Clinical Trial Details

Trial ID: L0127
Source ID: NCT03371355
Associated Drug: ISIS 703802
Title: Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease
Acronym: --
Status: Completed
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT03371355/results
Conditions: NAFLD|Diabetes Mellitus, Type 2|Hypertriglyceridemia|Fatty Liver, Nonalcoholic
Interventions: Drug: Placebo|Drug: ISIS 703802 40 mg|Drug: ISIS 703802 80 mg|Drug: ISIS 703802 20 mg
Outcome Measures: Percent Change From Baseline in Fasting Triglycerides Level at the Primary Analysis Time Point|Change From Baseline in Angiopoietin-Like 3 Protein at the Primary Analysis Time Point|Change From Baseline in TC, LDL-C, HDL-C, VLDL-C, Non-HDL-C, ApoB (ApoB-48, ApoB-100), ApoCIII, and ApoAI at the Primary Analysis Time Point|Change From Baseline in Free Fatty Acid (FFA) at Primary Analysis Time Point|Change From Baseline in Lipoprotein(a) (Lp[a]) at the Primary Analysis Time Point|Percent Change From Baseline in ANGPTL3, TC, LDL-C, HDL-C, VLDL-C, Non-HDL-C, ApoB (ApoB-48, ApoB-100), ApoCIII, ApoAI, FFA, and Lp(a) at Primary Analysis Time Point|Change From Baseline in Fasting Plasma Glucose at the Primary Analysis Time Point|Change From Baseline in Hemoglobin A1c (HbA1c) at the Primary Analysis Time Point|Change From Baseline in Fasting Insulin at the Primary Analysis Time Point|Change From Baseline in and HOMA-IR at the Primary Analysis Time Point|Change From Baseline in Fructosamine at Primary Analysis Time Point|Change From Baseline in Glycated Albumin at the Primary Analysis Time Point|Change From Baseline in Weight at the Primary Analysis Time Point|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Primary Analysis Time Point|Percent Change From Baseline in Weight, SBP and DBP at Primary Analysis Time Point|Change From Baseline in Hepatic Fat Fraction (HFF) by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at the Primary Analysis Time Point|Percent Change From Baseline in Hepatic Fat Fraction (HFF) by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at the Primary Analysis Time Point|Percentage of Participants With HFF ??? 8% by MRI-PDFF at the Primary Analysis Time Point|Change From Baseline in Fatty Liver Index (FLI) at the Primary Analysis Time Point|Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at the Primary Analysis Time Point|Change From Baseline in Leptin at the Primary Analysis Time Point|Change From Baseline in Adiponectin at the Primary Analysis Time Point|Change From Baseline in Subcutaneous Adipose Tissue (SAT) and Visceral Adipose Tissue (VAT) by Single Slice MRI at the Primary Analysis Timepoint|Change From Baseline in Waist Circumference by Single Slice MRI at the Primary Analysis Timepoint|Change From Baseline in Waist to Hip Ratio (WHR) at the Primary Analysis Timepoint|Change From Baseline in Body Mass Index (BMI) at the Primary Analysis Timepoint|Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Sponsor/Collaborators: Akcea Therapeutics|Ionis Pharmaceuticals, Inc.
Gender: All
Age: 18 Years to 70 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 105
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: December 21, 2017
Completion Date: February 24, 2020
Results First Posted: February 1, 2021
Last Update Posted: February 1, 2021
Locations: Clinical Sites, Chandler, Arizona, United States|Clinical Site, Fountain Hills, Arizona, United States|Clinical Site, Glendale, Arizona, United States|Clinical Site, Mesa, Arizona, United States|Clinical Site, Mesa, Arizona, United States|Clinical Site, Phoenix, Arizona, United States|Clinical Site, Phoenix, Arizona, United States|Clinical Site, Phoenix, Arizona, United States|Clinical Site, Huntington Park, California, United States|Clinical Site, Los Angeles, California, United States|Clinical Site, Montclair, California, United States|Clinical Site, Panorama City, California, United States|Clinical Site, Poway, California, United States|Clinical Site, Boca Raton, Florida, United States|Clinical Site, Jensen Beach, Florida, United States|Clinical Site, Jupiter, Florida, United States|Clinical Site, Miami, Florida, United States|Clinical Site, Port Saint Lucie, Florida, United States|Clinical Site, Atlanta, Georgia, United States|Clinical Site, Chicago, Illinois, United States|Clinical Site, Indianapolis, Indiana, United States|Clinical Site, Louisville, Kentucky, United States|Clinical Site, Edina, Minnesota, United States|Clinical Site, Bridgeton, New Jersey, United States|Clinical Site, Princeton, New Jersey, United States|Clinical Site, Greensboro, North Carolina, United States|Clinical Site, High Point, North Carolina, United States|Clinical Site, Cincinnati, Ohio, United States|Clinical Site, Cincinnati, Ohio, United States|Clinical Site, Charleston, South Carolina, United States|Clinical Site, Austin, Texas, United States|Clinical Site, Carrollton, Texas, United States|Clinical Site, Dallas, Texas, United States|Clinical Site, Houston, Texas, United States|Clinical Site, Hurst, Texas, United States|Clinical Site, San Antonio, Texas, United States|Clinical Site, San Antonio, Texas, United States|Clinical Site, Layton, Utah, United States|Clinical Site, Hamilton, Ontario, Canada|Clinical Site, Toronto, Ontario, Canada|Clinical Site, Chicoutimi, Quebec, Canada|Clinical Site, Montr??al, Quebec, Canada
URL: https://ClinicalTrials.gov/show/NCT03371355

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D188 ISIS 703802 Biological drug -- -- Anticholesteremic drug Under clinical trials Details
D182 Insulin Biological drug DB00030 INSR agonist; CPE modulator&product of -- Under clinical trials Details
D199 L-alanine Chemical drug DB00160 KYNU -- Failed in clinical trials Details
D316 S-adenosyl-L-methionine Chemical drug DB00118 GNMT cofactor Antiviral Under clinical trials Details