Yardley

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 evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms: the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are studying the safety and effects of a drug called DII235 in adults who have high levels of lipoprotein(a), a factor linked to heart disease and diabetes. This study is a Phase 2, randomized, double-blind trial aiming to find the best dose and to understand how DII235 affects lipoprotein(a) levels over time compared to a placebo. Participants will be randomly assigned to one of five groups: four groups receiving different doses of DII235 and one group receiving a placebo (saline solution). The drug is given as an injection. The study will monitor participants from the start through Day 360, measuring changes in lipoprotein(a) levels at several points, especially between Day 60 and Day 360. During the study, participants will have regular assessments including blood tests to measure lipoprotein(a) levels, safety evaluations, and tolerability checks. Researchers will observe the percentage change in lipoprotein(a) from baseline and the proportion of participants reaching certain target levels. The study duration per participant will cover at least 180 to 360 days, with careful monitoring for any side effects or safety concerns throughout.

This research aims to evaluate whether the medicine vicadrostat, combined with empagliflozin, helps adults who have chronic heart failure with a weakened heart pumping function, defined by a left ventricular ejection fraction under 40%. Participants must have been diagnosed with chronic heart failure for at least three months and have symptoms classified as New York Heart Association class II to IV. The study is a Phase III trial conducted by Boehringer Ingelheim to assess the efficacy and safety of these medicines compared to placebo with empagliflozin. Participants are randomly assigned to one of two groups: one group receives vicadrostat plus empagliflozin tablets, and the other group receives placebo tablets plus empagliflozin. Tablets are taken once daily for a period ranging from about six months up to approximately three and a half years. Participants continue their usual heart failure treatments during the study. The trial includes regular study visits and phone contacts to monitor health and treatment effects. During the study, participants will have their health regularly checked, including monitoring for worsening heart failure symptoms, hospitalizations, or death related to heart failure. They will also complete questionnaires about their well-being. The main measure is the time until the first cardiovascular death, hospitalization for heart failure, or urgent heart failure visit. Researchers will compare these outcomes between treatment groups to see if the combined treatment affects these events. Safety and any unwanted effects will be closely tracked throughout the study period, which can last up to about 3.5 years.

Researchers are evaluating the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed a prior double-blind study. This open-label extension study follows participants from the parent trial (CTQJ230A12301) to continue monitoring the effects of pelacarsen over an extended period. Participants will receive pelacarsen 80 mg once a month by subcutaneous injection during the open-label extension. This single-arm, multicenter study lasts up to 36 months, providing continued access to the study drug for those who completed the parent trial while still on the investigational product. During the study, participants will be regularly assessed for adverse events and cardiovascular outcomes, including major cardiovascular events tracked from both the parent study baseline and the extension study baseline. Lipoprotein(a) levels will be measured at multiple time points to monitor changes over the course of the study. Safety and tolerability data will be collected up to 36 months, with ongoing monitoring by the research team throughout the study duration.

Researchers are conducting a study to better understand the functional losses or abilities experienced by individuals with Duchenne Muscular Dystrophy (DMD) and how these relate to their independence and quality of life. This study gathers insights from both individuals with DMD and their caregivers through detailed interviews to capture their perspectives. The study is observational and does not involve treatment, though some participants may currently be on a drug called givinostat. The study involves semi-structured interviews lasting about 60 minutes, focusing on functional abilities and independence. Participants include boys with DMD and caregivers, some of whom have been treated with givinostat for at least two years, and others who have not been treated with this drug. Interviews are conducted via video or audio recording, and participants must be willing and able to participate in this format. Participants will be asked to share their experiences during interviews conducted remotely. Researchers will evaluate the qualitative information gathered from these interviews to understand the impact of DMD on daily life and independence. The primary outcome is the content and insights from these 60-minute interviews. The study is expected to continue until December 2026, with participation involving a single interview session.

Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

This clinical trial is a rollover study designed for participants who have previously taken part in specific Incyte-sponsored clinical trials involving the drug povorcitinib. The study focuses on individuals with Hidradenitis Suppurativa (HS) who have already completed treatment in a parent trial and aims to continue evaluating their responses and safety over time. It is a Phase 3b, multicenter study sponsored by Incyte Corporation. Participants will continue receiving povorcitinib orally, following the same dosing schedule and options as in their original parent study. This rollover study allows participants to maintain their treatment regimen as determined initially, ensuring a consistent approach to medication administration and monitoring. During the study, participants will be closely monitored for treatment-emergent adverse events over approximately three years. Researchers will also assess clinical benefits such as the count of abscesses and nodules at each visit. The study includes regular evaluations to track safety, adherence to protocol, and overall health, with a focus on long-term outcomes for participants continuing povorcitinib treatment.