Evidence map›Paper›PMID 32589506›Full record

Trial reportNucleic acid therapeutics2020

Treatment with Volanesorsen, a 2'-O-Methoxyethyl-Modified Antisense Oligonucleotide Targeting

Lynnetta M Watts, Ewa Karwatowska-Prokopczuk, Eunju Hurh, Veronica J Alexander, Kristin Balogh, Louis O'Dea, Richard S Geary, Sotirios Tsimikas

Open access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Nucleic acid therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.1field-weighted citation impact, top 48% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. Target, silence, replace: a review on RNA-based drugs in modern medicine.Frontiers in cell and developmental biology · 2026
    Review
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Lynnetta M WattsClinical Development, Ionis Pharmaceutical, Inc, Carlsbad, California, USA.
Ewa Karwatowska-ProkopczukClinical Development, Akcea Therapeutic, Boston, Massachusetts, USA.
Eunju HurhClinical Development, Akcea Therapeutic, Boston, Massachusetts, USA.
Veronica J AlexanderClinical Development, Ionis Pharmaceutical, Inc, Carlsbad, California, USA.
Kristin BaloghClinical Development, Ionis Pharmaceutical, Inc, Carlsbad, California, USA.
Louis O'DeaClinical Development, Akcea Therapeutic, Boston, Massachusetts, USA.
Richard S GearyClinical Development, Ionis Pharmaceutical, Inc, Carlsbad, California, USA.
Sotirios TsimikasClinical Development, Ionis Pharmaceutical, Inc, Carlsbad, California, USA.
Ionis Pharmaceuticals (United States) · USAkebia Therapeutics (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of this study was to assess the effect of volanesorsen on the corrected QT (QTc) interval. This thorough QT study enrolled 52 healthy male and female subjects who were randomized at a single site in a four-way crossover study. Subjects were randomly assigned to 1 of 12 treatment sequences and crossed over into four treatment periods over the course of which each subject was to receive a single therapeutic dose of volanesorsen as a 300 mg subcutaneous (SC) injection, a single supratherapeutic dose of volanesorsen as 300 mg intravenous (IV) infusion, a single oral (PO) dose of moxifloxacin (positive control), and placebo dose. The study demonstrated that volanesorsen 300 mg SC and 300 mg IV did not have a clinically relevant effect on ΔΔQTcF exceeding 10 ms. The largest mean effect at any postdose time point was 3.0 ms (90% confidence interval [CI]: 0.8-5.2) after SC dosing and 1.8 ms (90% CI -0.4 to 4.0) after IV dosing. Volanesorsen, at the studied therapeutic and supratherapeutic doses, does not have a clinically meaningful effect on the QTc.

Indexed as

AdultApolipoprotein C-IIIDose-Response Relationship, DrugDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsElectrocardiographyFemaleHealthy VolunteersHumansHypertriglyceridemiaMaleMoxifloxacinOligonucleotidesOligonucleotides, AntisensePlacebo EffectRNA, MessengerAPOC3 protein, humanApolipoprotein C-IIIISIS 304801MoxifloxacinOligonucleotidesOligonucleotides, AntisenseRNA, MessengerTriglyceridesantisense oligonucleotideQTc intervalsubcutaneous (SC) therapeutic dosesupratherapeutic dosevolanesorsen

Identifiers

PMID32589506
PMCPMC7415887
OpenAlexW3037684925

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.