Vega Baja

Researchers are studying the effectiveness and safety of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 trial aims to understand how eloralintide affects body weight and related health measures over a long period. The study includes a main phase and an extension phase for those with prediabetes to evaluate ongoing effects. Participants are randomly assigned to receive one of four doses of eloralintide or a placebo, all given by subcutaneous injection once weekly. The main phase lasts about 75 weeks, and participants with prediabetes may continue in an extension phase for an additional two years. This structure allows researchers to assess both short-term and longer-term outcomes. During the study, participants will have regular visits to measure body weight, body fat, waist size, blood pressure, blood markers like triglycerides and insulin, and quality of life questionnaires. Safety and treatment effects are monitored throughout. The main outcome is the percent change in body weight from the start to week 64, with follow-up continuing up to week 191 for some. Overall participation can last up to several years depending on the participants health status.

Researchers are evaluating the safety, immune response, and effectiveness of the V181 dengue vaccine in healthy children aged 2 to 17 years. This study aims to see if V181 can reduce the number of dengue infections caused by any of the four dengue virus types, regardless of whether participants have had dengue before. The trial is a phase 3, randomized, double-blind, placebo-controlled study sponsored by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive a single 0.5 mL dose of either the V181 vaccine or a placebo by subcutaneous injection on Day 1. About 3600 participants are included in the Reactogenicity and Immunogenicity Subset, which will be monitored for safety and immune response for 28 days after vaccination. A smaller group of about 620 participants from this subset will be followed for up to 5 years to assess long-term immune response using specific virus neutralization tests. During the study, participants will be monitored for adverse events, vaccine reactions, and dengue infections, including severity and hospitalization rates, up to 5 years after vaccination. Safety assessments include tracking medically attended and serious adverse events. Immune responses will be measured by antibody levels and seroconversion rates. Participants will have scheduled visits during the first month postvaccination and ongoing follow-ups for several years to evaluate the vaccines long-term effects and protective benefits.

Researchers are investigating the efficacy and safety of duvakitug in people with moderately to severely active Crohns Disease in a multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. The trial includes three sub-studies aiming to evaluate duvakitugs effects compared to placebo during induction treatment phases, focusing on clinical remission and endoscopic response at 12 weeks. Participants receive subcutaneous injections of duvakitug or placebo following the study protocol. The study duration can be up to 35 weeks, including a screening period of up to 5 weeks, followed by a 12-week induction phase in either Sub-Study 1 open-label, Sub-Study 2 pivotal induction, or Sub-Study 3 extended induction for non-responders. A 6-week follow-up period applies to participants not entering the maintenance study. Throughout the trial, participants undergo scheduled visits for assessments including clinical remission based on Crohns Disease Activity Index and endoscopic scores. Safety is monitored with reports of adverse events and serum drug levels. Up to 8 to 15 visits are planned depending on the sub-study, with follow-up continuing for 45 days after the last dose for those not moving to maintenance treatment.

Researchers are evaluating the efficacy and safety of duvakitug, a drug given by subcutaneous injection, in people with moderately to severely active Ulcerative Colitis UC. This Phase 3 randomized, double-blind, placebo-controlled study includes participants aged 16 to 80 years and aims to assess clinical remission and other health improvements over a series of treatment periods. The study lasts up to 35 weeks and includes a screening period followed by three possible sub-studies a 12-week open-label induction, a 12-week pivotal induction, and a 12-week extended induction for those who do not respond initially. Participants receive injections of either duvakitug at one of two doses or placebo according to the study protocol, with up to 15 visits scheduled for those in extended induction. During the study, participants will undergo assessments including clinical remission rates at week 12, endoscopic and histological improvements, symptom tracking, quality of life questionnaires, and safety monitoring for adverse events. Follow-up visits occur up to 45 days after the last dose for those not continuing in the maintenance study. Researchers will also measure drug levels and immune responses over the study period to better understand treatment effects.