Wardha

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are evaluating the efficacy and safety of two different dose regimens of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage F2 or F3. This Phase 3 study aims to better understand how pegozafermin may impact liver fibrosis and steatohepatitis in this population. Participants will receive subcutaneous injections of either one of two pegozafermin regimens or a matched placebo. These treatments are given in parallel groups, and participants are randomly assigned to one of the study groups. The study compares the effects of pegozafermin on liver fibrosis and steatohepatitis over a treatment period that includes evaluations up to 52 weeks and monitoring for disease progression up to 5 years. During the study, participants will be monitored through biopsies and blood tests to assess liver fibrosis improvement, resolution of steatohepatitis, changes in liver enzyme levels, and enhanced liver fibrosis scores. Safety and disease progression are also tracked throughout the study period. The total participation duration includes treatment and long-term observation to evaluate outcomes and any potential changes in liver health.

Researchers are evaluating the efficacy and safety of pegozafermin in adults with compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis MASH, previously known as nonalcoholic steatohepatitis NASH. This study focuses on participants with biopsy-confirmed advanced liver fibrosis stage F4 due to MASH. The research aims to understand how pegozafermin affects liver health over time compared to a placebo. Participants will receive either pegozafermin or a matched placebo through subcutaneous injections. The study follows a randomized, parallel design with quadruple masking to ensure unbiased results. The treatment period extends up to 24 months, with additional long-term follow-up lasting up to five years to assess disease progression and liver fibrosis regression. During the study, participants will undergo various assessments including measurements of liver fibrosis, disease progression through clinical events, and liver function tests such as alanine aminotransferase ALT levels. Tools like Enhanced Liver Fibrosis ELF score and FibroScan Vibration-controlled Transient Elastography VCTE will be used to monitor liver condition up to 60 months. Safety and efficacy will be closely monitored throughout the study period, which may last up to seven years in total.

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.

This research aims to determine whether umbilical cord milking compared to early cord clamping can reduce in-hospital death rates in non-vigorous preterm infants born between 30 and 34 weeks of gestation. Prematurity is a leading cause of death in young children worldwide, especially in low-resource countries, and this study focuses on a simple intervention that might improve survival in this vulnerable group. The trial compares two methods used immediately after birth milking the umbilical cord four times before clamping versus clamping the cord early within 60 seconds. Milking involves pushing blood through the cord into the infant and is done quickly by the delivery team. About 800 preterm infants will be randomly assigned to one of these two approaches in a multicenter, cluster-randomized crossover design. Participants will be monitored in the hospital from birth until discharge or death, up to 12 weeks. Researchers will track mortality and various health outcomes such as hemoglobin levels, infections, brain hemorrhages, need for blood transfusions, jaundice treatment, and length of hospital stay. This study aims to provide important evidence on the safety and effects of umbilical cord milking in preterm newborns who need immediate resuscitation.

Researchers are conducting a Phase 1, open-label, dose escalation study to assess the safety, pharmacokinetics PK, and pharmacodynamics PD of an oral drug called AUR112 in patients with relapsed advanced lymphomas. This first-in-human trial aims to find safe and tolerable doses of AUR112 for future studies. The study is led by Aurigene Discovery Technologies Limited and focuses on patients with relapsed or refractory non-Hodgkin lymphoma NHL, chronic lymphocytic leukemia CLL, or Hodgkin disease who have exhausted other effective therapies. Participants will receive AUR112 once daily at increasing dose levels ranging from 100 mg to 1200 mg. The dose escalation follows a classic 33 design, where safety and biological activity data guide dose increases. The study will continue increasing doses until safety limits are reached or biologically active doses are identified. This approach helps determine the most appropriate doses for future clinical trials. During the study, participants will be closely monitored for dose-limiting toxicities and treatment-related adverse events over the first 28 days cycle 1. Researchers will also measure various PK parameters like maximum concentration, time to maximum concentration, and area under the curve on specific days. Assessments include laboratory tests, physical exams, and safety evaluations. The study will help identify doses for further research while ensuring participant safety throughout the trial period.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled study to evaluate lumateperone as an additional treatment for adults with Major Depressive Disorder MDD who have not responded well to ongoing antidepressant therapy. The study focuses on patients diagnosed with MDD according to DSM-5 criteria, including those with psychotic features, who have experienced an inadequate response to at least two antidepressant treatments during their current major depressive episode. Participants will be randomly assigned to receive either lumateperone 42 mg capsules or matching placebo capsules taken orally once daily for six weeks during the double-blind treatment period. The trial includes three periods a screening period of up to two weeks to assess eligibility, the six-week treatment period, and a one-week safety follow-up period after the last dose to monitor participant safety. During the study, participants will undergo assessments including depression severity ratings using the Montgomery-Asberg Depression Rating Scale and the Clinical Global Impression Scale. Researchers will monitor symptoms, treatment adherence, and safety throughout the treatment and follow-up periods. Total participation spans approximately nine weeks, covering screening, treatment, and safety monitoring.