Study of ARO-ANG3 in Adults With Mixed Dyslipidemia

Patrocinador principal: Arrowhead Pharmaceuticals

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.

• Mixed Dyslipidemia

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

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

Apellido: Medical Monitor

Teléfono: 626-304-3400

Email: [email protected]

2021-04-01

Tipo: Sponsor

• Dyslipidemias

Etiqueta: ARO-ANG3

Tipo: Experimental

Descripción: ARO-ANG3 Injection

Etiqueta: Placebo

Tipo: Placebo Comparator

Descripción: Sterile Normal Saline (0.9% NaCl)

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

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