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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02709850
Other study ID # ISIS 703802-CS1
Secondary ID 2015-004003-23
Status Completed
Phase Phase 1
First received
Last updated
Start date November 30, 2015
Est. completion date June 26, 2017

Study information

Verified date November 2020
Source Ionis Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS ANGPTL3-LRx (ISIS 703802) given to healthy volunteer subjects with elevated triglycerides and subjects with familial hypercholesterolemia.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date June 26, 2017
Est. primary completion date April 12, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria for All Cohorts: - Must have given written informed consent and be able to comply with all study requirements - Males or females 18 to 65 years, inclusive, at the time of informed consent - Body Mass Index (BMI) = 35.0 kg/m2 - Females must be non-pregnant and non-lactating, and either surgically sterile or postmenopausal. - Males must be surgically sterile, abstinent or using an acceptable contraceptive method Inclusion criteria for Cohorts, A, D, and AA to DD only: - Fasting triglycerides (TG) = 150 mg/dL at Screening - Fasting low density lipoprotein cholesterol (LDL-C) > 70 mg/dL at Screening Inclusion criteria for Cohorts B and C only: - Fasting TG 90 - 150 mg/dL at Screening - Fasting LDL-C > 70 mg/dL at Screening Inclusion Criteria for Cohort EE Only: - Homozygous FH diagnosis and fasting LDL-C = 190 mg/dL (4.9 mmol/L) Inclusion Criteria for Cohort FF Only: - Heterozygous FH diagnosis and fasting LDL-C = 160 mg/dL (4.1 mmol/L) Inclusion Criteria for Cohorts EE and FF Only: - Maximally tolerated stable LDL-C lowering agents (stable for at least 12 weeks) - On stable low-fat diet - Stable weight (± 4 kg) for = 6 weeks prior to screening Exclusion Criteria for All Cohorts: - Known history or positive test for Human Immunodeficiency Virus (HIV), Hepatitis C (HCV), or Hepatitis B (HBV) - Treatment with another Study Drug, biological agent, or device within one-month or 5-half-lives of screening - Regular use of alcohol within 6 months of screening - Use of concomitant drugs unless authorized by the Sponsor Medical Monitor - Known contraindication and/or allergy to heparin - Smoking > 10 cigarettes a day - Considered unsuitable for inclusion by the Principal Investigator Exclusion Criteria for Cohorts EE and FF: - Myocardial infarction, percutaneous transluminal coronary intervention, or coronary artery bypass graft surgery within 12 weeks prior to screening, or cerebrovascular accident within 24 weeks prior to screening. Participants with adequately treated stable angina, per Investigator assessment, may be included - Congestive heart failure defined by NYHA Classes III or IV - Type 2 diabetes mellitus (T2DM) with HbA1c > 8.0% - Prior treatment with gene therapy - Currently receiving apheresis treatments or last apheresis treatment was within 8 weeks of screening

Study Design


Intervention

Drug:
IONIS ANGPTL3-LRx

Placebo
0.9%NaCl, water, riboflavin

Locations

Country Name City State
Canada Clinical Site Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Ionis Pharmaceuticals, Inc. Akcea Therapeutics

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability of single and multiple doses of IONIS ANGPTL3-LRx (incidence, severity, and dose-relationship of adverse effects and changes in the laboratory parameters) The safety and tolerability of IONIS ANGPTL3-LRx will be assessed by determining the incidence, severity, and dose-relationship of adverse effects and changes in the laboratory parameters by dose. Safety results in subjects dosed with IONIS ANGPTL3-LRx will be compared with those from subjects dosed with placebo. Up to Day 127
Primary Pharmacokinetics after single and multiple doses of IONIS ANGPTL3-LRx. The plasma pharmacokinetics (concentration-time results) of IONIS ANGPTL3-LRx (unconjugated and conjugated ASO) will be assessed following single and multiple-dose SC administration. The amount of IONIS ANGPTL3-LRx excreted in urine at selected 24-hour intervals will also be determined. Up to Day 127
Primary Pharmacodynamics of IONIS ANGPTL3-LRx (Changes in serum ANGPTL3 levels) Changes in serum angiopoietin-like 3 (ANGPTL3) levels compared to baseline. Up to Day 127
Secondary Pharmacodynamic effects of IONIS ANGPTL3-LRx Effects of IONIS ANGPTL3-LRx on changes in ANGPTL3 plasma protein compared to baseline. Up to Day 127
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