Vadodara

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

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 effectiveness and safety of Datopotamab Deruxtecan Dato-DXd with or without Durvalumab compared to investigators choice chemotherapy combined with Pembrolizumab in patients with PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer TNBC. This Phase III, randomized, open-label, international study aims to determine if Dato-DXd with Durvalumab can improve progression-free survival and overall survival while assessing quality of life impacts in this patient population. Participants are assigned to one of three groups Dato-DXd with Durvalumab, investigators choice chemotherapy paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin combined with Pembrolizumab, or Dato-DXd alone. All study drugs are given by intravenous infusion. The study includes stratification by geographic region, disease-free interval, and prior PD-1PD-L1 treatment. Treatment continues with monitoring up to about 33 months for progression-free survival and safety, with some outcomes followed up to 64 months. Throughout the study, participants undergo assessments including imaging to measure tumor response using RECIST criteria, laboratory tests, and questionnaires to evaluate symptoms and quality of life. Researchers monitor time to disease progression, overall survival, response duration, and safety outcomes. Follow-up includes evaluation of subsequent therapies and pharmacokinetics. The total participation duration can be up to several years to capture long-term outcomes.

Researchers are evaluating a potential new medicine called CDR132L to understand its effects on the structure and function of the heart in people living with heart failure. The study focuses on participants with heart failure who have reduced or mildly reduced ejection fraction and left ventricular hypertrophy. This research is a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial aiming to assess safety and efficacy in this population. Participants will receive an intravenous infusion of either CDR132L or a placebo once every four weeks for 48 weeks. Alongside this, all participants will continue their individually tailored guideline-directed standard of care therapy for heart failure. The studys main phase covers these 48 weeks of treatment, followed by monitoring adverse events up to week 60. During the approximately 60-week study, participants undergo evaluations including echocardiography and blood tests measuring biomarkers like microRNA-132-3p and NT-proBNP. Researchers will track changes in heart structure and function, adverse events, and safety throughout the study. The primary outcome focuses on changes in normalized microRNA-132-3p levels from baseline to week 24, while secondary outcomes include measures of heart volume and biomarkers, plus adverse event counts.

This research aims to evaluate how CDR132L, a potential new medicine, affects the structure and function of the heart in people living with heart failure who have preserved ejection fraction and left ventricular hypertrophy. The study compares different doses of CDR132L to a placebo, with treatment assignment determined randomly. It is a phase 2, multicenter, randomized, double-blind, placebo-controlled trial sponsored by Novo Nordisk AS, lasting about 60 weeks. Participants will receive intravenous infusions of one of three doses of CDR132L or placebo once every 4 weeks for 48 weeks. Alongside the study drug or placebo, participants will continue their individually adapted guideline-directed standard of care therapy for heart failure. This treatment period is followed by an extension phase to monitor safety and efficacy. During the study, participants will undergo assessments including measuring the change in normalized microRNA-132-3p levels from baseline to week 24, as well as cardiac magnetic resonance imaging to evaluate heart structure changes and blood tests like NT-proBNP levels. Safety is monitored by recording adverse events up to week 60. The total participation duration is approximately 60 weeks, involving regular infusions and follow-up visits.

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.

Researchers are evaluating efruxifermin EFX in a phase 3, randomized, double-blind, placebo-controlled study involving adults with compensated cirrhosis caused by NASH Nonalcoholic Steatohepatitis or MASH Metabolic Dysfunction-Associated Steatohepatitis. This study aims to assess the safety and effectiveness of EFX in preventing significant clinical events such as disease progression and liver decompensation over a period of up to 5 years. Participants are randomly assigned to receive either efruxifermin 50 mg or a placebo, both given by subcutaneous injection. The study includes two cohorts one with biopsy-proven compensated cirrhosis and specific metabolic scores, and another with biopsy-proven or non-invasive diagnosis of compensated cirrhosis. The study treatment and monitoring extend up to 5 years, with evaluations at 96 weeks and long-term follow-up to track liver fibrosis, markers of liver injury, insulin sensitivity, glycemic control, body weight, and safety outcomes. During the trial, participants undergo regular assessments including laboratory tests, ECGs, ultrasounds, and vital sign monitoring. Researchers will measure changes in liver fibrosis, steatohepatitis resolution, and metabolic markers throughout the study. Safety and tolerability are closely tracked by documenting adverse events and exposure duration. The study duration allows for long-term observation of treatment effects and disease progression, with participant involvement lasting up to 5 years.

