Weston

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are evaluating the safety and effectiveness of a treatment called RD2 Ver.02 compared to a control in managing transsphincteric and intersphincteric anal fistulas. The study focuses on complication rates at 6 months, recurrence at 12 months, and infection rates within 6 months after treatment. This clinical trial is conducted in a blinded, randomized manner to carefully compare outcomes between the two groups. Participants will be randomly assigned to one of two groups. Both groups will have blood drawn for blinding purposes, the fistula will be cleaned and the internal opening sutured closed, followed by a water leak test to ensure sealing. In the treatment group, the patient's own coagulating blood (RD2 Ver.02) will be applied into the fistula tract to help healing, while the control group will receive saline applied in the same way. The treatment is delivered using a semi-flexible cannula to apply the substances inside the fistula. During the study, participants will undergo assessments including blood draws, fistula evaluations, and imaging such as pelvic MRI before enrollment. Researchers will measure healing rates, complication rates, and infection incidence up to 6 months and recurrence at 12 months. Safety and effectiveness will be monitored throughout, with follow-up visits to track outcomes and any adverse events.

Researchers are evaluating a multimodal intervention compared to usual care in adults hospitalized with acute kidney injury (AKI). The study aims to determine if the intervention increases hospital-free days over 90 days and reduces major adverse kidney events and recurrent AKI rates at 180 days. Additionally, the trial investigates improvements in patient-reported outcomes such as quality of life and social support over one year. This is a randomized, pragmatic trial involving 2145 participants assigned to intervention or usual care using a web-based stratified randomization system. The intervention includes three key components: oversight by a study physician or advanced practice provider who conducts discharge assessments and follow-up care recommendations; a nurse navigator who educates patients, coordinates care, monitors symptoms, and supports adherence to medical plans; and a pharmacist who reviews medications via telemedicine, focusing on avoiding nephrotoxins and managing drug interactions. Participants in the usual care group receive written information about kidney disease, nephrotoxins to avoid, and the importance of physician follow-up. Participants will be followed for 90 days primarily to measure hospital-free days, calculated by subtracting hospital days from 90. Secondary outcomes include rates of major adverse kidney events and recurrent AKI at 90, 180, and 365 days, plus patient-reported health outcomes measured at multiple time points. The study involves regular monitoring through assessments, medication reviews, education, and symptom tracking, with total follow-up lasting up to one year to evaluate long-term impacts and safety.

Researchers are evaluating the effect and safety of different doses of a new medicine called NNC0662-0419 in people living with type 2 diabetes. This study compares NNC0662-0419 to a placebo or to semaglutide, an approved medication for type 2 diabetes. The goal is to determine if NNC0662-0419 is effective and safe for treating this condition in a phase 2 dose-finding study. Participants will receive one of the three treatments: NNC0662-0419, semaglutide, or placebo, all given by weekly subcutaneous injections. The treatment assignment is randomized, meaning participants are assigned to their group by chance. The study tests different doses of NNC0662-0419 to find the best dose for treating type 2 diabetes. During the study, researchers will monitor changes in participants' blood sugar levels by measuring glycated haemoglobin (HbA1c) at weeks 16, 28, and 40 compared to the start of the study. Participants will be regularly assessed for safety and treatment effects. The study includes adults aged 18 to 75 years and tracks the impact of the treatments over several months.

Researchers are evaluating how well two new study drugs, CagriSema and cagrilintide, help children and adolescents with excess body weight lose weight. This trial includes participants aged 8 to less than 18 years who have overweight or obesity. The study is designed in two parts: a main study and an extension study. The main study compares CagriSema, cagrilintide, semaglutide (an already approved drug), and placebo, with treatments assigned randomly. Participants receiving semaglutide will not continue to the extension study. The total time in the main study is about 1 year and 6 months, while those in the extension study may participate for up to about 4 years and 10 months. Participants in the main study will receive one of the four treatments by subcutaneous injection. In the extension study, participants will receive either CagriSema or cagrilintide. The study drugs are monitored closely for safety, and participants may experience side effects. The study compares these new treatments to a placebo and an existing approved drug to better understand their effects on weight management in young people. During the study, researchers will measure changes in body mass index (BMI) from baseline to week 68 as the primary outcome. Participants will undergo various assessments including laboratory tests and physical evaluations. The study tracks adherence to treatment and monitors safety throughout the study period. This comprehensive approach aims to provide detailed information about the efficacy and safety of these medications for managing weight in children and adolescents.

