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Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease

Primary Purpose

NAFLD, Diabetes Mellitus, Type 2, Hypertriglyceridemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
ISIS 703802 40 mg
ISIS 703802 80 mg
ISIS 703802 20 mg
Sponsored by
Akcea Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD focused on measuring Type 2 Diabetes, Hepatic Steatosis, Triglycerides, AKCEA-ANGPTL3-Lrx, IONIS-ANGPTL3-Lrx, Fatty Liver, Fatty Liver Without Mention of Alcohol, Liver Fat, Liver Diseases, Diabetes Mellitus Type 2 in Nonobese, Diabetes Mellitus, Triglycerides High, High Triglycerides, Metabolic Disease, Endocrine System Diseases, Digestive System Disease, Glucose Metabolism Disorders, Vupanorsen

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Plasma triglycerides (TG) at Screening greater than (>)150 milligrams per deciliter (mg/dL) and at qualification of >150 mg/dL.
  • Documented history of hepatic steatosis with baseline magnetic resonance imaging (MRI) indicating hepatic fat fraction (HFF) greater than (>) 8%.
  • Diagnosis of Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) >6.5 and less than or equal to (≤) 10% at Screening.
  • Must have been on a stable dose of oral antidiabetic therapy for a minimum of 3 months prior to Screening.
  • Body mass index between 27- 40 kilograms per meter square (kg/m^2), inclusive, at Screening.

Key Exclusion Criteria:

  • Type 1 diabetes mellitus.
  • Active chronic liver disease, alcoholic liver disease, Wilson's disease hemochromatosis, primary biliary cirrhosis, primary sclerosing cholangitis, genetic hemochromatosis, known or suspected hepatocellular carcinoma, history of or planned liver transplant for end-stage liver disease of any etiology.
  • Documented history of advanced liver fibrosis.
  • History of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy, or variceal bleeding.
  • History of clinically significant acute cardiac event within 6 months before Screening.
  • History of heart failure with New York Heart Association (NYHA) greater than Class II.
  • Use of Insulin or insulin analogs, glucagon-like peptide-1 (GLP-1) agonists, and peroxisome proliferator-activated receptor gamma (PPARᵞ) agonists (pioglitazone or rosiglitazone).
  • Weight change >5% within 3 months before Screening.
  • Conditions contraindicated for magnetic resonance imaging (MRI) procedures including any metal implant (example, heart pacemaker, rods, screws, aneurysm clips).

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Pooled Placebo

Cohort B: ISIS 703802, 40 mg Q4W

Cohort C: ISIS 703802, 80 mg Q4W

Cohort A: ISIS 703802, 20 mg QW

Arm Description

Participants from each cohort received placebo at a dose-matched volume of study drug, subcutaneously (SC).

Participants received ISIS 703802, 40 milligrams (mg) SC once every 4 weeks for 6 doses.

Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses.

Participants received ISIS 703802, 20 mg once every week for 26 doses.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Fasting Triglycerides Level at the Primary Analysis Time Point
An ANCOVA model was performed on the log ratio of Primary Analysis Time Point to Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of Primary Analysis Time Point to Baseline - 1) × 100.

Secondary Outcome Measures

Change From Baseline in Angiopoietin-Like 3 Protein at the Primary Analysis Time Point
An ANCOVA model was performed on the change from Baseline to 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
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Change From Baseline in Free Fatty Acid (FFA) at Primary Analysis Time Point
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Change From Baseline in Lipoprotein(a) (Lp[a]) at the Primary Analysis Time Point
An ANCOVA model was performed on the change from Baseline to 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
An ANCOVA model was performed on the log ratio of Primary Analysis Time Point to Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of Primary Analysis Time Point to Baseline - 1) × 100.
Change From Baseline in Fasting Plasma Glucose at the Primary Analysis Time Point
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Change From Baseline in Hemoglobin A1c (HbA1c) at the Primary Analysis Time Point
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Change From Baseline in Fasting Insulin at the Primary Analysis Time Point
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Change From Baseline in and HOMA-IR at the Primary Analysis Time Point
HOMA-IR is a method used to quantify insulin resistance. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/mL) * fasting plasma glucose (mmol/L)/22.5. A negative change from Baseline indicates improvement. An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Change From Baseline in Fructosamine at Primary Analysis Time Point
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Change From Baseline in Glycated Albumin at the Primary Analysis Time Point
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Change From Baseline in Weight at the Primary Analysis Time Point
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Primary Analysis Time Point
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Percent Change From Baseline in Weight, SBP and DBP at Primary Analysis Time Point
An ANCOVA model was performed on the percent change from Baseline to 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
An ANCOVA model was performed on the change from Baseline to 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
An ANCOVA model was performed on the percent change from Baseline to Primary Analysis Time Point.
Percentage of Participants With HFF ≤ 8% by MRI-PDFF at the Primary Analysis Time Point
The percentage of participants who achieved HFF ≤ 8% at the Primary Analysis Time Point was compared between each ISIS 703802 treatment group and pooled placebo group using a logistic regression model.
Change From Baseline in Fatty Liver Index (FLI) at the Primary Analysis Time Point
The FLI was calculated by the following formula: FLI =(e0.953×loge[triglycerides]+0.139× Body Mass Index [BMI]+0.718×loge Gamma- Glutamyl Transferase [GGT]+0.053×waistcircumference-15.745)/ (1 + e0.953×loge[triglycerides]+0.139×BMI+0.718×loge [GGT]+0.053×waistcircumference-15.745) × 100. An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at the Primary Analysis Time Point
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Change From Baseline in Leptin at the Primary Analysis Time Point
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Change From Baseline in Adiponectin at the Primary Analysis Time Point
An ANCOVA model was performed on the change from Baseline to 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
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Change From Baseline in Waist Circumference by Single Slice MRI at the Primary Analysis Timepoint
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Change From Baseline in Waist to Hip Ratio (WHR) at the Primary Analysis Timepoint
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Change From Baseline in Body Mass Index (BMI) at the Primary Analysis Timepoint
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An AE was defined as 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 was considered related to the investigational drug product. TEAEs were defined as adverse events that occurred after the first administration of study drug.

