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Активно (без набиране) Фаза 3 NCT06347133

Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

Фаза 3 – широко изпитване преди одобрение
Заболявания: Hypertriglyceridemia

Спонсор: Arrowhead Pharmaceuticals

Налично на: БГ
Обобщение
This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with hypertriglyceridemia (HTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo and be evaluated for efficacy and safety.
Кой може да участва
Inclusion Criteria: * Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening * Established diagnosis of hypertriglyceridemia (HTG) and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mm/L) and ≤499 mg/dL (≤5.64 mmol/L) * Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period * Fasting low density lipoprotein-cholesterol (LDL-C) ≤ 130 mg/dL (≤3.37 mmol/L) at screening * Screening HbA1c ≤9.0% * Willing to follow diet counseling and maintain a stable low-fat diet * Must be on standard of care lipid and TG-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator, including an inability to safely administer or re-administer a specific drug because of fear, preference, genetic, clinical, or metabolic considerations, or due a previous adverse reaction associated with, attributed to, or caused by specific drug) prior to collection of qualifying TG levels. Exclusion Criteria: * Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks. * Use of any other hepatocyte targeted siRNA or antisense Oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer * Acute pancreatitis within 4 weeks prior to screening * Body mass index \>45 kg/m\^2 Note: Additional Inclusion/Exclusion criteria may apply per protocol
Места на провеждане 15
Argentina (1)
Research Site 102
CABA , Buenos Aires
Австралия (1)
Research Site 107
Blacktown , New South Wales
България (1)
Research Site 111
Blagoevgrad
Канада (1)
Research Site 140
North Vancouver , British Columbia
Чехия (1)
Research Site 151
Prague , Prague
Франция (1)
Research Site 164
Marseille , Bouches du Rhone
Германия (1)
Research Site 170
Deggingen , Baden-Wurttemberg
Унгария (1)
Research Site 171
Békéscsaba
Италия (1)
Research Site 186
Rozzano , Milano
Полша (1)
Research Site 200
Bydgoszcz
Словакия (1)
Research Site 214
Banská Bystrica
South Africa (1)
Research Site 221
Centurion , Gauteng
Испания (1)
Research Site 234
Barcelona , Barcelona
Великобритания (1)
Research Site 236
Plymouth , Devon
САЩ (1)
Research Site 1
Birmingham , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
21.05.2024
Крайна дата
01.09.2026
Регистрационен номер
NCT06347133
Източник
anzctr
Запитване за медицински туризъм

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