| Outcome Measures: |
Primary: Absolute Change in Liver Fat Percentage (Randomized Population), Absolute change in liver fat percentage as quantified by magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF) from baseline to post-treatment MRI., Baseline to Week 15|Absolute Change in Liver Fat Percentage (Per Protocol Population), Absolute change in liver fat percentage as quantified by MRI-PDFF from baseline to post-treatment MRI., Baseline to Week 15|Percentage of Participants With Adverse Events That Were Related to Treatment With IONIS DGAT2Rx, An adverse event (AE) is any unfavorable and unintended sign (including a clinically-significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product., Up to 176 days|Percentage of Participants With Adverse Events, Graded by Severity, That Were Related to Treatment With IONIS DGAT2Rx, AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, June 2010. Grades: mild - the event is easily tolerated by the participant and does not affect the participant's usual daily activities; moderate - the event causes the participant more discomfort and interrupts the participant's usual daily activities; severe - the event is incapacitating and causes considerable interference with the participant's usual daily activities., Up to 176 days | Secondary: Percent Change in Liver Fat Percentage, Relative percent change in liver fat percentage from baseline to post-treatment MRI., Baseline to Week 15|Percentage of Participants With ≥ 30% Relative Reduction in Liver Fat Percentage, Percentage of participants with ≥ 30% relative reduction in liver fat percentage from baseline to post-treatment., Week 15|Percent Change in Liver Volume, Assessed from Baseline MRI to Post-Treatment MRI., Baseline to Week 15|Percent Change in Plasma Lipoprotein Profile, Percent change in plasma lipoprotein profile (total cholesterol, apolipoprotein B \[ApoB\], high density lipoprotein (HDL), low density lipoprotein cholesterol \[LDL-C\], non-HDL, triglycerides, and very low density lipoproteins \[VLDL\]) from baseline to the average of the post-treatment values assessed 1 and 2 weeks after the last dose (Post-Treatment 1 and Post-Treatment 2 visits)., Week 15|Percent Change in Parameters of Insulin Resistance (IR), Percent change in parameters of IR (fasting plasma glucose \[FPG\], homeostatic model assessment - insulin resistance \[HOMA-IR\], and insulin) from baseline to post-treatment., Week 14|Absolute Change in Hemoglobin A1C (HbA1C), Absolute change in HbA1C from baseline to post-treatment., Week 14
|
| Locations: |
Ionis Investigational Site, Halifax, Nova Scotia, B3H 2Y9, Canada|Ionis Investigational Site, Chicoutimi, Quebec, G7H 7K9, Canada|Ionis Investigational Site, Budapest, 1036, Hungary|Ionis Investigational Site, Budapest, 1083, Hungary|Ionis Investigational Site, Budapest, 1088, Hungary|Ionis Investigational Site, Hatvan, 3000, Hungary|Ionis Investigational Site, Miskolc, 3529, Hungary|Ionis Investigational Site, Szekesfehervar, 8000, Hungary|Ionis Investigational Site, Bydgoszcz, 85-863, Poland|Ionis Investigational Site, Bytom, 41-902, Poland|Ionis Investigational Site, Chełm, 22-100, Poland|Ionis Investigational Site, Katowice, 40-752, Poland|Ionis Investigational Site, Kraków, 31-501, Poland|Ionis Investigational Site, Kraków, 31-530, Poland|Ionis Investigational Site, Mysłowice, 41-400, Poland|Ionis Investigational Site, Wierzchosławice, 33-122, Poland|Ionis Investigational Site, Wrocław, 50-127, Poland|Ionis Investigational Site, Wrocław, 50-220, Poland|Ionis Investigational Site, Wrocław, 50-349, Poland|Ionis Investigational Site, Łódź, 93-509, Poland|Ionis Investigational Site, Dundee, DD1 9SY, United Kingdom|Ionis Investigational Site, Nottingham, NG7 2UH, United Kingdom
|
