Rishikesh

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating the safety and immune response of BBV87, an inactivated Chikungunya virus vaccine, in healthy individuals aged 12 to 65 years. This seamless Phase II/III clinical trial aims to study the vaccine's immunogenicity, safety, and consistency across different production lots. The study involves approximately 1000 participants randomized regardless of their prior exposure to Chikungunya virus. Participants will be randomly assigned in a 3:3:3:1 ratio to receive one of three lots of the BBV87 vaccine or a placebo. Each participant will receive two doses of the vaccine or placebo, with each vaccine dose containing 40 micrograms of the inactivated virus. The study is observer-blind, and safety data will be reviewed by an independent board after Day 56 to ensure participant protection. During the study, participants will undergo assessments to measure antibody levels 28 days after the second vaccine dose. Researchers will monitor immune responses, including the percentage of participants who develop antibodies and the consistency of antibody levels across vaccine lots. Safety evaluations will be ongoing throughout the trial to assess any adverse effects or concerns related to the vaccine. The total participation period includes vaccination and follow-up visits up to Day 56.

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.

This research aims to assess the effectiveness and safety of eloralintide in adults with moderate to severe obstructive sleep apnea who are also obese or overweight. The study is organized under a master protocol called YDAO, which supports two separate studies: YSA1 for participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy, and YSA2 for those who have been using PAP therapy for at least three months and intend to continue it during the study. This is a Phase 3 randomized, double-blind, placebo-controlled trial focused on this specific population. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once weekly. They will be assigned to one of two groups based on their current PAP therapy use: those not using PAP (YSA1) and those continuing PAP (YSA2). The study treatment and observation will last about 76 weeks, allowing detailed evaluation over time. During the study, participants will undergo assessments including polysomnography to measure the apnea-hypopnea index (AHI) and body weight changes from baseline to week 64. Researchers will monitor weight, sleep apnea severity, and safety throughout the trial. The long participation period includes screening, treatment, and follow-up to capture comprehensive data on eloralintide’s effects and tolerability.

Researchers are studying how well and safely orforglipron works in adult women who have stress urinary incontinence (SUI) and are overweight or have obesity. SUI is a condition where urine leaks during movements like coughing or exercising. This trial is part of a master protocol including two independent studies, and it is a Phase 3 clinical trial. Participants will be randomly assigned to receive either orforglipron tablets or a placebo, both taken orally once daily. The treatment period and study participation will last approximately 58 weeks, including screening and safety follow-up. The study compares the effects of orforglipron against placebo in this specific group of female patients. During the study, researchers will track changes in the frequency of incontinence episodes from the start to week 52. Participants will undergo screening, treatment, and safety monitoring throughout the trial. The study aims to assess the effectiveness and safety of orforglipron in reducing urinary leakage events over time.

Researchers are evaluating the safety and effectiveness of orforglipron taken once daily in adults with Fontaine Stage II peripheral arterial disease (PAD), a condition causing pain and difficulty walking due to narrowed arteries. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand how orforglipron affects walking ability and overall safety in people with this condition. Participants will be involved in the study for about 58 weeks. Participants will receive either orforglipron or a placebo, both administered orally once daily. The study includes a comparison between these two groups to assess the impact of orforglipron on walking distance and other health outcomes over the course of the trial. During the study, researchers will measure changes in the maximum distance participants can walk compared to their baseline, particularly at the start and after 52 weeks of treatment. Participants will be monitored for safety and any side effects throughout the study. The total duration of participation is approximately 58 weeks, allowing for thorough evaluation of the treatment's effects and safety.

Researchers are evaluating the effects of pre-operative chlorhexidine mouthwash and perioperative oxygen levels on the rates of pneumonia and surgical site infections in patients undergoing major abdominal surgery. This Phase 3, multi-center, randomized controlled trial is conducted across hospitals in low and middle-income countries, focusing on adults and children aged 10 years or older having elective or emergency midline laparotomy. The study aims to reduce serious postoperative complications that significantly contribute to mortality and healthcare burden, especially in these resource-limited settings. Participants will be randomly assigned to one of four groups combining the use or non-use of chlorhexidine mouthwash before surgery and different oxygen concentrations during surgery: (a) mouthwash with high oxygen (80-100% FiO2), (b) no mouthwash with high oxygen, (c) mouthwash with low oxygen (21-30% FiO2), or (d) no mouthwash with low oxygen. The trial includes a 6-month internal pilot phase to assess recruitment and compliance, followed by a main phase enrolling approximately 12,924 participants. During the study, researchers will monitor participants for pneumonia and surgical site infections within 30 days after surgery using CDC definitions. Data on treatment adherence and participant outcomes will be collected and assessed by blinded outcome assessors. The study will track complications and follow patients through their recovery to evaluate how these interventions might reduce postoperative infections and improve surgical outcomes.

Researchers are evaluating the safety, pharmacokinetics, and pharmacodynamics of oral AUR112 in patients with relapsed advanced lymphomas. This Phase 1, open-label, dose escalation study aims to assess the tolerability of AUR112 and determine the doses suitable for future trials. The study involves patients with relapsed Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Hodgkin disease who have exhausted other effective therapies locally. Participants will receive AUR112 once daily, with dose escalation following a classic 3+3 design. Dose escalation continues until safety limits are reached or pharmacokinetic and pharmacodynamic data indicate a biologically active dose. The study monitors dose limiting toxicities and treatment-related adverse events, alongside detailed pharmacokinetic measurements at specified time points. During the study, participants will be closely monitored through clinical assessments and laboratory tests to evaluate safety and drug behavior in the body. Key outcomes include dose limiting toxicities within the first treatment cycle, adverse events graded by standard criteria, and pharmacokinetic parameters such as maximum concentration and half-life. The study also evaluates safety under fasting and fed conditions over a 28-day treatment cycle.

Researchers are investigating oral squamous cell carcinoma, particularly cases with advanced nodal disease (N2-N3), to determine the benefit of adding induction chemotherapy before surgery. This phase 3, multicenter, randomized controlled trial focuses on patients with operable oral cancer presenting at an advanced stage, aiming to improve disease-free survival and overall outcomes by better selecting patients likely to respond to treatment. The study addresses limitations of earlier trials that included heterogeneous patient groups and stages, which may have affected results. Participants are randomly assigned to one of two treatment groups: the standard arm receives surgery followed by adjuvant radiotherapy with or without concurrent chemotherapy, while the experimental arm receives two cycles of TPF or TPX induction chemotherapy before surgery, then the same adjuvant treatment. The chemotherapy regimens include docetaxel, cisplatin, and 5-fluorouracil or capecitabine, administered in specific dosing schedules over a three-week cycle. Patients showing disease progression but still resectable may proceed to surgery, while others may receive alternative treatments. During the study, participants will be monitored for disease-free survival over two years, with further follow-up extending to five years. Researchers will also evaluate overall survival, treatment response rates, toxicity, compliance, postoperative complications, and quality of life. Tissue samples from oral cancer will be collected for future research. The study aims to enroll 346 patients aged 18 to 75 with adequate organ function and performance status, assessing the impact of induction chemotherapy on long-term outcomes.