Joondalup

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 combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are evaluating zipalertinib, an oral drug, for safety, effectiveness, and how it behaves in the body pharmacokinetics in adults with locally advanced or metastatic non-small cell lung cancer NSCLC that has specific mutations in the epidermal growth factor receptor EGFR, including exon 20 insertions and other uncommon mutations. This Phase 2b trial also studies how zipalertinib interacts with other drugs affecting liver enzymes and transporters and aims to find the best dose for treatment. Participants join one of four main groups based on their treatment history and mutation type those previously treated for exon 20 insertion mutations, those who are untreated but not candidates for standard chemotherapy, those with active brain metastases or leptomeningeal disease, and those with other uncommon EGFR mutations without prior systemic therapy. Two additional substudies focus on drug interactions using enzyme and transporter probe cocktails, and dose optimization with participants randomly assigned to two dosing arms. Zipalertinib is taken orally twice daily continuously until disease progression or other reasons to stop. During the study, participants undergo regular evaluations including scans to measure tumor response, brain imaging if applicable, laboratory tests, heart function monitoring, and assessments of side effects. Researchers track how long participants respond to treatment, disease control, survival, and changes in heart electrical activity. Safety and drug concentration in blood are closely monitored. Participants may remain in the study for up to approximately two years to assess these outcomes.

The trial investigates the effects of a combination treatment using Fluticasone Furoate FF, Umeclidinium UMEC, and Vilanterol VI on lung function compared to a combination of FF and VI alone. The study focuses on adolescents aged 12 to 17 years with asthma that is not adequately controlled despite stable maintenance therapy with inhaled corticosteroids and long-acting beta2-agonists. The research aims to assess efficacy, safety, tolerability, and pharmacokinetics over a 24-week period in this age group. Participants receive either the FFUMECVI combination or the FFVI combination, both administered via the ELLIPTA inhaler. The study is randomized, double-blind, and conducted in parallel groups. Treatments are given daily, and the trial lasts for 24 weeks to monitor the effects on lung function and asthma control. During the study, participants undergo lung function tests measuring forced expiratory volume in 1 second FEV1 at the start and after 24 weeks. Additional assessments include asthma control questionnaires at baseline and week 24 to evaluate changes in symptoms. Safety and tolerability are monitored throughout, with the total participation lasting 24 weeks.

Researchers are evaluating Pumitamig compared to Durvalumab in adults with unresectable stage III Non-small Cell Lung Cancer NSCLC who have completed concurrent chemoradiation therapy. This phase 3 study aims to assess which treatment better controls cancer progression and improves survival outcomes in this patient population. Participants are randomly assigned to receive either Pumitamig or Durvalumab at specified doses on designated days. Both treatments are administered following at least two cycles of platinum-based concurrent chemoradiotherapy with a radiation dose of at least 54 Gy. The study focuses on patients who have no progressive disease after this initial treatment and have good performance status. Throughout the trial, participants will be monitored for progression-free survival and other outcomes such as overall survival, objective response, disease control rate, and duration of response over several years. Assessments include imaging reviewed by independent central reviewers and investigators according to standardized criteria. The study involves regular evaluations to track cancer status and safety, with follow-up extending up to approximately nine years to understand long-term effects.

Researchers are evaluating the effectiveness of Pumitamig compared to Pembrolizumab in adults with previously untreated advanced Non-Small Cell Lung Cancer NSCLC who have a PD-L1 expression level of 50% or higher. This Phase 3 randomized, double-blind study focuses on patients with locally advanced or metastatic NSCLC to better understand first-line treatment options. Participants receive either Pumitamig or Pembrolizumab as the study drug, given at specified doses on certain days. The study uses a parallel design with two treatment groups to compare these therapies as first-line options. The study is planned to continue until October 2031, with treatment and follow-up periods extending up to approximately 5 years for overall survival assessments. During the study, participants will have regular assessments to monitor disease progression and response to treatment using criteria like RECIST v1.1. Researchers will evaluate progression-free survival, overall survival, objective response rates, duration of response, disease control rate, and symptom changes related to lung cancer over time. Safety and treatment effects will be closely monitored throughout the study duration.

Researchers are evaluating the relative bioavailability and the impact of food on the absorption of sonrotoclax, a drug given as a tablet for oral suspension, in healthy adult volunteers aged 18 to 60 years. The study aims to compare blood levels of sonrotoclax after administration of the new tablet for oral suspension with those observed using the current sonrotoclax tablet. This Phase 1, open-label, randomized crossover trial helps understand how food affects drug absorption and blood levels. Participants will receive three single oral doses on separate occasions with an 8-day washout period between each dose. The treatments include sonrotoclax tablet for oral suspension given with a high-fat meal, the same tablet after fasting, and the current sonrotoclax tablet with a high-fat meal. Each participant receives all three treatments in random order to compare drug levels under these different conditions. During the study, participants will undergo blood sampling for up to about 20 days to measure drug concentration levels, including total exposure over time and maximum concentration. Researchers will also monitor safety through assessments like vital signs, electrocardiograms, and adverse events for up to approximately 47 days. The study involves multiple visits for dosing and follow-up to ensure participant safety and collect necessary data.

This trial investigates adults aged 45 to 80 with elevated Lipoproteina Lpa levels, who either have existing cardiovascular disease or are at risk for a first cardiovascular event. The study aims to evaluate how lepodisiran, compared to a placebo, affects the amount and type of plaque in the coronary arteries using Coronary Computed Tomography Angiography CCTA. Lipoproteina is a protein carrying cholesterol and is linked to higher heart disease risk. Participants are randomly assigned to receive either lepodisiran or a placebo through subcutaneous injections. The study lasts about 120 weeks, with primary evaluation of changes in noncalcified plaque volume at baseline and at week 104. Secondary measures include changes in fat attenuation index scores, Lpa levels over time, participant feedback on drug administration, and pharmacokinetic analysis. Throughout the study, participants will undergo imaging assessments, blood tests to monitor Lpa levels, and questionnaires regarding treatment experience. The main outcome is the percent change in noncalcified plaque volume in heart vessels. The study includes safety monitoring and continues follow-up to assess effects comprehensively over the study period.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are evaluating a new medicine called NNC6019-0001 for people with transthyretin amyloid cardiomyopathy ATTR-CM, a condition that affects the heart and leads to heart failure. This Phase 3 study compares NNC6019-0001 with a placebo to see if it can reduce the risk of heart-related death and illness. Participants will continue their usual heart treatments throughout the study. Participants will receive either NNC6019-0001 or a matching placebo through intravenous IV infusion. Both groups may also continue their standard heart failure treatments as advised by their doctors. The study is randomized and blinded so that neither participants nor researchers know who receives the medicine or placebo. Treatment and follow-up will last up to about 4 years. During the study, participants will have regular assessments including heart function tests, questionnaires about heart failure symptoms and quality of life, and walking tests to measure physical ability. Researchers will monitor heart-related events such as hospitalizations and urgent visits for heart failure, as well as death from cardiovascular causes. Safety labs and biomarker tests will be done. The main outcome is a combination of cardiovascular deaths and recurrent heart problems measured from the start to the end of the study.