Basic Information

Gene symbol LPA Synonyms AK38, APOA, LP Type of gene protein-coding
Gene perturbation-related omics dataset PerturbAtlas
Description lipoprotein(a)

GTO ID GTC0591
Trial ID 2016-003373-18
Disease Hypolipoproteinemia | Cardiovascular System Disease
Altered gene APOA
Therapeutic/Target gene Target gene
TherapyASO
Treatment Pelacarsen|IONIS-681257|ISIS 681257|Pelacarsen sodium|TQJ 230
PhasePhase2
Recruitment statusCompleted
TitleA Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Phase 2 Study of ISIS 681257 Administered Subcutaneously to Patients with Hyperlipoproteinemia(a) and Established Cardiovascular Disease (CVD)
Year2017
CountryCanada|Denmark|Germany|Netherlands|United States
Company sponsorAkcea Therapeutics, Inc.
Other ID(s)NCT03070782|ISIS 681257-CS6
Vector information
VectorNo vector was used

Clinical Result

Cohort1: dose level 1
Administration route subcutaneous injection
Dosage 20 mg, once every 4 weeks (Q4W)
Pts 48
Age Adult, Older_Adult
Outcome Geometric Mean (95% Confidence Interval) of Percent Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-C) is -7(-16 to 3)%, in the Plasma Levels of Apolipoprotein B (apoB) is -3(-9 to 4).
Adverse reactions 7/48(Cardiac disorders; Gastrointestinal disorders; General disorders; Neoplasms benign, malignant and unspecified, incl cysts and polyps; Nervous system disorders)
Cohort2: dose level 2
Administration route subcutaneous injection
Dosage 40 mg, once every 4 weeks (Q4W)
Pts 48
Age Adult, Older_Adult
Outcome Geometric Mean (95% Confidence Interval) of Percent Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-C) is -26(-33 to -18)%, in the Plasma Levels of Apolipoprotein B (apoB) is -15(-20 to -10).
Adverse reactions 7/48(Cardiac disorders; General disorders; Infections and infestations; Injury, poisoning and procedural complications; Musculoskeletal and connective tissue disorders; Psychiatric disorders; Reproductive system and breast disorders)
Cohort3: dose level 3
Administration route subcutaneous injection
Dosage 60 mg, once every 4 weeks (Q4W)
Pts 47
Age Adult, Older_Adult
Outcome Geometric Mean (95% Confidence Interval) of Percent Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-C) is -16(-24 to -7)%, in the Plasma Levels of Apolipoprotein B (apoB) is -8(-14 to -2).
Adverse reactions 1/48(All-cause mortality); 7/47(Cardiac disorders; Injury, poisoning and procedural complications; Neoplasms benign, malignant and unspecified, incl cysts and polyps; Vascular disorders)
Cohort4: dose level 4
Administration route subcutaneous injection
Dosage 20 mg, once every 2 weeks (Q2W)
Pts 48
Age Adult, Older_Adult
Outcome Geometric Mean (95% Confidence Interval) of Percent Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-C) is -17(-25 to -8)%, in the Plasma Levels of Apolipoprotein B (apoB) is -9(-15 to -3).
Adverse reactions 3/48(Cardiac disorders; Gastrointestinal disorders; Metabolism and nutrition disorders)
Cohort5: dose level 5
Administration route subcutaneous injection
Dosage 20 mg, once every 1 weeks (Q1W)
Pts 48
Age Adult, Older_Adult
Outcome Geometric Mean (95% Confidence Interval) of Percent Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-C) is -23(-31 to -14)%, in the Plasma Levels of Apolipoprotein B (apoB) is -16(-21 to -10).
Adverse reactions 1/48(All-cause mortality); 4/48(Infections and infestations; Injury, poisoning and procedural complications; Nervous system disorders; Psychiatric disorders; Surgical and medical procedures)

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