Vienna

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation CIC. This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

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.

This clinical trial is investigating the net clinical benefit of finerenone compared to a fixed-dose combination of extended-release torsemide and spironolactone in adult patients with hypertension and proteinuric chronic kidney disease. It is a randomized, parallel, two-arm study designed to evaluate these treatments specifically in patients who have certain kidney function and blood pressure measures. The study is sponsored by Sarfez Pharmaceuticals, Inc. and focuses on improving clinical outcomes in this population. Participants will be randomly assigned to one of two groups one group will receive a once-daily fixed-dose combination tablet containing 24 mg of extended-release torsemide and 30 mg of spironolactone, while the other group will continue stabilized doses of loop diuretics up to 80 mg furosemide or equivalent combined with 10 mg daily of finerenone. The treatment phase will last at least 12 weeks, during which blood pressure, urinary albumin-to-creatinine ratio, and serum potassium levels will be closely monitored to compare the treatments clinical benefits. Throughout the study, participants will undergo regular assessments including blood pressure measurements, laboratory tests for kidney function and potassium levels, and monitoring for any adverse events. The primary outcomes focus on reductions in systolic blood pressure, urinary albumin-to-creatinine ratio, and serum potassium after 12 weeks of treatment. Participants will be followed until the studys completion in 2026, with safety and adherence carefully tracked to ensure accurate evaluation of the treatment effects.

Researchers are evaluating the real-world use and safety of BRIUMVI4 ublituximab-xiiy in adults with relapsing multiple sclerosis RMS. The study aims to understand the safety, effectiveness, and treatment experience of participants prescribed this medication outside of controlled clinical trials. This observational study is sponsored by TG Therapeutics, Inc. and focuses on patients receiving routine care with BRIUMVI4. Participants in this study will receive BRIUMVI4 through intravenous infusion as prescribed for RMS treatment. The study includes participants who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. No placebo or other interventions are involved, and the study observes the treatment as it is given in real-world medical settings. During the study, participants will be monitored for up to 96 weeks to assess their annualized relapse rate ARR. Researchers will also track adverse events, serious adverse events, and infusion-related reactions at each infusion. Participant safety and treatment experience will be observed through regular clinical assessments and data collection, with the study lasting until April 2032.

Researchers are evaluating a new medication called CX11 for adults with type 2 diabetes who have not achieved adequate blood sugar control despite taking a stable dose of metformin, with or without an SGLT2 inhibitor, for at least 90 days. This phase 2 study is randomized, double-blind, and placebo-controlled, aiming to determine the safety and effectiveness of different doses of CX11 in comparison to placebo. Participants will be randomly assigned to one of six groups, each receiving a different dose of CX11 40 mg, 80 mg, 120 mg, 160 mg, or 200 mg or a matching placebo. The medication is taken orally once daily for 24 weeks, followed by a 2-week safety follow-up period. The study is conducted across multiple medical centers and neither participants nor staff will know the group assignments during the trial. Throughout the study, participants will undergo regular assessments including blood tests to measure changes in HbA1c a marker of blood sugar control, fasting plasma glucose, body weight, and blood pressure. Continuous glucose monitoring will track time spent in the target glucose range. Safety is monitored by recording adverse events and measuring plasma drug levels at specified intervals. The total participation period is approximately 26 weeks.

Researchers are evaluating RTN-001, a drug, to see if it can reduce high blood pressure in adults with uncontrolled hypertension who are already taking multiple blood pressure medications. This Phase 2b, randomized, double-blind study involves adults aged 18 to 70 years with blood pressure above specified thresholds despite treatment with at least two antihypertensive drugs. The study compares RTN-001 to a placebo to understand its effect on blood pressure and monitor safety. Participants will undergo a screening period up to 14 days to confirm eligibility, followed by a 14-day single-blind run-in period to test compliance and baseline blood pressure measurement. Then, around 280 patients will be randomly assigned to one of four groups to receive daily oral doses of RTN-001 at 15 mg, 30 mg, 45 mg, or placebo for 12 weeks. Blood pressure and laboratory tests will be performed at multiple visits, and ambulatory blood pressure monitoring will occur twice during treatment. After treatment ends, a follow-up phone call will assess any side effects or medication changes. During the study, participants will visit the clinic approximately every two weeks for blood pressure checks, blood sampling, and other assessments. They will keep a diary of symptoms and medications taken. Researchers will measure changes in systolic and diastolic blood pressure using office and ambulatory methods, evaluate drug levels and safety markers, and monitor adverse effects. The total participation includes screening, run-in, treatment, and a follow-up phone call about two weeks after treatment ends.

