Study of ARO-ANG3 in Adults With Mixed Dyslipidemia

A Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-ANG3 in Adults With Mixed Dyslipidemia

Patrocinadores

Patrocinador principal: Arrowhead Pharmaceuticals

Fuente Arrowhead Pharmaceuticals
Resumen breve

The purpose of AROANG3-2001 is to evaluate the efficacy and safety of ARO-ANG3 in participants with mixed dyslipidemia. Participants will receive 2 subcutaneous injections of ARO-ANG3 or placebo.

Estado general Not yet recruiting
Fecha de inicio 2021-04-30
Fecha de Terminación 2023-04-30
Fecha de finalización primaria 2022-10-31
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Percent Change from Baseline in Fasting Triglycerides (TG) at Week 24 Baseline, Week 24
Resultado secundario
Medida Periodo de tiempo
Percent Change from Baseline in Fasting TG Over Time Baseline, up to Week 36
Percent Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 Baseline, Week 24
Percent Change from Baseline in Fasting Non-HDL-C Over Time Baseline, up to Week 36
Percent Change from Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24 Baseline, Week 24
Percent Change from Baseline in Fasting Total ApoB Over Time Baseline, up to Week 36
Percent Change from Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation at Week 24 Baseline, Week 24
Percent Change from Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Baseline, up to Week 36
Percent Change from Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 24 Baseline, Week 24
Percent Change from Baseline in ANGPTL3 Over Time Baseline, up to Week 36
Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24 Baseline, Week 24
Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time Baseline, up to Week 36
Change from Baseline in Plasma Concentrations of ARO-ANG3 Over Time Baseline, up to Week 12
Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) at Week 24 Week 24
Number of Participants with AEs and/or SAEs Through Week 36 up to Week 36
Inscripción 180
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: ARO-ANG3

Descripción: 2 doses of ARO-ANG3 by subcutaneous (sc) injection

Etiqueta de grupo de brazo: ARO-ANG3

Tipo de intervención: Drug

Nombre de intervención: Placebo

Descripción: calculated volume to match active treatment by sc injection

Etiqueta de grupo de brazo: Placebo

Elegibilidad

Criterios:

Inclusion Criteria: - Based on medical history, evidence of TG ≥ 150 mg/dL but ≤ 499 mg/dL on more than one occasion - Fasting levels at Screening of LDL-C ≥ 70 mg/dL OR non-HDL-C ≥ 100 mg/dL after at least 4 weeks of stable optimal statin therapy - Mean fasting TG ≥ 150 mg/dL and ≤ 499 mg/dL during Screening collected at two separate and consecutive visits and at least 7 days apart and not more than 14 days apart - Willing to follow diet counseling and maintain a stable diet per Investigator judgment based on local standard of care - Women of childbearing potential on must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception - Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1 - Willing to provide written informed consent and to comply with study requirements Exclusion Criteria: - Current use or use within 365 days from Day 1 of any hepatocyte targeted siRNA or antisense oligonucleotide molecule - Active pancreatitis within 12 weeks prior to Day 1 - Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study - Acute coronary syndrome event within 24 weeks of Day 1 - Major surgery within 12 weeks of Day 1 - Planned coronary intervention (e.g., stent placement or heart bypass) during the study - Uncontrolled hypertension - Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV) - Uncontrolled hypothyroidism or hyperthyroidism - Hemorrhagic stroke within 24 weeks of Day 1 - History of bleeding diathesis or coagulopathy - Current diagnosis of nephrotic syndrome - Systemic use of corticosteroids or anabolic steroids within 4 weeks prior to Day 1 or planned use during the study - Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply) Note: additional inclusion/exclusion criteria may apply per protocol

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Contacto general

Apellido: Medical Monitor

Teléfono: 626-304-3400

Email: [email protected]

Fecha de verificación

2021-04-01

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: ARO-ANG3

Tipo: Experimental

Descripción: ARO-ANG3 Injection

Etiqueta: Placebo

Tipo: Placebo Comparator

Descripción: Sterile Normal Saline (0.9% NaCl)

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov

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