Effect of Orforglipron on Major Adverse Cardiovascular Events in Patients With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

The primary objective of this study is to evaluate the efficacy of orforglipron in reducing the risk of major adverse cardiovascular events compared to a placebo in patients with established atherosclerotic cardiovascular disease and/or chronic kidney disease. The investigation aims to demonstrate the superiority of the investigational agent in mitigating cardiovascular risks within this specific patient population. The trial also includes the assessment of safety.

The clinical trial includes a total of 5347 patients. The study population comprises both male and female individuals. Participants are selected based on the presence of heart disease, kidney disease, or a combination of both conditions. Specific medical conditions identified within the cohort include chronic kidney disease and atherosclerosis cardiovascular disease. The age range for the subjects is categorized under codes 3 and 4.

This is a Phase 3, randomized, double-blind, placebo-controlled, event-driven study. The investigation aims to evaluate the effect of orforglipron compared to a placebo on the incidence of major adverse cardiovascular events. The study population includes individuals with established atherosclerotic cardiovascular disease and/or chronic kidney disease. The primary endpoint is the time to the first occurrence of a composite endpoint, which includes nonfatal myocardial infarction, nonfatal stroke, hospitalization or urgent visit due to heart failure, coronary revascularization, or all-cause death. The duration from baseline to the end of the study is approximately 5 years. Participant involvement is expected to extend through the study completion, which is estimated to occur by September 2030.

Orforglipron is an experimental medication administered as an oral tablet containing orforglipron hemicalcium. The specific dosage for this investigational product is not specified in the provided data.

A placebo designed to match the experimental treatment is utilized as a comparator in the study.

The efficacy of orforglipron will be evaluated based on the time to first occurrence of a composite endpoint of major cardiovascular events. This composite endpoint comprises nonfatal myocardial infarction, nonfatal stroke, hospitalization or urgent visit due to heart failure, coronary revascularization, and all-cause death. These parameters will be monitored from baseline until the end of study, which is estimated to be approximately 5 years.