Full Information

First Posted
November 27, 2017
Last Updated
January 28, 2021
Sponsor
Akcea Therapeutics
Collaborators
Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03371355
Brief Title
Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study of ISIS 703802 (AKCEA-ANGPTL3-LRx) Administered Subcutaneously to Subjects With Hypertriglyceridemia, Type 2 Diabetes Mellitus (T2DM), and Nonalcoholic Fatty Liver Disease (NAFLD)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
November 21, 2019 (Actual)
Study Completion Date
February 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akcea Therapeutics
Collaborators
Ionis Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 703802 and to assess the efficacy of different doses and dosing regimens of ISIS 703802 on glucose and lipid metabolism, and liver fat in participants with hypertriglyceridemia, Type 2 diabetes mellitus (T2DM), and nonalcoholic fatty liver disease (NAFLD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD, Diabetes Mellitus, Type 2, Hypertriglyceridemia, Fatty Liver, Nonalcoholic
Keywords
Type 2 Diabetes, Hepatic Steatosis, Triglycerides, AKCEA-ANGPTL3-Lrx, IONIS-ANGPTL3-Lrx, Fatty Liver, Fatty Liver Without Mention of Alcohol, Liver Fat, Liver Diseases, Diabetes Mellitus Type 2 in Nonobese, Diabetes Mellitus, Triglycerides High, High Triglycerides, Metabolic Disease, Endocrine System Diseases, Digestive System Disease, Glucose Metabolism Disorders, Vupanorsen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pooled Placebo
Arm Type
Placebo Comparator
Arm Description
Participants from each cohort received placebo at a dose-matched volume of study drug, subcutaneously (SC).
Arm Title
Cohort B: ISIS 703802, 40 mg Q4W
Arm Type
Experimental
Arm Description
Participants received ISIS 703802, 40 milligrams (mg) SC once every 4 weeks for 6 doses.
Arm Title
Cohort C: ISIS 703802, 80 mg Q4W
Arm Type
Experimental
Arm Description
Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses.
Arm Title
Cohort A: ISIS 703802, 20 mg QW
Arm Type
Experimental
Arm Description
Participants received ISIS 703802, 20 mg once every week for 26 doses.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sterile Normal Saline (0.9% NaCl)
Intervention Description
Placebo (Matched with ISIS 703802)
Intervention Type
Drug
Intervention Name(s)
ISIS 703802 40 mg
Other Intervention Name(s)
AKCEA-ANGPTL3-LRx, IONIS-ANGPTL3-LRx, Vupanorsen
Intervention Description
ISIS 703802 40 mg, administered via SC injection, once every 4 weeks for 6 doses.
Intervention Type
Drug
Intervention Name(s)
ISIS 703802 80 mg
Other Intervention Name(s)
AKCEA-ANGPTL3-LRx, IONIS-ANGPTL3-LRx, Vupanorsen
Intervention Description
ISIS 703802 80 mg, administered via SC injection, once every 4 weeks for 6 doses.
Intervention Type
Drug
Intervention Name(s)
ISIS 703802 20 mg
Other Intervention Name(s)
AKCEA-ANGPTL3-LRx, IONIS-ANGPTL3-LRx, Vupanorsen
Intervention Description
ISIS 703802 20 mg, administered via SC injection, once every week for 26 doses.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Fasting Triglycerides Level at the Primary Analysis Time Point
Description
An ANCOVA model was performed on the log ratio of Primary Analysis Time Point to Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of Primary Analysis Time Point to Baseline - 1) × 100.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Secondary Outcome Measure Information:
Title
Change From Baseline in Angiopoietin-Like 3 Protein at the Primary Analysis Time Point
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
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
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Free Fatty Acid (FFA) at Primary Analysis Time Point
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Lipoprotein(a) (Lp[a]) at the Primary Analysis Time Point
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
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
Description
An ANCOVA model was performed on the log ratio of Primary Analysis Time Point to Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of Primary Analysis Time Point to Baseline - 1) × 100.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Fasting Plasma Glucose at the Primary Analysis Time Point
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Hemoglobin A1c (HbA1c) at the Primary Analysis Time Point
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Fasting Insulin at the Primary Analysis Time Point
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in and HOMA-IR at the Primary Analysis Time Point
Description
HOMA-IR is a method used to quantify insulin resistance. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/mL) * fasting plasma glucose (mmol/L)/22.5. A negative change from Baseline indicates improvement. An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Fructosamine at Primary Analysis Time Point
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Glycated Albumin at the Primary Analysis Time Point
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Weight at the Primary Analysis Time Point
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Primary Analysis Time Point
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Percent Change From Baseline in Weight, SBP and DBP at Primary Analysis Time Point
Description
An ANCOVA model was performed on the percent change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C6
Title
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
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
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
Description
An ANCOVA model was performed on the percent change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Percentage of Participants With HFF ≤ 8% by MRI-PDFF at the Primary Analysis Time Point
Description
The percentage of participants who achieved HFF ≤ 8% at the Primary Analysis Time Point was compared between each ISIS 703802 treatment group and pooled placebo group using a logistic regression model.
Time Frame
Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Fatty Liver Index (FLI) at the Primary Analysis Time Point
Description
