Hastings

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.

Researchers are studying the effects of a drug called KAI-9531, given as a subcutaneous injection once a week, in adults living with obesity or overweight who also have type 2 diabetes. The main goal is to see if KAI-9531 is better than a placebo at reducing body weight and lowering hemoglobin A1c (HbA1c), a measure of blood sugar control, over a 76-week period. This Phase 3, randomized, double-blind, placebo-controlled trial focuses on those who have tried and struggled to lose weight through diet and exercise. Participants receive either KAI-9531 or a placebo through weekly injections under the skin. The study compares doses 3 and 4 of KAI-9531 against placebo to evaluate changes in body weight and HbA1c from the start of the study to week 76. The treatment is monitored closely throughout the trial to assess effectiveness and safety. During the study, participants will have their body weight and HbA1c measured at baseline and again at week 76 to observe changes. Researchers will also monitor safety and any side effects. The overall participation includes regular follow-ups and assessments to track progress and health status over the study duration.

This research aims to evaluate whether lowering blood phosphate levels in people with end-stage kidney disease (ESKD) who are on dialysis can reduce the risk of death or major heart-related events compared to maintaining higher phosphate levels. The study also looks at whether lowering phosphate improves physical health, fatigue, quality of life, patient satisfaction, and itching, as well as whether it is cost-effective. Hyperphosphatemia, or high phosphate in the blood, is common in ESKD and linked to higher death risk, but there is no strong trial evidence that lowering phosphate improves important patient outcomes. Participants will be randomly assigned to one of two groups: an intensive phosphate target group aiming to keep serum phosphate at or below 1.50 mmol/L using phosphate-lowering medications, or a liberal phosphate target group aiming for a higher phosphate range of 2.0 to 2.5 mmol/L. In the liberal group, all phosphate-lowering drugs at baseline will be stopped and only restarted if phosphate rises above 2.5 mmol/L. Medication choice and doses will be based on physicians' and participants' decisions to meet target levels. The trial is multinational and will include 3600 adults on dialysis. During the study, researchers will track major outcomes including cardiovascular death or serious heart and artery events over 5 years. They will also assess physical health, quality of life using the EQ5D-5L questionnaire, fatigue, itching, and overall survival. The study involves monitoring serum phosphate levels and medication use, and measuring cost-effectiveness of the treatment strategies. Participants will be followed closely to understand the safety and impact of the phosphate targets on their health and well-being.

Chronic kidney disease (CKD) affects over 800 million people worldwide and is expected to become the 5th leading cause of death by 2040. CKD progresses to kidney failure, increases risks of early death and heart disease, and reduces quality of life. Current treatments do not fully prevent kidney failure, so this trial aims to find the best treatment or combination of treatments to slow CKD progression. CAPTIVATE is a Phase III, international, multi-center, adaptive platform trial designed to answer multiple treatment questions efficiently within a single research framework. Participants receive study treatments, such as Finerenone or placebo tablets taken orally once daily, for two years. They may be involved in more than one treatment at the same time or at different times. Follow-up visits occur around 1 month, 3 months, 6 months, 12 months, 18 months, and 2 years after starting treatment, with a final visit one month after treatment ends. The trial is ongoing and flexible, allowing new treatments to be added or removed based on results. During the study, participants have blood and urine tests, safety assessments, and treatment adherence monitoring. Health information is collected at study visits and every five years to evaluate long-term outcomes. The main measurement is the change in kidney function (eGFR slope) from the start of treatment to week 108. The study continues recruiting participants for many years to improve CKD treatment options.

Researchers are evaluating whether an early three-day course of oral dexamethasone can improve recovery and wellbeing in children aged 4 to 17 years with Sydenham's chorea, a movement disorder caused by inflammation in the brain after a Group A streptococcus infection. This condition affects children's movements, mood, and concentration, and can take months to fully recover from. The study is a randomized, double-blinded, placebo-controlled phase 3 trial conducted in New Zealand and Australia, focusing on reducing symptoms and improving mental health outcomes. Participants will be randomly assigned to receive either oral dexamethasone suspension at a dose of 20mg/m2/day (up to 24mg/day) divided into three doses daily for three days, or matching placebo capsules taken three times daily for the same duration. The study compares the effects of this short steroid course against placebo to determine safety and effectiveness in treating Sydenham's chorea. The trial plans to enroll 80 children from multiple hospital sites. During the study, children's chorea severity and psychiatric symptoms will be assessed at one, three, and twelve months using standardized rating scales and questionnaires. Safety checks for adverse events related to dexamethasone will occur on days three, seven, and at one month. Additional outcomes include relapse rates, hospital length of stay, and treatment failures. The total follow-up period spans a year to monitor both physical and mental recovery.