Uzhhorod

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

This research aims to evaluate the efficacy and safety of duvakitug in people with moderately to severely active Ulcerative Colitis UC. It is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study that includes participants aged 16 to 80 years. The study is sponsored by Sanofi and focuses on assessing clinical remission and other important health outcomes in UC. Participants receive subcutaneous injections of duvakitug or placebo according to protocol. The study includes a 40-week Pivotal Maintenance Sub-Study followed by a 240-week Open-Label Extension OLE Sub-Study for those who continue. Those not entering the OLE will have a 45-day follow-up after the maintenance period. There are up to 32 on-site visits in total, with 21 visits during the maintenance phase and 11 during the extension. During the study, participants will have clinical assessments including endoscopy to evaluate remission and mucosal healing, symptom tracking such as bowel urgency and abdominal pain, and quality of life questionnaires. Safety is monitored through adverse event reporting and blood tests for drug concentrations and antibodies. The primary outcome is the proportion of participants achieving clinical remission by the modified Mayo Score at Week 40, with follow-up continuing up to 286 weeks for some participants.

Researchers are evaluating the effects of combining baxdrostat with dapagliflozin versus baxdrostat with a placebo on albuminuria in adults with chronic kidney disease CKD and high blood pressure. This Phase IIb, randomized, multicenter, double-blind study includes participants aged 18 and older, with or without type 2 diabetes and with or without prior SGLT2 inhibitor treatment. The goal is to understand how these treatments affect kidney function and safety in this population. Participants will be randomly assigned to receive either a daily dose of baxdrostat combined with dapagliflozin or baxdrostat with a placebo matching dapagliflozin. Before randomization, some participants may go through an optional pre-screening and a washout period if they are currently taking an SGLT2 inhibitor. The study includes stratification based on diabetes status to balance groups. Throughout the study, participants will undergo assessments including measurements of urine albumin-to-creatinine ratio UACR to evaluate changes in albuminuria from baseline over up to 12 weeks. Safety and other health parameters such as blood pressure, potassium, and sodium levels will also be monitored. Study completion is defined by finishing all scheduled procedures, and the study continues until the last participant completes their last visit globally.

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 combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are studying baricitinib to see if it can help preserve beta-cell function in children and adults aged 1 to 35 years who have been newly diagnosed with type 1 diabetes. This Phase 3 study aims to evaluate the treatments impact on preserving insulin production shortly after diagnosis. Participants will be followed for about 60 weeks to assess changes in key diabetes-related measures. Participants will be randomly assigned to receive either baricitinib or a placebo, both taken orally. The study compares these two groups to evaluate the effects of baricitinib on beta-cell function. The main measurement is the change in C-peptide area under the curve over 52 weeks, which indicates insulin production. Additional outcomes include changes in blood sugar control, insulin use, hypoglycemia events, and other health indicators. During the study, participants will attend visits for assessments and monitoring over approximately 60 weeks. Tests will include blood measurements like C-peptide and hemoglobin A1c, insulin dose tracking, and health surveys. Safety and drug levels will be monitored. Researchers will use these data to understand if baricitinib can help maintain beta-cell function in people newly diagnosed with type 1 diabetes.

Researchers are evaluating the safety, how the body processes the drug, and the effects of calderasib alone and in combination with other therapies in adults with advanced solid tumors that have a specific genetic mutation called KRAS G12C. This study focuses on participants with measurable disease and adequate organ function who have this mutation confirmed by tissue or blood testing. It is a Phase 1 trial aiming to understand treatment tolerability and effectiveness in this patient group. Participants receive different study treatments depending on their assigned group. Some receive daily oral escalating doses of calderasib up to 800 mg until the disease progresses or treatment stops. Others receive calderasib combined with pembrolizumab infusions every 21 days for up to about 24 months, sometimes along with other chemotherapy drugs like carboplatin, pemetrexed, cetuximab, oxaliplatin, leucovorin, and 5-fluorouracil, given according to standard dosing schedules. Dosing may be adjusted based on safety. The study includes several treatment arms with different combinations. During the study, participants undergo regular safety monitoring, including tracking dose-limiting toxicities and adverse events over approximately 56 months. Researchers measure treatment effects, such as tumor response and duration, and study how calderasib behaves in the body through blood tests at designated times during treatment cycles. Participants will be followed through multiple cycles lasting 3 or 4 weeks depending on the arm, with assessments continuing for up to about 56 months to capture long-term effects and safety.