Elmer

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 combination's 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, lipoprotein(a), 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.

Researchers are studying the use of ziltivekimab to treat people who have heart failure along with inflammation. The study aims to compare ziltivekimab with a placebo to understand its effects on heart failure and inflammation. This is a Phase 3 study sponsored by Novo Nordisk A/S, focusing on patients with heart failure who have mildly reduced or preserved heart function and systemic inflammation. Participants will receive monthly injections of either ziltivekimab or a placebo, administered under the skin using either a pre-filled syringe or a pen-injector. The study medicine is given once a month for up to 4 years, alongside standard heart failure care. Two groups exist: one receiving the active drug and the other receiving placebo injections, both continuing standard treatments. During the study, participants will attend up to 20 clinic visits and use a study app on their phones to record each injection and complete questionnaires. Researchers will monitor heart failure events such as hospitalizations and urgent visits, cardiovascular deaths, kidney function, inflammation markers, and quality of life measures over up to 48 months. Safety and disease progression will be closely followed throughout the study period.

Researchers are evaluating the effectiveness of inclisiran, a twice-yearly subcutaneous injection, in preventing major cardiovascular and limb events in patients undergoing percutaneous coronary intervention (PCI) or peripheral endovascular intervention (PVI). This pragmatic, randomized, double-blind, placebo-controlled study will enroll about 6,000 patients with symptomatic atherosclerotic cardiovascular disease, either coronary artery disease or peripheral artery disease, to understand how inclisiran may be used in real-world clinical practice. Participants will be randomly assigned to receive either inclisiran sodium 300 mg injections or a matching placebo. The injections will be given on Day 1, Month 3 (Day 90), and every six months thereafter. The first dose will be administered at or within 14 days after a successful revascularization procedure. All participants will continue to receive usual medical care throughout the study. The treatment period for each participant is expected to last up to approximately 45 months, with an average of 36 months of follow-up. During the study, participants will be monitored for major adverse cardiovascular events (MACE) and major adverse limb events (MALE), starting from randomization up to about four years. Researchers will also track cardiovascular deaths, all-cause deaths, and venous thromboembolic events. The study is event-driven, continuing until enough events have occurred to meet study goals. Participants will attend regular visits for injections and assessments, ensuring ongoing safety monitoring and evaluation of treatment effects.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.