Batu Caves

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults who have type 2 diabetes mellitus T2DM with impaired kidney function. Participants are also on dapagliflozin 10 mg as part of their guideline-directed medical therapy for chronic kidney disease CKD, along with other glucose-lowering medications. This Phase III study aims to understand how elecoglipron performs in this specific group of patients. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are given orally once daily alongside background dapagliflozin 10 mg. The study uses a parallel design and includes a 40-week treatment period during which participants take their assigned medication. During the study, participants will have their blood sugar control measured through Hemoglobin A1c HbA1c levels from baseline to Week 40, which is the primary outcome. Additional assessments include body weight changes, blood pressure, fasting plasma glucose, and time to needing additional diabetes medication. Safety and tolerability will be monitored throughout the study, which lasts up to 40 weeks for each participant.

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus T2DM who are already being treated with insulin and other glucose-lowering medications. This Phase III study focuses on adults with T2DM who have had the condition for at least 90 days and meet certain health criteria. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are taken orally once daily. The study treatment period lasts up to 40 weeks, during which participants continue their background insulin and glucose-lowering medications. During the study, participants will have regular assessments to monitor changes in blood sugar control, including Hemoglobin A1c HbA1c, body weight, blood pressure, and insulin dose. Researchers will also track safety, side effects, and tolerability. The main outcome is the change in HbA1c from baseline to Week 40. Overall, participation involves visits for monitoring and evaluations over approximately 40 weeks.

Researchers are evaluating the addition of Saruparib AZD5305 to standard radiation therapy RT and androgen deprivation therapy ADT for men with high-risk or very high-risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 mutation. The study aims to determine if Saruparib improves metastases-free survival compared to placebo when added to these treatments. This phase 3 trial involves approximately 700 adult male participants. Participants are randomly assigned to receive either Saruparib or a matching placebo alongside physicians choice of ADT, with or without abiraterone and prednisoneprednisolone, depending on their cohort. Cohort A includes those receiving RT and continuous ADT, while Cohort B includes participants receiving RT, ADT, and abiraterone. Saruparib and placebo are administered orally. Treatment continues with close monitoring throughout the study. Participants will undergo scans including CT or MRI, bone scans, and PSMA-PET after their planned RT to confirm eligibility and monitor disease status. They will be followed for survival and disease progression for up to approximately 11 years. Researchers will assess metastasis-free survival, overall survival, prostate cancer-specific survival, biochemical recurrence, physical function, and urinary symptoms. Safety and drug levels will also be monitored. An independent committee will review safety and efficacy regularly throughout the trial.

Researchers are evaluating the effectiveness of icotrokinra JNJ-77242113 compared to a placebo in adults with active psoriatic arthritis PsA, including those who have and have not previously used biologic treatments. The study aims to assess how well icotrokinra reduces the signs and symptoms of PsA, focusing on improvements measured by the American College of Rheumatology ACR 20 response at Week 16. Participants are randomly assigned to receive one of two doses of icotrokinra or a matching placebo. Those initially receiving placebo will switch to one of the icotrokinra doses at Week 16. Participants who continue without discontinuing the study drug are eligible to enter a long-term extension phase, where they keep receiving their assigned icotrokinra dose. The treatment period involves regular monitoring and assessment of psoriatic arthritis symptoms. Throughout the study, participants will undergo various assessments, including evaluations of joint swelling and tenderness, skin psoriasis severity, fatigue, physical function, and quality of life. Laboratory tests such as C-reactive protein levels will be measured to monitor inflammation. Researchers will track responses using validated scales like the Psoriatic Area and Severity Index PASI and Investigator Global Assessment IGA. The total duration includes treatment and follow-up visits up to Week 16, with options for extended treatment in the long-term extension phase.

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.

This observational study focuses on adults with Type 2 Diabetes Mellitus T2DM who are evaluated to identify and describe their condition and treatment patterns. The study aims to better understand patients with T2DM, particularly those whose diabetes management is not fully controlled by lifestyle changes or stable glucose-lowering medications. AstraZeneca sponsors this study to help link patients to ongoing or future T2DM clinical trials. Participants with T2DM will undergo assessments including blood sample collection about 2 mL and evaluation of medical history, medication use, and HbA1c blood sugar levels. The study involves a single visit where these data are collected to characterize patient demographics and treatment trends. Those interested and willing to participate may be referred to other relevant T2DM studies based on these findings. During the single study visit, participants provide informed consent and undergo blood sampling and questionnaires about their health and medication use. Researchers measure HbA1c levels and document medical and surgical histories. The main outcomes include demographic information, medication usage patterns, and the potential referral of participants to future T2DM trials. The entire participation lasts only one day, focusing on capturing detailed baseline information.

Researchers are evaluating a medicine called nerandomilast for adults with systemic sclerosis, a condition affecting the skin and internal organs. The study focuses on people with limited or diffuse cutaneous systemic sclerosis who have had symptoms for less than 7 years. The goal is to see if nerandomilast helps improve symptoms and slows disease progression while assessing how well the medicine is tolerated. Participants are randomly assigned to one of two groups one takes nerandomilast tablets, and the other takes placebo tablets that look identical but do not contain medicine. Tablets are taken twice daily. The study lasts from 1 to about 4 years, with regular visits to the study site and phone check-ins. During visits, participants have blood tests and assessments of skin thickening, lung function, and organ health to monitor changes and treatment effects. Throughout the study, doctors monitor participants overall health and any side effects. They regularly assess safety and tolerability of the treatment. The main outcome measured is the time to disease progression or death over up to 4 years. Other outcomes include changes in skin scores, lung capacity, physical function, and disease impact questionnaires. Participants health is closely followed during the study period.

Researchers are evaluating a new health education method aimed at helping indigenous Orang Asli households in Selangor, Malaysia, prepare for Disease X and other outbreaks. This cluster randomized trial seeks to find out if a package including workshops, simulation exercises, and card games can improve these households readiness, awareness, attitudes, and proactive preparedness actions compared to receiving educational brochures alone. The study compares two groups one receiving the intervention package plus educational brochures, and the other receiving only the brochures. The intervention package is delivered once during a workshop. The control group gets brochures sourced from the Ministry of Health Malaysias Info Sihat website. Both groups will participate in surveys before the intervention, immediately after, and at 1- and 2-month follow-ups to assess changes. Participants will engage in the intervention activities or receive brochures, then complete four surveys to measure preparedness using scores and matrices. Researchers will track household preparedness, cognitive preparedness, and behavior related to outbreak readiness over the two-month follow-up. The study is sponsored by Universiti Teknologi Mara and includes adults aged 18 to 99 years old from Orang Asli communities.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

Researchers are evaluating whether a medicine called BI 764198 helps adults and adolescents with certain kidney conditions, including secondary focal segmental glomerulosclerosis, treatment-resistant primary minimal change disease, Alport Syndrome, and treatment-resistant primary membranous nephropathy. The study is a Phase II, randomized, double-blind, placebo-controlled trial designed to assess the safety, tolerability, pharmacokinetics, and efficacy of BI 764198 in these proteinuric kidney diseases. Participants are randomly assigned to one of two groups, with twice the chance of receiving BI 764198 compared to placebo. They take one tablet daily for 20 weeks while continuing their standard kidney disease medications. The study lasts about seven months, during which participants attend six in-person visits and have three phone calls. The trial includes multiple cohorts based on specific kidney conditions. During the study, doctors regularly collect urine samples to measure protein levels and blood samples to monitor kidney function. Researchers compare these results between the treatment and placebo groups to evaluate changes in proteinuria and kidney filtration rate. Participants health and any side effects are closely monitored throughout the trial.