Rotorua

Researchers are studying a medicine called enlicitide to reduce low-density lipoprotein cholesterol (LDL-C) in adults with high cholesterol (hyperlipidemia). This trial aims to find out if taking enlicitide together with rosuvastatin, a standard cholesterol-lowering drug, works better than a placebo in lowering LDL-C levels. The study is a Phase 3 trial that is randomized, double-blind, and placebo-controlled to ensure accurate and unbiased results. Participants will receive oral tablets of enlicitide or placebo along with oral capsules of rosuvastatin or placebo. The study compares the effect of enlicitide plus rosuvastatin against placebo to evaluate their impact on LDL-C. The treatment period lasts 8 weeks, during which participants take their assigned medications as directed. During the study, researchers will measure the average percent change in LDL-C from the start of the trial to week 8. Participants will be monitored for safety and any side effects throughout the study. The total participation time includes screening, treatment, and follow-up assessments to evaluate the medicines' effects and safety in adults aged 18 to 64 with hyperlipidemia.

Researchers are investigating the safety, tolerability, and how the body processes and responds to various doses of ARO-ALK7 in adults with obesity, including those with and without Type 2 Diabetes Mellitus (T2DM). This Phase 1/2a study includes a dose-escalation design and aims to understand the effects of single and multiple doses of ARO-ALK7 alone or combined with tirzepatide. Participants will receive ARO-ALK7 or a placebo through subcutaneous injections. The study consists of two parts: Part 1 evaluates single and multiple doses in adults with obesity without T2DM, and Part 2 assesses multiple doses in adults with obesity both with and without T2DM, either as monotherapy or combined with tirzepatide. The dosing will be escalated to understand safety and drug behavior. During the study, participants will be closely monitored for treatment-emergent adverse events up to Day 253, marking the end of the study. Researchers will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics through regular assessments. The total participation duration covers dosing and follow-up to assess outcomes and monitor safety throughout the study period.

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 BGB-26808, alone or combined with tislelizumab, in participants with advanced solid tumors in an open-label, multicenter, nonrandomized Phase 1 study. This study aims to find the recommended dosing for BGB-26808 while assessing its safety, tolerability, pharmacokinetics, and early antitumor activity. Participants include those with advanced, metastatic, unresectable, or locally advanced tumors who may have limited treatment options or no prior therapy targeting HPK1. Participants receive BGB-26808 orally once daily as a tablet. Tislelizumab, when used, is given by intravenous infusion. Chemotherapy may also be administered following local guidelines or prescribing information. The study includes dose escalation and dose expansion phases to determine the maximum tolerated dose, maximum administered dose, and the recommended dose for further study. During the study, participants undergo regular monitoring for adverse events and serious adverse events up to about 12 months after dosing or until starting new anticancer therapy. Effectiveness is measured by overall response rate around 6 months. Researchers will collect tumor tissue samples, assess organ function, and evaluate performance status. Participants are followed closely with safety checks and evaluations of treatment response throughout the study duration.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 years with moderate to severe chronic obstructive pulmonary disease (COPD) who have type 2 inflammation and frequent exacerbations. This Phase 3 study aims to assess the safety and effectiveness of depemokimab when added to optimized inhaler therapy compared to placebo in participants whose COPD is uncontrolled despite current treatment. Participants must have an elevated blood eosinophil count and a history of COPD symptoms and exacerbations. Participants will receive depemokimab, a sterile liquid drug, or a placebo consisting of a sterile 0.9% sodium chloride solution. The treatments are administered as an add-on to their usual inhaler therapies, which include inhaled corticosteroids, long-acting muscarinic antagonists, and long-acting beta2-adrenergic agonists. The study is randomized, double-blind, placebo-controlled, and takes place across multiple centers. Treatment duration and detailed dosing schedules are not specified but participants are monitored up to 104 weeks. Throughout the study, participants will be monitored for the annual rate of moderate to severe COPD exacerbations. Researchers will also assess safety and other clinical outcomes related to lung function and COPD symptoms. Participants will have regular visits for evaluation of their disease status, treatment adherence, and any side effects. The total duration of participation includes baseline screening and follow-up visits over the study period to ensure comprehensive data collection for efficacy and safety analysis.

Researchers are evaluating the safety and effectiveness of an investigational drug called ficerafusp alfa combined with pembrolizumab compared to placebo with pembrolizumab in adults with PD-L1-positive recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). This study includes both Phase 2 and Phase 3 parts. Ficerafusp alfa targets two cancer-related proteins, EGFR and TGF-beta, which play roles in tumor growth and spread. The goal is to find the best dose and then compare treatment outcomes between groups. In Phase 2, participants will be randomly assigned to one of three groups: ficerafusp alfa 1500 mg weekly plus pembrolizumab every three weeks, ficerafusp alfa 750 mg weekly plus pembrolizumab every three weeks, or placebo weekly plus pembrolizumab every three weeks. Phase 3 will randomize participants to the selected ficerafusp alfa dose plus pembrolizumab or placebo plus pembrolizumab. Treatments will continue as scheduled, and safety, tolerability, and treatment responses will be closely monitored throughout. Participants will undergo assessments including scans to measure tumor response using RECIST 1.1 criteria, safety evaluations for side effects, and survival tracking. Safety monitoring includes checking for treatment-related adverse events up to 30 days after treatment ends and serious events up to 90 days afterward. The study will follow participants for approximately one year in Phase 2 and up to three years in Phase 3 to evaluate treatment effectiveness and overall survival.

Researchers are evaluating new treatments for acute hypoxemic respiratory failure (AHRF), a serious condition affecting millions worldwide and often requiring mechanical ventilation or extracorporeal life support. This adaptive platform trial includes multiple domains that assess different therapies across a range of patient severity and investigational phases, from early mechanistic studies to full clinical trials. The study uses advanced statistical methods to efficiently test interventions focusing on mechanical ventilation, extracorporeal support, drugs, and medical devices. Participants may receive various interventions depending on the domain, including ultra-protective ventilation using VV-ECMO, lung-protective ventilation, driving pressure-limited ventilation, lung- and diaphragm-protective ventilation with sedation, corticosteroid treatments, fludrocortisone, nebulized furosemide, or inspiratory muscle training. Some domains also study ventilation strategies during extracorporeal life support or collect observational data. Treatments are delivered according to randomized assignments, sometimes involving specialized devices or adjusted ventilator settings. During the study, participants undergo assessments including physiological and biological measurements, monitoring of ventilation targets, adherence to protocols, and survival outcomes up to 60 days. Recruitment feasibility and barriers are tracked over years at multiple sites. The trial collects data on ventilator-free days, mortality, advanced respiratory support-free days, and protocol adherence. Safety and effectiveness are regularly evaluated through Bayesian adaptive analyses, with total enrollment periods ranging from months to years depending on the domain.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.