A Phase 3 Study to Evaluate the Effectiveness and Safety of Enlicitide with Rosuvastatin in Adults With High Cholesterol

What this Trial Is About

Researchers are studying a medicine called enlicitide to lower low-density lipoprotein cholesterol LDL-C in people with high cholesterol. This trial aims to learn if enlicitide given with rosuvastatin, a standard cholesterol-lowering treatment, works better than a placebo. The study is a phase 3, randomized, double-blind, placebo-controlled trial evaluating the combinations effect on LDL-C levels in adults with hyperlipidemia. Participants will be assigned to one of four groups enlicitide with a placebo matching rosuvastatin, enlicitide with rosuvastatin, rosuvastatin with a placebo matching enlicitide, or placebos for both drugs. All treatments are taken orally once daily for up to 12 weeks. This setup helps researchers compare the effects of enlicitide alone, rosuvastatin alone, their combination, and placebo. During the study, participants will have their LDL-C levels measured at baseline and at weeks 8 and 12. Researchers will also monitor apolipoprotein B, non-high-density lipoprotein cholesterol, lipoproteina, and adverse events. The main outcome is the percent change in LDL-C at week 8. Safety and tolerability are assessed throughout the treatment and up to about 20 weeks. The total participation duration is up to 12 weeks of treatment with follow-up monitoring.

A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)