Ngo Quyen

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

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 effects of EYU688, an oral drug, compared with a placebo in patients with dengue fever. The study aims to understand how EYU688 influences dengue viral load, fever clearance time, and clinical symptoms. This randomized, participant- and investigator-blinded, placebo-controlled trial includes two patient groups based on different pharmacokinetic sampling schedules. Participants will receive either EYU688 or a matching placebo orally. The study runs two cohorts in parallel one with intensive pharmacokinetic sampling and another with sparse sampling. Treatment and assessments occur from the start of dosing through Day 15, with additional safety monitoring up to Day 35. The study measures drug concentration levels and viral load changes over time. Throughout the study, participants will undergo evaluations including viral load tests, fever monitoring, blood tests for blood cells and liver enzymes, and assessments for dengue severity. Safety and adverse events are recorded up to Day 35. The primary outcome is viral load reduction at 48 hours after treatment begins. Participation lasts until study completion, expected by July 2027.

Researchers are studying children aged 6 to less than 12 years with asthma to compare the effects and safety of QMF149 a combination of indacaterol acetate and mometasone furoate with budesonide. This Phase 3, double-blind, randomized, two-period, crossover study aims to determine if QMF149 is superior to budesonide in improving lung function and asthma control in this pediatric population. Participants undergo a total study duration of up to 37 weeks, including screening and run-in periods, two 12-week treatment phases where they receive either QMF149 7540 mcg once daily or budesonide 200 mcg once daily via Breezhaler, separated by a 3-week washout period with fluticasone propionate. Following treatment periods, a 4-week safety follow-up occurs during which patients return to standard care. Throughout the study, children and their parentslegal guardians attend scheduled visits for assessments including lung function tests FEV1, asthma control questionnaires, peak expiratory flow rate measurements, and rescue medication use tracking. Safety is monitored by recording adverse events up to 30 days after the last dose. The study evaluates changes from baseline in lung function and asthma control after each treatment period, with participants supported in completing diaries and attending visits over the 37-week timeline.

Researchers are evaluating AZD0292, a bispecific IgG1k monoclonal antibody, for preventing exacerbations in bronchiectasis patients who are chronically colonized with Pseudomonas aeruginosa PsA. This Phase IIb study compares two dosage regimens of AZD0292 administered intravenously with placebo in participants aged 12 years and older. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent pulmonary exacerbations due to chronic PsA colonization, which negatively affects lung function, quality of life, and survival. Additionally, patients with cystic fibrosis bronchiectasis colonized with PsA are included as an exploratory group. Participants will receive either high-dose or low-dose AZD0292 starting on Day 1 via IV infusion, or placebo administered similarly. Subsequent doses will follow a schedule of assessments. This randomized, double-blind, placebo-controlled, parallel study aims to assess the efficacy, safety, and pharmacokinetics of AZD0292 over a variable follow-up period ranging from a minimum of 28 weeks up to 52 weeks. The trial also includes monitoring for adverse events and immune responses to the treatment. During the study, participants will undergo evaluations including lung function tests, quality of life questionnaires, and monitoring of exacerbation rates. Blood samples will be collected to measure drug concentration and antibody development. Safety assessments will continue through the treatment period and for up to 24 weeks after the last dose. The primary outcome is the annualized rate of exacerbations over the follow-up time, and secondary measures include severe exacerbation rates, time to first exacerbation, and changes in quality of life scores. Total participation spans from screening through the treatment and follow-up phases.

Researchers are evaluating the efficacy and safety of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease COPD who are receiving inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on adults aged 40 to 80 years who have experienced multiple COPD exacerbations in the year prior to enrollment. The trial aims to assess tezepelumabs impact compared to placebo on COPD exacerbations and lung function. Participants will receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. Treatment duration ranges from a minimum of 52 weeks to a maximum of 76 weeks. Following the treatment period, participants will undergo a 12-week off-treatment safety follow-up to monitor any lasting effects. Throughout the study, participants will be regularly assessed for COPD exacerbations, lung function changes measured by forced expiratory volume FEV1, and quality of life using questionnaires such as the St. Georges Respiratory Questionnaire and COPD Assessment Test. Blood samples will be collected to measure drug levels and immune responses. Safety and efficacy will be closely monitored, with total participation lasting up to approximately 88 weeks including follow-up.

This trial is for adults who have had an acute ischemic stroke caused by a blood clot blocking a brain vessel. It focuses on people whose stroke occurred or was discovered more than 4.5 hours ago, including those who woke up with stroke symptoms. The study aims to find out if the medicine tenecteplase helps recovery when given after this 4.5-hour window, compared to standard medical care. Tenecteplase is already used within 4.5 hours after stroke onset, but this study tests its effect when given later. Participants are randomly assigned to one of two groups one receives a single injection of tenecteplase into a vein, and the other receives the usual standard treatment. Both groups have an equal chance of receiving either treatment. The study lasts about three months, starting with approximately one week of hospital stay. During the study, participants have seven clinical examinations or visits, with the final two visits conducted remotely from home to allow for easier participation. Throughout the study, doctors regularly assess participants recovery using a scale that measures disability and dependence in daily activities. They also monitor overall health and record any side effects. The main outcome measured is the level of recovery 90 days after treatment, comparing the two groups. This includes neurological improvement, bleeding events, and survival over the study period.

Infants commonly experience functional gastrointestinal symptoms such as colic, excessive gas, regurgitation, constipation, or loose stools, which can distress families and may be linked to an imbalance in the gut microbiome. This research evaluates whether the multistrain probiotic BioAmicus Complete can improve these caregiver-reported symptoms in infants aged 0 to 24 months and assesses its safety in this group. The study also explores changes in stool microbiome composition and diversity over time. Participants are randomly assigned to one of two groups one group receives BioAmicus Complete oral probiotic drops along with usual care for 42 days, while the other group receives standard clinical management without probiotic supplementation. Caregivers administer the probiotic drops per protocol, and use of other probiotic products is avoided during the study. Concomitant medications and routine care are allowed at the investigators discretion. Adherence to the probiotic regimen is recorded. During the study, caregivers complete questionnaires and diaries to report gastrointestinal symptoms and quality of life. Researchers monitor growth parameters like weight and length, track health care use and antibiotic exposure, and collect stool samples for microbiome analysis. Safety is assessed by recording adverse events. The primary measure is the change in Infant Gastrointestinal Symptom Questionnaire IGSQ total score from baseline to day 42. Secondary measures include stool frequency and consistency, symptom domains, and overall safety outcomes. The study runs until May 2026.

Poor appetite is common in young children and can affect their nutrient intake and eating behavior. This research aims to evaluate whether a zinc-containing oral supplement called Biolizin syrup can improve eating behavior in children aged 6 to 36 months who have poor appetite without a clear medical cause. The study is randomized and controlled, focusing on changes in feeding difficulty and eating behavior over 42 days. Children in the study receive either Biolizin syrup, taken once or twice daily according to age-based dosing for 42 days along with caregiver counseling on responsive feeding, or they receive only the caregiver counseling without the supplement. Caregivers attend clinic visits at Day 0, Day 7, Day 21, and Day 42 to receive counseling, report feeding behavior, and monitor adherence. Use of other zinc products or appetite stimulants is not allowed. Participants undergo measurements of weight and height at each visit, and caregivers complete validated questionnaires on feeding difficulties and eating behavior. Safety is monitored through adverse event review and laboratory tests at baseline and Day 42, including possible serum zinc levels. The main outcome measured is the change in feeding difficulty score from the start to Day 42. Secondary outcomes include changes in eating behavior subscales, growth indices, serum zinc, and overall safety throughout the study.