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

January 28, 2021 updated by: Akcea Therapeutics

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 5G8
        • Clinical Site
      • Toronto, Ontario, Canada, M3M 3E5
        • Clinical Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Clinical Site
      • Montréal, Quebec, Canada, H4A 2C6
        • Clinical Site
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Clinical Sites
      • Fountain Hills, Arizona, United States, 85268
        • Clinical Site
      • Glendale, Arizona, United States, 85306
        • Clinical Site
      • Mesa, Arizona, United States, 85206
        • Clinical Site
      • Mesa, Arizona, United States, 85213
        • Clinical Site
      • Phoenix, Arizona, United States, 85020
        • Clinical Site
      • Phoenix, Arizona, United States, 85023
        • Clinical Site
      • Phoenix, Arizona, United States, 85050
        • Clinical Site
    • California
      • Huntington Park, California, United States, 90255
        • Clinical Site
      • Los Angeles, California, United States, 90057
        • Clinical Site
      • Montclair, California, United States, 91710
        • Clinical Site
      • Panorama City, California, United States, 91402
        • Clinical Site
      • Poway, California, United States, 92064
        • Clinical Site
    • Florida
      • Boca Raton, Florida, United States, 33487
        • Clinical Site
      • Jensen Beach, Florida, United States, 34957
        • Clinical Site
      • Jupiter, Florida, United States, 33458
        • Clinical Site
      • Miami, Florida, United States, 33165
        • Clinical Site
      • Port Saint Lucie, Florida, United States, 34952
        • Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Clinical Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Clinical Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Clinical Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Clinical Site
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Clinical Site
    • New Jersey
      • Bridgeton, New Jersey, United States, 08302
        • Clinical Site
      • Princeton, New Jersey, United States, 08540
        • Clinical Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27410
        • Clinical Site
      • High Point, North Carolina, United States, 27265
        • Clinical Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Clinical Site
      • Cincinnati, Ohio, United States, 45227
        • Clinical Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Clinical Site
    • Texas
      • Austin, Texas, United States, 78735
        • Clinical Site
      • Carrollton, Texas, United States, 75010
        • Clinical Site
      • Dallas, Texas, United States, 75234
        • Clinical Site
      • Houston, Texas, United States, 77058
        • Clinical Site
      • Hurst, Texas, United States, 76054
        • Clinical Site
      • San Antonio, Texas, United States, 78215
        • Clinical Site
      • San Antonio, Texas, United States, 78229
        • Clinical Site
    • Utah
      • Layton, Utah, United States, 84041
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Pooled Placebo
Participants from each cohort received placebo at a dose-matched volume of study drug, subcutaneously (SC).
Drug: Placebo
Placebo (Matched with ISIS 703802)
Other Names:
  • Sterile Normal Saline (0.9% NaCl)
Experimental: Cohort B: ISIS 703802, 40 mg Q4W
Participants received ISIS 703802, 40 milligrams (mg) SC once every 4 weeks for 6 doses.
Drug: ISIS 703802 40 mg
ISIS 703802 40 mg, administered via SC injection, once every 4 weeks for 6 doses.
Other Names:
  • AKCEA-ANGPTL3-LRx
  • IONIS-ANGPTL3-LRx
  • Vupanorsen
Experimental: Cohort C: ISIS 703802, 80 mg Q4W
Participants received ISIS 703802, 80 mg SC once every 4 weeks for 6 doses.
Drug: ISIS 703802 80 mg
ISIS 703802 80 mg, administered via SC injection, once every 4 weeks for 6 doses.
Other Names:
  • AKCEA-ANGPTL3-LRx
  • IONIS-ANGPTL3-LRx
  • Vupanorsen
Experimental: Cohort A: ISIS 703802, 20 mg QW
Participants received ISIS 703802, 20 mg once every week for 26 doses.
Drug: ISIS 703802 20 mg
ISIS 703802 20 mg, administered via SC injection, once every week for 26 doses.
Other Names:
  • AKCEA-ANGPTL3-LRx
  • IONIS-ANGPTL3-LRx
  • Vupanorsen

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Fasting Triglycerides Level at the Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
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.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Angiopoietin-Like 3 Protein at the Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
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
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Free Fatty Acid (FFA) at Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Lipoprotein(a) (Lp[a]) at the Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
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
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
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.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Fasting Plasma Glucose at the Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Hemoglobin A1c (HbA1c) at the Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Fasting Insulin at the Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in and HOMA-IR at the Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
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.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Fructosamine at Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Glycated Albumin at the Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Weight at the Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Percent Change From Baseline in Weight, SBP and DBP at Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C6
An ANCOVA model was performed on the percent change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C6
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
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
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
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the percent change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Percentage of Participants With HFF ≤ 8% by MRI-PDFF at the Primary Analysis Time Point
Time Frame: Week 27 for Cohort A, and Week 25 for Cohorts B and C
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.
Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Fatty Liver Index (FLI) at the Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
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.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at the Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Leptin at the Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Adiponectin at the Primary Analysis Time Point
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Subcutaneous Adipose Tissue (SAT) and Visceral Adipose Tissue (VAT) by Single Slice MRI at the Primary Analysis Timepoint
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Waist Circumference by Single Slice MRI at the Primary Analysis Timepoint
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Waist to Hip Ratio (WHR) at the Primary Analysis Timepoint
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Change From Baseline in Body Mass Index (BMI) at the Primary Analysis Timepoint
Time Frame: Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point.
Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 13 weeks post treatment period (up to 39 weeks)
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.
Up to 13 weeks post treatment period (up to 39 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akcea Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ionis Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ISIS 703802-CS2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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