Sungai Buloh

Researchers are evaluating the safety and effects of different doses of a new medicine called NNC0519-0130 in people living with chronic kidney disease, some of whom have type 2 diabetes and are overweight or obese. This Phase 2 study also compares NNC0519-0130 to semaglutide, an already prescribed medicine, and a placebo to see how they may improve kidney function. Participants will be randomly assigned to receive once-weekly subcutaneous injections of NNC0519-0130 with a fixed dose escalation until reaching a maintenance dose, semaglutide with a similar dosing schedule, or a placebo matching NNC0519-0130. The treatment period lasts up to 43 weeks with several dosing schemes and groups. During the study, participants will have their kidney function monitored through urine albumin-to-creatinine ratio changes at weeks 12, 24, and 36. Other assessments include estimated glomerular filtration rate, body weight changes, waist circumference, blood pressure, and glycated hemoglobin levels. Safety will be evaluated by tracking adverse events throughout the trial duration. Participants will be regularly assessed to understand the medicines effects and safety.

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.

Researchers are evaluating the effectiveness of claseprubart DNTH103 compared to a placebo in adults with chronic inflammatory demyelinating polyneuropathy CIDP. This Phase 3 study aims to assess treatment outcomes in participants with typical CIDP or certain CIDP variants, focusing on improving disease activity and disability measures. The study consists of several periods Part A includes an open-label phase lasting up to 13 weeks where participants receive an intravenous loading dose of claseprubart followed by subcutaneous injections every two weeks. Part B is a randomized, placebo-controlled, double-blind treatment phase lasting up to 52 weeks for those who respond to treatment in Part A, with participants receiving either claseprubart or placebo subcutaneously every two weeks. Eligible participants may then join an optional open-label extension lasting up to 104 weeks, continuing claseprubart treatment subcutaneously every two weeks, followed by a safety follow-up period of 40 weeks. Participants will undergo regular assessments throughout the study, including evaluations of disease relapse using the Adjusted Inflammatory Neuropathy Cause and Treatment INCAT score, disability scales, grip strength measurements, quality of life, fatigue severity, and antibody levels. Safety monitoring involves tracking adverse events and drug serum concentrations. The total study duration can extend up to approximately 209 weeks, including all treatment and follow-up phases, with careful monitoring of participants neurological stability and treatment responses.

