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NCT03360747

Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS)

Completed Phase 2 Results posted Last updated 7 January 2021
What this trial tests

Phase 2 trial testing AKCEA-ANGPTL3-LRx in Familial Chylomicronemia Syndrome in 3 participants. Completed in 4 September 2018.

Timeline
21 December 2017
Primary endpoint
12 June 2018
4 September 2018

Quick facts

Lead sponsorAkcea Therapeutics
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment3
Start date21 December 2017
Primary completion12 June 2018
Estimated completion4 September 2018
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Akcea Therapeutics — full company profile →

Who can join

18 and older, any sex, with Familial Chylomicronemia Syndrome or Lipoprotein Lipase Deficiency. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Absolute Change From Baseline to Month 3 in Fasting Triglycerides (TG) Primary · Baseline to Month 3

Baseline was defined as the average of Day 1 predose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. Month 3 was defined as the average of Week 13 and Week 14 fasting assessments.

GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-550.00± 431.471
Percent Change From Baseline to Month 3 in Fasting Triglycerides (TG) Primary · Baseline to Month 3

Baseline was defined as the average of Day 1 predose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. Month 3 was defined as the average of Week 13 and Week 14 fasting assessments.

GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-32.83± 31.994
Absolute Change From Baseline to Month 3 in Fasting Angiopoietin-Like 3 (ANGPTL3) Secondary · Baseline to Month 3

Baseline was defined as the average of Day 1 predose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. Month 3 was defined as the average of Week 13 and Week 14 fasting assessments.

GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-31.983± 5.4773
Percent Change From Baseline to Month 3 in Fasting Angiopoietin-like 3 (ANGPTL3) Secondary · Baseline to Month 3

Baseline was defined as the average of Day 1 predose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. Month 3 was defined as the average of Week 13 and Week 14 fasting assessments.

GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-51.249± 4.9093
Fasting Lipid and Lipoprotein Measurements at Month 3 Secondary · Month 3

Fasting lipid and lipoprotein measurements included non-HDL-C, ApoB, HDL-C, ApoA-1, VLDL-C and LDL-C. Month 3 was defined as the average of Week 13 and Week 14 fasting assessments.

Non-HDL-C
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg217.33± 119.618
ApoB
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg64.53± 4.899
HDL-C
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg13.0± 1.00
ApoA-1
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg77.3± 6.03
VLDL-C
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg190.17± 128.861
LDL-C
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg27.17± 10.324
Absolute Change From Baseline to Month 3 in Other Fasting Lipid Parameters Secondary · Baseline to Month 3

Other fasting lipid measurements included total cholesterol (TC), non-HDL-C, ApoB, HDL-C, ApoA-1, VLDL-C, and LDL-C. Baseline was defined as average of Day 1 predose fasting assessment and last fasting measurement prior to Day 1 pre-dose fasting assessment. Month 3 was defined as the average of Week 13 and Week 14 fasting assessments.

Absolute Change From Baseline to Month 3 in TC
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-86.17± 48.581
Absolute Change From Baseline to Month 3:Non-HDL-C
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-83.83± 48.235
Absolute Change From Baseline to Month 3 in ApoB
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-8.12± 5.352
Absolute Change From Baseline to Month 3 in HDL-C
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-2.3± 0.58
Absolute Change From Baseline to Month 3 in ApoA-1
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-17.3± 11.93
Absolute Change From Baseline to Month 3 in VLDL-C
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-82.50± 51.215
Absolute Change From Baseline to Month 3 in LDL-C
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-1.33± 3.753
Percent (%) Change From Baseline to Month 3 in Other Fasting Lipid Parameters Secondary · Baseline to Month 3

Other fasting lipid measurements included TC, non-HDL-C, ApoB, HDL-C, ApoA-1, VLDL-C, and LDL-C. Baseline was defined as average of Day 1 predose fasting assessment and last fasting measurement prior to Day 1 pre-dose fasting assessment. Month 3 was defined as the average of Week 13 and Week 14 fasting assessments.

