1.26]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.124895% CI: [-50, 7.31]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in Interleukin-6 | Week 12 | -6.2 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Interleukin-6 | Week 10 | -7.7 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Interleukin-6 | EOS | -5.3 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Interleukin-6 | Week 12 | -7.5 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Interleukin-6 | Week 10 | -10.2 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Interleukin-6 | EOS | -4.8 Percent Change |
| Placebo | Percent Change From Baseline in Interleukin-6 | Week 10 | -1.1 Percent Change |
| Placebo | Percent Change From Baseline in Interleukin-6 | EOS | -4.2 Percent Change |
| Placebo | Percent Change From Baseline in Interleukin-6 | Week 12 | -10.6 Percent Change |
Comparison: Week 10p-value: 0.8823Ranked ANCOVA
Comparison: Week 10p-value: 0.3788Ranked ANCOVA
Comparison: Week 12p-value: 0.1091Ranked ANCOVA
Comparison: Week 12p-value: 0.6867Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.315695% CI: [-12.22, 36.34]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.973495% CI: [-24.58, 25.43]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in LDL-C | Week 12 | -7.94 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in LDL-C | Week 10 | -13.64 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in LDL-C | EOS | -13.36 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in LDL-C | Week 12 | 5.20 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in LDL-C | Week 10 | 4.39 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in LDL-C | EOS | 5.26 Percent Change |
| Placebo | Percent Change From Baseline in LDL-C | Week 10 | 0.00 Percent Change |
| Placebo | Percent Change From Baseline in LDL-C | EOS | 14.73 Percent Change |
| Placebo | Percent Change From Baseline in LDL-C | Week 12 | 25.43 Percent Change |
Comparison: Week 10p-value: 0.1512Ranked ANCOVA
Comparison: Week 10p-value: 0.84Ranked ANCOVA
Comparison: Week 12p-value: 0.0244Ranked ANCOVA
Comparison: Week 12p-value: 0.1803Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.030795% CI: [-42.73, -9.94]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.532695% CI: [-23.33, 7.68]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in LDL-TG | Week 12 | -17.5 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in LDL-TG | Week 10 | -17.1 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in LDL-TG | EOS | -20.0 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in LDL-TG | Week 12 | -7.2 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in LDL-TG | Week 10 | -12.2 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in LDL-TG | EOS | -9.3 Percent Change |
| Placebo | Percent Change From Baseline in LDL-TG | Week 10 | 0.8 Percent Change |
| Placebo | Percent Change From Baseline in LDL-TG | EOS | -6.8 Percent Change |
| Placebo | Percent Change From Baseline in LDL-TG | Week 12 | -6.0 Percent Change |
Comparison: Week 10p-value: 0.0298Ranked ANCOVA
Comparison: Week 10p-value: 0.0196Ranked ANCOVA
Comparison: Week 12p-value: 0.2219Ranked ANCOVA
Comparison: Week 12p-value: 0.4078Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.060595% CI: [-31.68, 1.3]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.176895% CI: [-19.91, 7.32]Ranked ANCOVA
Secondary
Percent Change From Baseline in Lipoprotein Particle Number
Percent change from baseline in particle number for VLDL & chylomicron, LDL and IDL were reported.
Time frame: Baseline, Week 12
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in Lipoprotein Particle Number | LDL Particles | -9.83 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Lipoprotein Particle Number | VLDL and Chylomicron Particles | -15.82 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Lipoprotein Particle Number | IDL Particles | -73.1 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Lipoprotein Particle Number | LDL Particles | -10.20 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Lipoprotein Particle Number | VLDL and Chylomicron Particles | -3.88 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Lipoprotein Particle Number | IDL Particles | -2.2 Percent Change |
| Placebo | Percent Change From Baseline in Lipoprotein Particle Number | VLDL and Chylomicron Particles | -4.03 Percent Change |
| Placebo | Percent Change From Baseline in Lipoprotein Particle Number | IDL Particles | 16.7 Percent Change |
| Placebo | Percent Change From Baseline in Lipoprotein Particle Number | LDL Particles | 13.96 Percent Change |
Comparison: VLDL \& Chylomicron particlesp-value: 0.078195% CI: [-33.76, 2.55]Ranked ANCOVA
Comparison: VLDL \& Chylomicron particlesp-value: 0.990195% CI: [-19.36, 19.01]Ranked ANCOVA
Comparison: LDL Particlesp-value: 0.071795% CI: [-43.62, -5.1]Ranked ANCOVA
Comparison: LDL Particlesp-value: 0.154895% CI: [-36.78, 3.76]Ranked ANCOVA
Comparison: IDL Particlesp-value: 0.042895% CI: [-119.58, -5.78]Ranked ANCOVA
Comparison: IDL Particlesp-value: 0.183695% CI: [-121.44, 19.48]Ranked ANCOVA
Secondary
Percent Change From Baseline in Lipoprotein Size
Percent change from baseline in Particle size for VLDL, HDL and LDL were reported.
