Yate

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.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with elevated systolic blood pressure, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial designed to assess heart failure events and cardiovascular death risks. Participants will be randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Those in the baxdrostat group may have their dose increased if they meet specific criteria. Before randomization, participants not already on SGLT2 inhibitors or treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg daily for 4 to 6 weeks. Study visits are scheduled at 2, 4, 8, 16, and 34 weeks after randomization, then approximately every four months. If a participant stops the blinded study treatment early, they will continue with open-label dapagliflozin unless specific discontinuation criteria are met. During the study, participants will undergo screening assessments, follow-up visits for monitoring, and data collection up to the study closure point based on event rates, which may last up to 38 months. Researchers will measure the occurrence of heart failure events, cardiovascular death, hospitalizations, and other cardiovascular outcomes. Participants will continue with scheduled visits and assessments even if they discontinue the blinded treatment, ensuring ongoing data collection and safety monitoring throughout the study period.