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Found 21 Actively Recruiting clinical trials
Actively Recruiting
Researchers are studying a trial medicine called MK-7262 to lower the level of Lipoproteina or Lpa in the blood. This trial also looks at another medicine named enlicitide, which lowers low-density lipoprotein cholesterol LDL-C. The study aims to find out if taking MK-7262 alone or together with enlicitide works better than a placebo in lowering Lpa and LDL-C levels. The safety and tolerability of these medicines are also being evaluated. Participants will be randomly assigned to one of four groups. One group will take both MK-7262 and enlicitide placebos, the second will take enlicitide with an MK-7262 placebo, the third will take MK-7262 with an enlicitide placebo, and the fourth will take both MK-7262 and enlicitide. All treatments are oral tablets taken once daily for about 12 weeks. During the study, participants will have their Lpa and LDL-C levels measured at baseline and at weeks 8 and 12 to assess changes. Researchers will monitor any adverse events and whether participants stop treatment due to side effects, with safety observed for up to approximately 20 weeks. The study also tracks other related outcomes like percentages of participants reaching specific Lpa levels. Overall participation lasts up to about 12 weeks of treatment plus follow-up.
Actively Recruiting
Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.
Actively Recruiting
Researchers are evaluating the effectiveness, safety, and tolerability of elecoglipron alone or combined with dapagliflozin compared with a placebo in adults with type 2 diabetes mellitus T2DM who are not adequately controlled by lifestyle management alone or who are on other background glucose-lowering medications. This Phase III study aims to understand how these treatments impact blood sugar control and related health factors. Participants will be randomly assigned to one of four groups elecoglipron at dose level 1 with dapagliflozin-matched placebo, elecoglipron at dose level 2 with dapagliflozin-matched placebo, a combination of elecoglipron at one of the studied doses with dapagliflozin, or matching placebos for both drugs. All treatments are taken orally once daily. The study uses a quadruple-blind design to compare these options over a treatment period lasting up to 40 weeks. During the study, participants will have their blood sugar levels measured by changes in Hemoglobin A1c HbA1c from baseline to week 40. Other assessments include body weight, blood pressure, and the time to start any additional rescue medication. Participants will attend regular visits for monitoring and safety evaluations throughout the study duration, which extends until the primary completion date in July 2028.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating a new care strategy for people at increased risk of atherosclerotic cardiovascular disease ASCVD but without symptoms. The study compares a Cleerly Coronary Artery Disease CAD Staging System-based care approach against the usual risk factor-based care to see if it better reduces cardiovascular events. This pragmatic, randomized trial addresses the need for improved methods to identify and personalize treatment for asymptomatic individuals at risk due to age, diabetes, prediabetes, or metabolic syndrome. Participants are randomly assigned to one of two groups. The risk factor-based care group receives usual care managed by their providers, while a cardiology team monitors and supports guideline-based treatment without revealing certain imaging results during the study. The Cleerly stage-based care group gets personalized management from a remote cardiologist-led team using the Cleerly CAD Staging System, which includes imaging to assess coronary atherosclerosis and guides pharmacotherapy and education. Treatment intensity may increase if plaque worsens after 24 months. During the study, participants will have assessments to monitor heart health and treatment adherence over an average of 3.5 years. Researchers will measure cardiovascular events and other related health outcomes to compare the two care strategies. The study involves ongoing medication monitoring, lab tests, and feedback to optimize prevention, with the goal of improving personalized care for cardiovascular risk management.
Actively Recruiting
Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.