Time frame: Baseline, Week 12
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in Lipoprotein Size | LDL | 0.00 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Lipoprotein Size | VLDL | -7.83 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Lipoprotein Size | HDL | 0.000 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Lipoprotein Size | LDL | 0.00 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Lipoprotein Size | VLDL | -6.36 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Lipoprotein Size | HDL | 0.000 Percent Change |
| Placebo | Percent Change From Baseline in Lipoprotein Size | VLDL | -5.17 Percent Change |
| Placebo | Percent Change From Baseline in Lipoprotein Size | HDL | 0.000 Percent Change |
| Placebo | Percent Change From Baseline in Lipoprotein Size | LDL | 0.51 Percent Change |
Comparison: VLDLp-value: 0.263295% CI: [-10.17, 5.67]Ranked ANCOVA
Comparison: VLDLp-value: 0.538295% CI: [-6.77, 9.71]Ranked ANCOVA
Comparison: LDLp-value: 0.172795% CI: [-0.51, 1.01]Ranked ANCOVA
Comparison: LDLp-value: 0.456795% CI: [-0.51, 0.51]Ranked ANCOVA
Comparison: HDLp-value: 0.614295% CI: [-1.21, 1.47]Ranked ANCOVA
Comparison: HDLp-value: 0.240995% CI: [-2.23, 1.29]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in Non-HDL-C | Week 12 | -13.31 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Non-HDL-C | Week 10 | -22.18 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Non-HDL-C | Week 2 | -13.92 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Non-HDL-C | Week 6 | -22.57 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Non-HDL-C | EOS | -15.64 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Non-HDL-C | Week 10 | -11.18 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Non-HDL-C | Week 2 | -6.35 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Non-HDL-C | Week 6 | -10.55 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Non-HDL-C | Week 12 | -9.92 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Non-HDL-C | EOS | -12.01 Percent Change |
| Placebo | Percent Change From Baseline in Non-HDL-C | EOS | -3.98 Percent Change |
| Placebo | Percent Change From Baseline in Non-HDL-C | Week 12 | -10.56 Percent Change |
| Placebo | Percent Change From Baseline in Non-HDL-C | Week 2 | -3.29 Percent Change |
| Placebo | Percent Change From Baseline in Non-HDL-C | Week 10 | -7.66 Percent Change |
| Placebo | Percent Change From Baseline in Non-HDL-C | Week 6 | -7.77 Percent Change |
Comparison: Week 2p-value: 0.0277Ranked ANCOVA
Comparison: Week 2p-value: 0.2502Ranked ANCOVA
Comparison: Week 6p-value: 0.0161Ranked ANCOVA
Comparison: Week 6p-value: 0.6567Ranked ANCOVA
Comparison: Week 10p-value: 0.001Ranked ANCOVA
Comparison: Week 10p-value: 0.1257Ranked ANCOVA
Comparison: Week 12p-value: 0.144Ranked ANCOVA
Comparison: Week 12p-value: 0.7642Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.010795% CI: [-28.31, -4.51]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.246695% CI: [-16.73, 5.52]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in Serum Amyloid A | Week 12 | -36.7 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Serum Amyloid A | Week 10 | -33.3 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in Serum Amyloid A | EOS | -31.8 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Serum Amyloid A | Week 12 | -29.2 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Serum Amyloid A | Week 10 | -19.2 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in Serum Amyloid A | EOS | -19.6 Percent Change |
| Placebo | Percent Change From Baseline in Serum Amyloid A | Week 10 | -12.5 Percent Change |
| Placebo | Percent Change From Baseline in Serum Amyloid A | EOS | -7.2 Percent Change |
| Placebo | Percent Change From Baseline in Serum Amyloid A | Week 12 | -7.2 Percent Change |
Comparison: Week 10p-value: 0.0679Ranked ANCOVA
Comparison: Week 10p-value: 0.4126Ranked ANCOVA
Comparison: Week 12p-value: 0.0095Ranked ANCOVA
Comparison: Week 12p-value: 0.0172Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.035995% CI: [-41.54, -3.64]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.081295% CI: [-38.62, 5.61]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in TC | Week 12 | -10.25 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in TC | Week 10 | -17.23 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in TC | Week 2 | -12.67 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in TC | Week 6 | -17.00 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in TC | EOS | -13.65 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in TC | Week 10 | -8.44 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in TC | Week 2 | -4.48 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in TC | Week 6 | -8.68 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in TC | Week 12 | -8.62 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in TC | EOS | -7.28 Percent Change |