Researchers are studying the safety and effects of two drugs, PF-08653945 and PF-08653944, given alone or together for weight loss in adults with overweight or obesity. This Phase 2b trial compares these drugs to a placebo to better understand their impact on body weight over time. The study is designed to evaluate different doses and combinations of these drugs to find the most effective approach. Participants receive subcutaneous injections of either PF-08653945 alone, PF-08653945 combined with PF-08653944, PF-08653944 alone, or a placebo. The study uses a randomized, double-blind design with multiple cohorts receiving different drug combinations or placebo. Treatments are administered as injections under the skin over a planned period of 48 weeks, with follow-up extending to 70 weeks to monitor safety and outcomes. During the study, participants will have their body weight measured at baseline and regularly through Week 48 and Week 60 to track changes. Researchers will assess the percentage of weight loss and monitor any treatment-emergent or serious adverse events up to Week 70. Participants will attend scheduled visits for injections and evaluations throughout the trial, which lasts for over a year in total.

Researchers are evaluating the safety of an investigational varicella vaccine VNS Vaccine compared to an approved varicella vaccine called Varivax. This study focuses on healthy children aged 12 to 15 months who have not had chickenpox or received any varicella vaccine before. The goal is to understand how well the new vaccine is tolerated in this young population. Participants will receive one dose of either the investigational varicella vaccine or the marketed Varivax vaccine, both given by injection under the skin. Along with the varicella vaccine, each child will also receive one dose each of measles, mumps, and rubella MMR vaccine, hepatitis A vaccine, and a pneumococcal conjugate vaccine PCV, which may be PCV 13, Vaxneuvance, or PCV 20, depending on availability and national recommendations. All vaccines are given on the first day of the study. During the study, parents will record any side effects their child experiences, particularly those related to the injection site or systemic symptoms like fever, for up to 43 days. Researchers will monitor any adverse events, including serious and medically attended events, for up to 181 days after vaccination. This helps assess the safety and tolerability of the investigational vaccine over a period of about six months.

Researchers are evaluating the effectiveness of remibrutinib compared to dupilumab as add-on treatments for adults with moderate to severe chronic spontaneous urticaria CSU that is not well controlled by second generation H1-antihistamines sgH1-AH. This Phase 3b, multi-center, randomized, double-blind, double-dummy study focuses on early treatment effects within 4 weeks. The study addresses the need for better management of CSU symptoms such as hives and itch. Participants will be assigned to one of two treatment groups one group will receive remibrutinib tablets twice daily plus placebo injections, while the other group will receive dupilumab injections with matching placebo tablets. Both groups continue their stable background therapy of sgH1-AH daily. The study includes a screening period up to 4 weeks, a 12-week core double-blind treatment period, and an optional 12-week open-label extension where all participants may receive remibrutinib if it is not commercially available. After treatment, safety follow-up occurs for up to 12 weeks, with phone calls and possible site visits. Participants will be monitored through regular assessments including symptom severity scores, urticaria activity scores, and daily diaries. Safety follow-up includes phone calls and visits depending on treatment continuation. The main outcome is the change in weekly urticaria activity score at Week 4. Other measures include severity of hives and itch at Weeks 1 and 4. Total study participation may last up to 24 weeks, including optional extension and follow-up phases.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 with mild to severe Alzheimers Disease who experience moderate to severe psychosis related to this condition. This Phase 3 trial aims to study KarXT compared to a placebo to better understand its impact on psychotic symptoms associated with Alzheimers. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses on certain days. The study lasts up to 14 weeks, during which changes in psychosis symptoms, as measured by the Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score, will be closely monitored. Additional assessments include cognitive tests and monitoring for side effects. During the trial, participants will undergo regular evaluations including symptom ratings, cognitive tests such as the Mini-Mental State Examination, laboratory tests, and safety monitoring. Researchers will track any adverse events and changes in mental and physical health. The study aims to provide detailed information about how KarXT affects psychosis and cognition in Alzheimers disease over the treatment period.