drugset / Trial / NCT01609140

A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease

NCT01609140 ↗

Phase 2 Completed 248 enrolled Genentech, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the safety and cholesterol lowering effects of MPSK3169A when given as subcutaneous (SC) injections over a 24-week period to patients with a high risk of cardiovascular events and LDL-c levels well above goal.

Timeline

Start
2012-05
Primary completion
2013-05
Completion
2013-07

Outcome

Met primary endpoint

paper effects persisted to day 169 with the highest doses (reduction vs placebo up to 62 mg/dl [51%]) PMID 28343601 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject RG7652 Monoclonal antibody — Subcutaneous