The FLI was calculated by the following formula: FLI =(e0.953×loge[triglycerides]+0.139× Body Mass Index [BMI]+0.718×loge Gamma- Glutamyl Transferase [GGT]+0.053×waistcircumference-15.745)/ (1 + e0.953×loge[triglycerides]+0.139×BMI+0.718×loge [GGT]+0.053×waistcircumference-15.745) × 100. An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at the Primary Analysis Time Point
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Leptin at the Primary Analysis Time Point
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Adiponectin at the Primary Analysis Time Point
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Subcutaneous Adipose Tissue (SAT) and Visceral Adipose Tissue (VAT) by Single Slice MRI at the Primary Analysis Timepoint
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Waist Circumference by Single Slice MRI at the Primary Analysis Timepoint
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Waist to Hip Ratio (WHR) at the Primary Analysis Timepoint
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Change From Baseline in Body Mass Index (BMI) at the Primary Analysis Timepoint
Description
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Time Frame
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
An AE was defined as 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 was considered related to the investigational drug product. TEAEs were defined as adverse events that occurred after the first administration of study drug.
Time Frame
Up to 13 weeks post treatment period (up to 39 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Plasma triglycerides (TG) at Screening greater than (>)150 milligrams per deciliter (mg/dL) and at qualification of >150 mg/dL. Documented history of hepatic steatosis with baseline magnetic resonance imaging (MRI) indicating hepatic fat fraction (HFF) greater than (>) 8%. Diagnosis of Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) >6.5 and less than or equal to (≤) 10% at Screening. Must have been on a stable dose of oral antidiabetic therapy for a minimum of 3 months prior to Screening. Body mass index between 27- 40 kilograms per meter square (kg/m^2), inclusive, at Screening. Key Exclusion Criteria: Type 1 diabetes mellitus. Active chronic liver disease, alcoholic liver disease, Wilson's disease hemochromatosis, primary biliary cirrhosis, primary sclerosing cholangitis, genetic hemochromatosis, known or suspected hepatocellular carcinoma, history of or planned liver transplant for end-stage liver disease of any etiology. Documented history of advanced liver fibrosis. History of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy, or variceal bleeding. History of clinically significant acute cardiac event within 6 months before Screening. History of heart failure with New York Heart Association (NYHA) greater than Class II. Use of Insulin or insulin analogs, glucagon-like peptide-1 (GLP-1) agonists, and peroxisome proliferator-activated receptor gamma (PPARᵞ) agonists (pioglitazone or rosiglitazone). Weight change >5% within 3 months before Screening. Conditions contraindicated for magnetic resonance imaging (MRI) procedures including any metal implant (example, heart pacemaker, rods, screws, aneurysm clips).
Facility Information:
Facility Name
Clinical Sites
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Clinical Site
City
Fountain Hills
State/Province
Arizona
ZIP/Postal Code
85268
Country
United States
Facility Name
Clinical Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Clinical Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Clinical Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Clinical Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Clinical Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Clinical Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Clinical Site
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Clinical Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Clinical Site
City
Montclair
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Clinical Site
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Clinical Site
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Clinical Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Clinical Site
City
Jensen Beach
State/Province
Florida
ZIP/Postal Code
34957
Country
United States
Facility Name
Clinical Site
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Clinical Site
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Clinical Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Clinical Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Clinical Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Clinical Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Clinical Site
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Clinical Site
City
Bridgeton
State/Province
New Jersey
ZIP/Postal Code
08302
Country
United States
Facility Name
Clinical Site
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Clinical Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
Clinical Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27265
Country
United States
Facility Name
Clinical Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Clinical Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Clinical Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Clinical Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78735
Country
United States
Facility Name
Clinical Site
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
Clinical Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Clinical Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Clinical Site
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Clinical Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Clinical Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Site
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Clinical Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G8
Country
Canada
Facility Name
Clinical Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3M 3E5
Country
Canada
Facility Name
Clinical Site
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Clinical Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 2C6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease

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