golocdacimab (MEDI6570) / AstraZeneca - LARVOL DELTA

GOLDILOX: Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction (clinicaltrials.gov) - P2 | N=423 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed | Phase classification: P2b ➔ P2

Phase classification • Trial completion • Cardiovascular • Coronary Artery Disease • Heart Failure • Inflammation • Myocardial Infarction

Identification of Response Biomarkers and Signaling Pathways Associated With the LOX-1 Blockade by MEDI6570 in Type 2 Diabetes (AHA 2022) - P1, P2b | "Findings indicate that IL-16 and IL-18 may be potential links between LOX-1 signaling and cardiovascular risk, being modified by treatment with MEDI6570. This study also identified neutrophil-related markers in response to MEDI6570 treatment, implicating a potential role for neutrophils in LOX-1-mediated effects. A phase 2 study in patients with recent ACS and treatment with MEDI6570 or placebo is ongoing (NCT04610892)."

Biomarker • Acute Coronary Syndrome • Congestive Heart Failure • Diabetes • Dyslipidemia • Inflammation • Metabolic Disorders • Type 2 Diabetes Mellitus • CEACAM8 • IL16 • IL18

Lectin-Like Oxidized Low-Density Lipoprotein Receptor 1 Inhibition in Type 2 Diabetes: Phase 1 Results. (PubMed, J Am Heart Assoc) - P1 | "Conclusions MEDI6570 was well tolerated and demonstrated dose-dependent soluble LOX-1 suppression and a pharmacokinetic profile consistent with once-monthly dosing. Registration URL: https://clinicaltrials.gov/; Unique identifier: NCT03654313."

Journal • P1 data • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus

GOLDILOX: Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction (clinicaltrials.gov) - P2b | N=392 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2023 ➔ Feb 2024 | Trial primary completion date: Nov 2023 ➔ Feb 2024

Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • Coronary Artery Disease • Heart Failure • Immunology • Inflammation • Myocardial Infarction

GOLDILOX: Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction (clinicaltrials.gov) - P2b | N=400 | Recruiting | Sponsor: AstraZeneca | Trial primary completion date: Apr 2023 ➔ Aug 2023

Trial primary completion date • Cardiovascular • Coronary Artery Disease • Heart Failure • Immunology • Inflammation • Myocardial Infarction

GOLDILOX: Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction (clinicaltrials.gov) - P2b | N=400 | Recruiting | Sponsor: AstraZeneca | N=792 ➔ 400

Enrollment change • Cardiovascular • Coronary Artery Disease • Heart Failure • Immunology • Inflammation • Myocardial Infarction

GOLDILOX: Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction (clinicaltrials.gov) - P2b; N=792; Recruiting; Sponsor: AstraZeneca; Trial primary completion date: Jul 2022 ➔ Apr 2023

Clinical • Trial primary completion date • Cardiovascular • Coronary Artery Disease • Heart Failure • Immunology • Inflammation • Myocardial Infarction

[VIRTUAL] THE SAFETY AND EFFICACY OF SINGLE AND MULTIPLE ASCENDING DOSES OF MEDI6570 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS (ACC 2021) - P2b | "MEDI6570 was well tolerated and demonstrated target engagement with dose-dependent decreases in free sLOX-1. The GOLDILOX-TIMI 69 trial (NCT04610892) will test the hypothesis that LOX-1 receptor blockade with MEDI6570 will regress coronary atherosclerosis."

Clinical • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Diabetes • Dyslipidemia • Immunology • Inflammation • Metabolic Disorders • Type 2 Diabetes Mellitus

GOLDILOX: Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction (clinicaltrials.gov) - P2b; N=792; Recruiting; Sponsor: AstraZeneca; Trial completion date: Apr 2023 ➔ Aug 2023

Clinical • Trial completion date • Cardiovascular • Coronary Artery Disease • Heart Failure • Immunology • Inflammation • Myocardial Infarction

GOLDILOX: Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction (clinicaltrials.gov) - P2b; N=792; Recruiting; Sponsor: AstraZeneca; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Cardiovascular • Coronary Artery Disease • Heart Failure • Immunology • Inflammation • Myocardial Infarction

GOLDILOX: Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction (clinicaltrials.gov) - P2b; N=792; Not yet recruiting; Sponsor: AstraZeneca

Clinical • New P2b trial • Cardiovascular • Coronary Artery Disease • Heart Failure • Immunology • Inflammation • Myocardial Infarction

A Study to Evaluate the Efficacy and Safety of MEDI6570 in Participantswith a Prior Heart Attack (clinicaltrialsregister.eu) - P2; N=792; Ongoing; Sponsor: AstraZeneca AB

Clinical • New P2 trial • Cardiovascular • Immunology • Inflammation • Myocardial Infarction

Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1; N=88; Completed; Sponsor: MedImmune LLC; Active, not recruiting ➔ Completed

Trial completion • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1; N=88; Active, not recruiting; Sponsor: MedImmune LLC; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: MedImmune LLC; Trial completion date: Jan 2020 ➔ Jun 2020; Trial primary completion date: Jan 2020 ➔ Jun 2020

Clinical • Trial completion date • Trial primary completion date