| Placebo | Percent Change From Baseline in TC | EOS | -2.82 Percent Change |
| Placebo | Percent Change From Baseline in TC | Week 12 | -6.93 Percent Change |
| Placebo | Percent Change From Baseline in TC | Week 2 | -2.67 Percent Change |
| Placebo | Percent Change From Baseline in TC | Week 10 | -2.42 Percent Change |
| Placebo | Percent Change From Baseline in TC | Week 6 | -6.12 Percent Change |
Comparison: Week 2p-value: 0.0391Ranked ANCOVA
Comparison: Week 2p-value: 0.2455Ranked ANCOVA
Comparison: Week 6p-value: 0.026Ranked ANCOVA
Comparison: Week 6p-value: 0.5704Ranked ANCOVA
Comparison: Week 10p-value: 0.0009Ranked ANCOVA
Comparison: Week 10p-value: 0.0846Ranked ANCOVA
Comparison: Week 12p-value: 0.1763Ranked ANCOVA
Comparison: Week 12p-value: 0.5576Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.008695% CI: [-24.68, -4.39]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.151695% CI: [-15.02, 3.64]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, Number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in VLDL-C | Week 12 | -31.34 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in VLDL-C | Week 10 | -32.71 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in VLDL-C | Week 2 | -46.19 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in VLDL-C | Week 6 | -36.41 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in VLDL-C | EOS | -31.95 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in VLDL-C | Week 10 | -16.67 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in VLDL-C | Week 2 | -46.27 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in VLDL-C | Week 6 | -43.31 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in VLDL-C | Week 12 | -19.14 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in VLDL-C | EOS | -15.95 Percent Change |
| Placebo | Percent Change From Baseline in VLDL-C | EOS | -17.57 Percent Change |
| Placebo | Percent Change From Baseline in VLDL-C | Week 12 | -31.69 Percent Change |
| Placebo | Percent Change From Baseline in VLDL-C | Week 2 | -29.59 Percent Change |
| Placebo | Percent Change From Baseline in VLDL-C | Week 10 | -7.85 Percent Change |
| Placebo | Percent Change From Baseline in VLDL-C | Week 6 | -33.50 Percent Change |
Comparison: Week 2p-value: 0.638Ranked ANCOVA
Comparison: Week 2p-value: 0.2395Ranked ANCOVA
Comparison: Week 6p-value: 0.7468Ranked ANCOVA
Comparison: Week 6p-value: 0.8483Ranked ANCOVA
Comparison: Week 10p-value: 0.0008Ranked ANCOVA
Comparison: Week 10p-value: 0.0938Ranked ANCOVA
Comparison: Week 12p-value: 0.3201Ranked ANCOVA
Comparison: Week 12p-value: 0.901Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.015695% CI: [-39.06, -1.49]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.345695% CI: [-28.51, 17.26]Ranked ANCOVA
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.
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcabene 600 mg | Percent Change From Baseline in VLDL-TG | Week 12 | -34.8 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in VLDL-TG | Week 10 | -39.7 Percent Change |
| Gemcabene 600 mg | Percent Change From Baseline in VLDL-TG | EOS | -35.2 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in VLDL-TG | Week 12 | -27.0 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in VLDL-TG | Week 10 | -32.8 Percent Change |
| Gemcabene 300 mg | Percent Change From Baseline in VLDL-TG | EOS | -30.8 Percent Change |
| Placebo | Percent Change From Baseline in VLDL-TG | Week 10 | -11.0 Percent Change |
| Placebo | Percent Change From Baseline in VLDL-TG | EOS | -23.9 Percent Change |
| Placebo | Percent Change From Baseline in VLDL-TG | Week 12 | -37.3 Percent Change |
Comparison: Week 10p-value: 0.0037Ranked ANCOVA
Comparison: Week 10p-value: 0.1328Ranked ANCOVA
Comparison: Week 12p-value: 0.4364Ranked ANCOVA
Comparison: Week 12p-value: 0.8129Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.034795% CI: [-36.54, 2.35]Ranked ANCOVA
Comparison: EOS (average of week 10 and 12)p-value: 0.361795% CI: [-25.78, 23.62]Ranked ANCOVA