First-in-Human MEDI6570 Diabetes Trial

This was a phase 1, first‐in‐human, randomized, placebo‐controlled, dose‐escalation study of single (part A) and multiple (part B) ascending doses of MEDI6570 in patients with type 2 diabetes. The primary objective was to assess the safety and tolerability of MEDI6570. Secondary objectives were to evaluate the pharmacokinetics and immunogenicity of MEDI6570. Exploratory objectives included the characterization of target engagement in blood, the effect on inflammatory and disease pathogenesis biomarkers, and the effect on high‐risk coronary plaque volume and coronary artery inflammation.

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Vavere A.L., Sinsakul M., Ongstad E.L., Yang Y., Varma V., Jones C., Goodman J., Dubois V.F., Quartino A.L., Karathanasis S.K., Abuhatzira L., Collén A., Antoniades C., Koren M.J., Gupta R, & George R.T. (2023). Lectin‐Like Oxidized Low‐Density Lipoprotein Receptor 1 Inhibition in Type 2 Diabetes: Phase 1 Results. Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, 12(3), e027540.

Publication 2023

Artery inflammation Biomarkers Blood Coronary Coronary artery Coronary volume Human Immunogenicity Inflammation Pathogenesis Patients Pharmacokinetics Placebo Plaque Safety Type 2 diabetes

Corresponding Organization :

Other organizations : AstraZeneca (United States), AstraZeneca (Sweden), University of Oxford, Jacksonville Center for Clinical Research

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Variable analysis

independent variables

Dose of MEDI6570 (single and multiple ascending doses)

dependent variables

Safety and tolerability of MEDI6570
Pharmacokinetics of MEDI6570
Immunogenicity of MEDI6570
Target engagement in blood
Effect on inflammatory and disease pathogenesis biomarkers
Effect on high-risk coronary plaque volume and coronary artery inflammation

control variables

Placebo

Annotations

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