% Change From Baseline to Month 3 in TC
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-30.39± 20.436
% Change From Baseline to Month 3 in Non-HDL-C
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-31.49± 21.832
% Change From Baseline to Month 3 in ApoB
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-10.73± 6.021
% Change From Baseline to Month 3 in HDL-C
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-15.2± 3.22
% Change From Baseline to Month 3 in ApoA-1
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-17.8± 10.97
% Change From Baseline to Month 3 in VLDL-C
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-36.03± 28.044
% Change From Baseline to Month 3 in LDL-C
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-6.47± 13.426
Change From Baseline to Day 92 in Maximum Postprandial Triglycerides (TG) Secondary · Baseline to Day 92

Participants consumed standardized pre-cooked meals (lunches and dinners and instructions for breakfasts and snacks) for 2 days prior to the postprandial assessments. Change from Baseline to Day 92 in maximum postprandial TG was assessed.

GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg-338.0± 38.22
Number of Participants Who Experienced Abdominal Pain During the Treatment Period Secondary · Days 1, 29, 57 and 92
GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg1
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Secondary · From time of informed consent to end of follow-up period (Up to Week 26)

An adverse event (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 is considered related to the investigational drug product. A TEAE was defined as any AE starting on or after the first dose of the study drug.

GroupValue95% CI
AKCEA-ANGPTL3-LRx 20 mg3

Adverse events — posted to ClinicalTrials.gov

Time frame: From time of informed consent to end of follow-up period (Up to Week 26).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AKCEA-ANGPTL3-LRx 20 mg
Serious: 0/3 (0%)
Deaths: 0/3
Other adverse events (10 terms — click to expand)

ReactionSystemAKCEA-ANGPTL3-LRx 20 mg
HeadacheNervous system disorders
AstheniaGeneral disorders
Influenza like illnessGeneral disorders
Back painMusculoskeletal and connective tissue disorders
Musculoskeletal chest painMusculoskeletal and connective tissue disorders
Vertigo positionalEar and labyrinth disorders
InfluenzaInfections and infestations
HyperlipidaemiaMetabolism and nutrition disorders
Loss of libidoPsychiatric disorders
Mood swingsPsychiatric disorders

Data from ClinicalTrials.gov NCT03360747 adverse events section.

Sponsor's own description

This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3-LRx for reduction of triglyceride (TG) levels in participants with FCS.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Angiopoietin-Like Proteins in Angiogenesis, Inflammation and Cancer.
    Carbone C, Piro G, Merz V, Simionato F, et al · · 2018 · cited 168× · PMID 29389861 · DOI 10.3390/ijms19020431
  2. Small non-coding RNA therapeutics for cardiovascular disease.
    Shah AM, Giacca M. · · 2022 · cited 60× · PMID 36106499 · DOI 10.1093/eurheartj/ehac463
  3. RNA Therapeutics in Cardiovascular Precision Medicine.
    Laina A, Gatsiou A, Georgiopoulos G, Stamatelopoulos K, et al · · 2018 · cited 59× · PMID 30090066 · DOI 10.3389/fphys.2018.00953
  4. RNA Therapeutics: the Next Generation of Drugs for Cardiovascular Diseases.
    Bejar N, Tat TT, Kiss DL. · · 2022 · cited 32× · PMID 35364795 · DOI 10.1007/s11883-022-01007-9
  5. Advances in Dyslipidaemia Treatments: Focusing on ApoC3 and ANGPTL3 Inhibitors.
    Tomlinson B, Wu QY, Zhong YM, Li YH. · · 2024 · cited 29× · PMID 38299167 · DOI 10.12997/jla.2024.13.1.2
  6. RNA-based therapy in the management of lipid disorders: a review.
    Blom DJ, Marais AD, Moodley R, van der Merwe N, et al · · 2022 · cited 16× · PMID 35459248 · DOI 10.1186/s12944-022-01649-3
  7. Rare Treatments for Rare Dyslipidemias: New Perspectives in the Treatment of Homozygous Familial Hypercholesterolemia (HoFH) and Familial Chylomicronemia Syndrome (FCS).
    D'Erasmo L, Bini S, Arca M. · · 2021 · cited 16× · PMID 34468855 · DOI 10.1007/s11883-021-00967-8
  8. Apolipoprotein CIII and Angiopoietin-like Protein 8 are Elevated in Lipodystrophy and Decrease after Metreleptin.
    Lightbourne M, Wolska A, Abel BS, Rother KI, et al · · 2021 · cited 7× · PMID 33442570 · DOI 10.1210/jendso/bvaa191

Verify or expand the search:

Other trials of AKCEA-ANGPTL3-LRx

Trials testing the same drug.

Other recruiting trials for Familial Chylomicronemia Syndrome

Currently open trials in the same condition.

Other Akcea Therapeutics trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03360747.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing