Whangarei

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.

Researchers are evaluating several treatments for adults with kidney failure who have recently been diagnosed with calciphylaxis, a rare disease affecting about 1 to 2 people in 10,000. This phase 3 global platform trial aims to provide high-quality evidence on the effects of different therapies across various care areas. The study uses an adaptive design to add or remove treatment options based on ongoing results, improving how patients with this condition are treated. The trial begins with two main treatment areas the Dialysis Membrane Domain and the Pharmacotherapy Domain. In the Pharmacotherapy Domain, participants receive either Vitamin K1 capsules, Magnesium Citrate tablets, Sodium Thiosulfate injections, or placebos, with dosing schedules matched to their dialysis sessions. The Dialysis Membrane Domain compares two types of dialysis filters, high flux and medium cut-off dialysers, in an open-label design. Treatments are given according to these schedules, and new interventions may be added as the trial progresses. Participants will be monitored and assessed using the BEAT-Calci Wound Assessment Scale over 12 weeks as the primary outcome, with additional evaluations up to 26 weeks and beyond. Assessments include wound measurements, pain levels, analgesic use, quality of life, infection rates, hospital days, mortality, kidney transplantation status, and calciphylaxis recurrence. The study uses a Bayesian adaptive approach to adjust sample size and study arms based on collected data, continuing until clear results on treatment effects are reached.

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.

This research aims to evaluate the effects of lowering blood phosphate levels in adults with end-stage kidney disease ESKD who are receiving dialysis. Elevated phosphate levels are common in ESKD and linked to higher risk of death and heart problems, but it is unclear if reducing phosphate improves important patient outcomes. The study will compare intensive lowering of phosphate to a more liberal phosphate target to see if this reduces heart-related deaths and events, improves physical health, and is cost-effective. Participants will be randomly assigned to one of two groups one aiming for a liberal serum phosphate target of 2.0 to 2.5 mmolL, and the other aiming for an intensive target of 1.50 mmolL or lower. Doctors will decide the type and dose of phosphate-lowering medications to help participants reach their assigned phosphate levels, following usual local practices. The study will last up to five years and is conducted internationally with 3600 adults on dialysis. During the study, researchers will monitor participants for major heart-related events and deaths, physical health, fatigue, quality of life, patient satisfaction, and itching. Regular assessments will include measuring time to cardiovascular death or major cardiovascular events and evaluating overall survival and quality of life using the EQ5D-5L tool. The study will also assess cost-effectiveness and continue to observe participants for five years to collect comprehensive data on these outcomes.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

The trial investigates treatments for bloodstream infection caused by Staphylococcus aureus SAB, which can be life-threatening with a 15-30% death rate within three months. This international, multi-center randomized adaptive platform trial aims to find the best treatment options to reduce mortality within 90 days of infection. The trial adapts over time by assigning more patients to treatments that show better outcomes and removing less effective options. Participants receive various antibiotic treatments depending on their group. These include intravenous vancomycin or daptomycin, flucloxacillin or cloxacillin, cefazolin, or benzylpenicillin, with dosages adjusted for kidney function or illness severity. Some receive adjunctive drugs like clindamycin, and others may switch from intravenous to oral antibiotics if eligible after 7 or 14 days. Additionally, some participants undergo PETCT scans as part of the study. During the study, participants are monitored closely with blood cultures, temperature checks, and clinical assessments to track infection clearance and complications. Researchers measure all-cause mortality at 90 days as the primary outcome, along with other outcomes such as survival at earlier time points, hospital stay length, microbiological treatment failure, serious reactions, and antibiotic use. Safety and health economic data are also collected to evaluate treatments comprehensively throughout the trial.

Chronic kidney disease CKD affects over 800 million people worldwide and is expected to become the fifth leading cause of death by 2040. This trial investigates various treatments to find the best options or combinations that slow CKD progression and reduce the risk of kidney failure and related complications. The study is a Phase III, international, multi-center, adaptive, platform trial designed to answer multiple treatment questions efficiently within a common setup. Participants receive study treatments, such as finerenone tablets 10mg or 20mg or matched placebo tablets, taken orally once daily. Each treatment period lasts 2 years, with follow-up visits scheduled at about 1 month, 3 months, 6 months, 12 months, 18 months, and 2 years after starting treatment. A final visit occurs one month after completing the 2-year treatment phase. The trial is ongoing and allows participants to join multiple treatment arms either simultaneously or at different times. During the study visits, researchers collect blood and urine tests, evaluate safety, and monitor treatment adherence. Overall health status is assessed every 5 years. The main outcome measured is the change in kidney function eGFR slope from the start of treatment to week 108. Secondary outcomes include changes in albuminuria, kidney failure events, mortality, cardiovascular events, safety, and quality of life. The trial plans long-term follow-up and safety monitoring over several years.

This research aims to find out whether an early three-day oral steroid treatment called dexamethasone can improve both physical and mental recovery in children with Sydenhams chorea. Sydenhams chorea is a movement disorder caused by brain inflammation after an abnormal immune response to certain bacterial infections, affecting childrens movements, mood, and concentration. The condition commonly affects children with acute rheumatic fever, and recovery can take months. The study is a phase 3, randomized, double-blinded, placebo-controlled trial involving children in New Zealand and Australia. Participants will be randomly assigned to receive either oral dexamethasone or a placebo for three days. The dexamethasone dose is 20 mg per square meter of body surface per day, divided into three doses, with a maximum of 24 mg per day. The placebo group will take matching capsules on the same schedule. This short course treatment is being tested to see if it reduces the severity of Sydenhams chorea and its psychiatric symptoms. Children in the study will be monitored through scheduled visits on days three, seven, one month, three months, and twelve months. Researchers will assess chorea severity, relapse rates, psychiatric symptoms, hospital stay length, and treatment failure. Safety will be checked for any side effects possibly related to dexamethasone. The trial plans to recruit 80 participants, and overall involvement may last up to 12 months to track recovery and treatment effects comprehensively.