Actively Recruiting
Researchers are evaluating the efficacy and safety of eloralintide in adults with moderate-to-severe obstructive sleep apnea who are also overweight or obese. This trial is structured as a master protocol called YDAO, which supports two studies YSA1 for participants who do not use or refuse Positive Airway Pressure PAP therapy, and YSA2 for those who have been on PAP therapy for at least three months and plan to continue it. The study aims to understand how eloralintide affects body weight and sleep apnea severity over time. Participants will be randomly assigned to receive either eloralintide or a placebo through subcutaneous injections once weekly. The study includes two parallel groups reflecting current PAP therapy use. Treatment lasts about 64 weeks, followed by assessments. The design includes double-blinding to compare the effects between intervention and placebo groups. During the study, participants will be closely monitored for changes in body weight and apnea-hypopnea index AHI at baseline and week 64. Additional measurements include blood pressure, triglycerides, inflammation markers, sleep-related impairment scores, and glucose metabolism. Researchers will also track patient-reported outcomes, medication use, and pharmacokinetics. Participation lasts approximately 76 weeks, covering screening, treatment, and follow-up evaluations to ensure safety and collect comprehensive data.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of solbinsiran compared to a placebo in adults with severe hypertriglyceridemia, a condition involving very high triglyceride levels. This Phase 2, randomized, double-blind, placebo-controlled study aims to understand how solbinsiran affects triglycerides and other lipid measures. The study focuses on participants with fasting triglyceride levels of 500 mgdL or higher. Participants will be randomly assigned to receive either solbinsiran or a placebo through two subcutaneous injections. The study uses a parallel design, meaning participants receive only one of the two treatments. The trial will last at least 24 weeks, with assessments occurring from baseline through weeks 16 to 24 to measure changes in triglycerides and other lipids. During the study, participants will undergo evaluations of lipid levels including triglycerides, Angiopoietin-like-3, very-low-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol. Pharmacokinetic assessments will be done to measure the drug concentration over time. Safety and efficacy will be monitored throughout the trial, which is expected to complete in August 2027.
Actively Recruiting
Study of TAK-360 Tablets for Adults With Narcolepsy Type 2 to Find Safe Dose and Improve Wakefulness
Narcolepsy Type 2 NT2 is a lifelong condition causing excessive daytime sleepiness, difficulty staying awake, and problems with concentration and memory, impacting daily life activities. Researchers are evaluating TAK-360, a drug that acts like orexin, a brain chemical that promotes wakefulness, to understand its safety, tolerability, and ability to help adults with NT2 stay awake. This is a Phase 2, randomized, double-blind, placebo-controlled study to find the right dosage of TAK-360. Participants will be randomly assigned to receive either TAK-360 tablets or matching placebo tablets orally for 4 weeks. TAK-360 is being studied to assess its effects compared to placebo. The study uses a parallel design and includes a 4-week treatment period where participants take the assigned tablets daily. During the study, participants will be monitored for treatment-emergent adverse events for up to 15 weeks. Researchers will assess wakefulness using tools like the Epworth Sleepiness Scale and the Maintenance of Wakefulness Test at baseline and after 4 weeks of treatment. Safety, tolerability, and efficacy data will be collected throughout the study, which runs until November 2026.
Actively Recruiting
Researchers are studying finerenone to evaluate its safety and effectiveness in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international trial is randomized, double-blind, and placebo-controlled, focusing on how finerenone compares to placebo in reducing heart failure events and cardiovascular death. Participants receive either oral finerenone or a matching placebo while hospitalized or recently discharged for heart failure. The study monitors patients over approximately 30 months to assess the total heart failure events, cardiovascular death, and adverse events related to the treatment. Throughout the study, participants undergo regular assessments including symptom scoring using the Kansas City Cardiomyopathy Questionnaire, monitoring for serious adverse events, and evaluation of heart failure outcomes. The study tracks safety and efficacy data over the long term, with follow-up visits scheduled to measure the impact of treatment on morbidity and mortality in heart failure patients.
Actively Recruiting
This research aims to learn about the safety and effects of the study medicine PF-07328948 for adults with heart failure. The study evaluates whether PF-07328948 is safe and effective compared to a placebo in people who already take standard heart failure medicines including SGLT2 inhibitors. It is a phase 2 randomized, double-blind, placebo-controlled trial sponsored by Pfizer. Participants will take either placebo tablets or one of three doses of PF-07328948 tablets once daily by mouth for 36 weeks. The study includes four groups placebo, low dose, medium dose, and high dose of PF-07328948. Treatment lasts 36 weeks, followed by monitoring and assessments. Participants will be involved for about 48 weeks with 15 visits to the study clinic, of which 5 may be performed at home by phone and 10 in person. Researchers will assess clinical events, 6-minute walk test distance, and heart failure symptom scores at baseline and week 36. Safety will be monitored through adverse event reporting up to week 40. Various questionnaires and physical tests will track health status and treatment effects throughout the study.
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