Researchers are evaluating efruxifermin EFX in adults with non-cirrhotic nonalcoholic steatohepatitis NASH or metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage 2 or 3. This Phase 3, multi-center, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of EFX compared with placebo. The trial includes about 1,650 participants divided into two cohorts based on liver biopsy characteristics and fibrosis stage. Participants will be randomly assigned to one of three groups EFX 28 mg, EFX 50 mg, or placebo, each given as a weekly subcutaneous injection. Cohort 1 will be evaluated over 52 weeks for histologic efficacy endpoints, while Cohort 2 will have assessments over 96 weeks. After these periods, participants may continue long-term treatment and clinical follow-up for up to approximately 240 weeks total. A follow-up visit will occur about 30 days after the last dose. During the study, participants will undergo liver biopsies, blood tests, and non-invasive assessments such as FibroScan and Enhanced Liver Fibrosis ELF score to monitor liver health and fibrosis. Researchers will track liver-related clinical outcomes, including liver events and survival, as well as safety and tolerability of the treatment. Participants who stop the study drug may still continue with scheduled assessments to support long-term safety and efficacy evaluations.

This trial is for adults with recurrent or metastatic head and neck squamous cell carcinoma HNSCC that has not been treated with systemic therapy before. The study compares the anti-tumor effects of amivantamab combined with pembrolizumab and carboplatin against pembrolizumab with 5-fluorouracil and platinum therapy carboplatin or cisplatin. Participants have HNSCC in the oral cavity, oropharynx, hypopharynx, or larynx but not nasopharynx or unknown primary tumor sites, and HPV status is considered for oropharynx cases. Participants are randomly assigned to one of two groups. One group receives pembrolizumab, amivantamab, and carboplatin, while the other receives pembrolizumab, 5-fluorouracil given as a 4-day infusion, and carboplatin or cisplatin. Treatments are given according to standard protocols for these drugs. The study is open-label and conducted across multiple centers. During the trial, participants will be monitored for overall survival and tumor response using established criteria up to about 3 years and 7 months. Additional assessments include progression-free survival, duration of response, quality of life questionnaires specific to head and neck cancer, and safety evaluations through adverse event and lab test monitoring. Blood samples will check amivantamab levels and antibodies. Participation involves regular visits for treatment and assessments throughout the study period.

Researchers are evaluating the efficacy and safety of eloralintide in adults with moderate-to-severe obstructive sleep apnea who are also overweight or obese. This trial is structured as a master protocol called YDAO, which supports two studies YSA1 for participants who do not use or refuse Positive Airway Pressure PAP therapy, and YSA2 for those who have been on PAP therapy for at least three months and plan to continue it. The study aims to understand how eloralintide affects body weight and sleep apnea severity over time. Participants will be randomly assigned to receive either eloralintide or a placebo through subcutaneous injections once weekly. The study includes two parallel groups reflecting current PAP therapy use. Treatment lasts about 64 weeks, followed by assessments. The design includes double-blinding to compare the effects between intervention and placebo groups. During the study, participants will be closely monitored for changes in body weight and apnea-hypopnea index AHI at baseline and week 64. Additional measurements include blood pressure, triglycerides, inflammation markers, sleep-related impairment scores, and glucose metabolism. Researchers will also track patient-reported outcomes, medication use, and pharmacokinetics. Participation lasts approximately 76 weeks, covering screening, treatment, and follow-up evaluations to ensure safety and collect comprehensive data.