Researchers are evaluating KB707, a genetically modified herpes simplex virus type 1 vector designed to activate the immune system against advanced solid tumors in the lungs. This Phase 1/2 open-label study aims to assess the safety, tolerability, preliminary effectiveness, and immune response triggered by KB707 in adults with advanced lung cancers who have exhausted or cannot tolerate standard treatments. The study includes participants with non-small cell lung cancer (NSCLC) and other advanced solid tumors affecting the lungs. Participants receive KB707 inhaled through a nebulizer to deliver the therapy directly into the lungs. In the initial dose escalation phase, KB707 was given weekly for three weeks, then every three weeks as monotherapy. Following dose selection, the expansion phase continues evaluating this regimen. Additional study arms combine inhaled KB707 every two weeks with Keytruda (an immune checkpoint inhibitor) given every six weeks, or with docetaxel chemotherapy every three weeks. Treatment continues until disease progression, unacceptable side effects, or other specified reasons for stopping. Throughout the study, participants undergo regular evaluations including tumor scans to measure response, safety monitoring for adverse events, and immune system assessments. The primary outcome focuses on the safety and tolerability of inhaled KB707 over up to 36 months. Participants are closely followed to understand how the treatment affects tumor control and immune activity, with ongoing monitoring until treatment discontinuation or study completion.

Researchers are studying KB707, a genetically modified herpes simplex type 1 virus designed to trigger an immune response against tumors. This Phase 1/2 open-label trial is focused on adults with locally advanced or metastatic solid tumors, including advanced melanoma, especially those who have progressed on or cannot tolerate standard treatments. The study also explores the safety, tolerability, preliminary effectiveness, and immune effects of KB707 when combined with immunotherapy drugs for melanoma. Participants receive KB707 through injections directly into tumors approximately every three weeks during the dose escalation and initial expansion phases, which are now closed to new participants. In later phases, those with advanced melanoma receive biweekly KB707 injections combined either with Opdualag every four weeks or Keytruda every six weeks. Treatment continues until disease progression, unacceptable side effects, worsening symptoms, maximum response, patient choice, investigator decision, or study termination. During the study, participants undergo evaluations including assessments of adverse and serious adverse events for up to 36 months. Researchers monitor safety, tolerability, immune response, and preliminary efficacy through clinical exams, imaging, and laboratory tests. The goal is to understand how KB707 alone and with immunotherapy acts in treating advanced solid tumors and melanoma over the treatment and follow-up periods.

Researchers are evaluating efruxifermin (EFX) in adults aged 18 to 80 who have compensated cirrhosis caused by nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of EFX in improving liver health and delaying disease progression in this population. The study focuses on subjects with advanced liver fibrosis (stage 4) but without liver decompensation. Participants are randomly assigned to receive either efruxifermin or a placebo, both administered by subcutaneous injection. The study includes two cohorts: Cohort 1 requires biopsy confirmation of liver fibrosis and specific metabolic features, while Cohort 2 allows biopsy or non-invasive diagnosis. Treatment and observation continue over an extended period to evaluate changes in liver fibrosis and clinical events. During the study, researchers will monitor the time until significant clinical events such as disease progression or liver decompensation occur, with a follow-up of up to five years. For Cohort 1, the proportion of participants showing improvement in fibrosis without worsening steatohepatitis will be assessed at 96 weeks. Participants will undergo regular evaluations including clinical assessments and laboratory tests to track liver function and safety throughout the study period.

Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.

Researchers are evaluating the effectiveness and safety of combining inavolisib with a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole compared to placebo plus CDK4/6i and letrozole. This study focuses on participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. It aims to assess treatment outcomes in the first-line setting for this specific breast cancer type. Participants will be assigned to receive either oral inavolisib once daily or a matching oral placebo once daily. All participants will also receive a CDK4/6 inhibitor on either Days 1-21 or Days 1-28 of each 28-day cycle, along with daily oral letrozole. This randomized, double-blind study will compare these two treatment combinations to monitor differences in disease progression and safety. Throughout the study, researchers will evaluate progression-free survival from the time of randomization until disease progression or death, up to 7 years. Participants will undergo assessments including tumor measurements by RECIST criteria, performance status evaluations, and monitoring of blood and organ function before treatment begins. Safety and efficacy will be closely observed during treatment, aiming to provide detailed long-term data on the study therapies.