Researchers are studying the use of VX-01, an oral medication, to treat people with moderate to severe Non-Proliferative Diabetic Retinopathy NPDR, a condition related to diabetes affecting the eyes. This Phase 2 clinical trial aims to evaluate how effective and safe VX-01 is compared to a placebo over one year of treatment, including how the body processes the drug and its effects on the disease. Participants will be randomly assigned to one of two groups one group will receive VX-01 tablets at a dose of 150 mg twice daily, and the other group will receive placebo tablets twice daily. The treatment period lasts 52 weeks, followed by a 12-week follow-up after treatment ends. The study is double-masked, meaning neither participants nor study staff know which treatment is being taken during the trial. During the study, participants will have their vision and eye health regularly assessed using standardized tests such as the Early Treatment Diabetic Retinopathy Study ETDRS letter score and diabetic retinopathy severity scores. Safety will be monitored by tracking any adverse events. Participants must attend scheduled visits for evaluations and agree to avoid other investigational studies during the trial. The main goal is to see how VX-01 affects diabetic retinopathy after one year of daily treatment.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Dementia is an increasing health concern in Malaysia that places significant stress on family members who provide care. Many of these informal caregivers face challenges such as limited knowledge about dementia, negative attitudes, and difficulties in daily caregiving tasks. These factors can increase caregiver stress and negatively impact the quality of care for people living with dementia. This study evaluates whether using the DemensiaKITA mobile health application can improve caregivers knowledge, attitudes, and caregiving practices, while reducing caregiver burden. The study is a non-randomized controlled trial involving dementia caregivers in Kuala Lumpur and Selangor. Participants will be divided into two groups an intervention group that uses the DemensiaKITA app regularly during the study period, and a control group that continues usual caregiving practices without access to the app. The app offers educational modules, attitude-shaping messages, practical caregiving tips, and self-monitoring tools to support caregiver well-being. Participants will be assessed before the intervention and again at one month and three months after starting. Researchers will collect data using validated questionnaires to measure changes in caregiver knowledge, attitude, and practice KAP as well as caregiver burden. The study aims to provide evidence on the apps effectiveness in supporting dementia caregivers and inform future community-based dementia support programs in Malaysia and similar settings.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating how effective three different methods of oral health education are for secondary school students aged 15 to 16 in Malaysia. The study compares traditional teaching methods, mobile health education via WhatsApp, and an immersive Metaverse platform to see how each impacts oral health knowledge, practices, and attitudes. This research aims to explore new digital ways to improve oral health education for youth in a more engaging and accessible manner. The study divides participants into three groups, each receiving one of the three interventions. The conventional group receives interactive lectures from trained dentists using presentations and models. The mHealth group gets oral health materials through a WhatsApp group with instant messages in Malay and English. The Metaverse group uses computers in their school lab to access an immersive Meta-OHE platform where they explore educational content and complete tasks. Each session lasts about 60 to 90 minutes and includes assessments before and after the intervention. Participants will complete assessments of their oral health knowledge, practices, and attitudes before and immediately after their assigned education session. The study takes place over six months from May to December 2024. It involves monitoring participants through questionnaires and interactive activities to measure changes in oral health understanding and behaviors. The research is designed to have minimal risk and aims to provide insights into how immersive technology may enhance oral health education.

Researchers are evaluating the long-term safety and tolerability of inclisiran in participants with heterozygous or homozygous familial hypercholesterolemia HeFH or HoFH. This open-label, single-arm, multicenter extension study includes participants who have completed prior pediatric ORION studies ORION-16, ORION-13, ORION-20, or ORION-19. The trial aims to provide continued access to inclisiran treatment while monitoring safety outcomes over an extended period. Participants receive inclisiran injections, with dosing based on their previous study participation and weight. Those from ORION-16 or ORION-13 receive a 300 mg dose equivalent to 284 mg inclisiran in a 1.5 mL solution. Participants from ORION-19 and ORION-20 receive weight-based dosing. The study allows ongoing treatment with inclisiran to assess long-term effects and tolerability. During the study, participants are monitored for treatment-emergent adverse events and serious adverse events from day one through up to 1080 days. Researchers also measure changes in LDL cholesterol levels from the baseline of the prior studies to the end of this extension. The involvement includes regular safety assessments and evaluations to ensure participant well-being throughout the study duration, which may last nearly three years.

Researchers are evaluating various antibiotic treatments for severe multidrug-resistant Gram-negative bacterial infections, focusing on bloodstream infections, ventilator-associated pneumonia, and hospital-acquired pneumonia caused by carbapenem-resistant Gram-negative bacteria. This innovative platform trial uses adaptive clinical designs to speed up assessment and optimize resources, aiming to find interventions that improve survival in these serious infections. The study compares multiple antibiotic regimens, including combinations like ColistinPolymyxin B with Sulbactam or TigecyclineEravacycline, Ceftazidime-avibactam alone or combined with other drugs, high-dose meropenem, and others. These treatments are given intravenously to patients with confirmed infections caused by resistant bacteria, with random assignment to different treatment groups. The trial includes a primary phase evaluating outcomes at 28 days post-randomisation. Participants will be monitored closely with clinical assessments at multiple time points, including 14, 28, 60, and 90 days after randomisation. Researchers will track all-cause mortality and other clinical outcomes to evaluate the effectiveness of each treatment. Safety and health economics outcomes will also be recorded. The study is led by the National University of Singapore and plans to run until the end of 2028.