Taringa

Researchers are studying a medicine called enlicitide to reduce low-density lipoprotein cholesterol (LDL-C) in adults with high cholesterol (hyperlipidemia). This trial aims to find out if taking enlicitide together with rosuvastatin, a standard cholesterol-lowering drug, works better than a placebo in lowering LDL-C levels. The study is a Phase 3 trial that is randomized, double-blind, and placebo-controlled to ensure accurate and unbiased results. Participants will receive oral tablets of enlicitide or placebo along with oral capsules of rosuvastatin or placebo. The study compares the effect of enlicitide plus rosuvastatin against placebo to evaluate their impact on LDL-C. The treatment period lasts 8 weeks, during which participants take their assigned medications as directed. During the study, researchers will measure the average percent change in LDL-C from the start of the trial to week 8. Participants will be monitored for safety and any side effects throughout the study. The total participation time includes screening, treatment, and follow-up assessments to evaluate the medicines' effects and safety in adults aged 18 to 64 with hyperlipidemia.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.

Researchers are conducting a multicenter, prospective, randomized, double-blind, placebo-controlled Phase 3 study to assess the effectiveness, safety, and tolerability of a single intra-articular injection of PTP-001 (MOTYS) in adults aged 40 to 80 years with knee osteoarthritis. The study focuses on participants with mild to moderate radiographic knee OA and symptomatic knee pain, aiming to compare PTP-001 against a placebo over a 52-week period. Participants will be randomly assigned in equal numbers to receive either a single dose of PTP-001 or a placebo saline injection into the target knee on Day 1. The study includes a screening period up to 28 days before treatment, a one-day treatment phase, and a 12-month follow-up phase. A total of at least 260 participants are planned, with 130 in each treatment group. During the study, participants will undergo evaluations to measure improvements in knee function and pain at 6 months. Researchers will monitor symptoms using pain scales and collect safety data throughout the year. Participants are expected to adhere to study visit schedules, use acetaminophen as needed for knee pain, and avoid other unauthorized medications during the trial.

Researchers are evaluating the safety and immune response of various vaccine formulations targeting the Respiratory Syncytial Virus (RSV) monovalent antigen and the Influenza A H5 hemagglutinin antigen in healthy adults aged 18 to 49 years. This Phase 1 study aims to understand how these vaccines perform in stimulating the immune system and their safety profiles in this age group. Participants receive one of several investigational vaccine formulations administered by intramuscular injection. The study includes multiple arms with different vaccine types, each lasting about 6 to 7 months depending on the assigned group. Vaccines containing the Flu H5 antigen and RSV antigen are given and monitored separately, with follow-up phases to assess ongoing safety and immune response over time. Throughout the study, participants are closely monitored for any adverse events, including those occurring immediately after vaccination and during the following days and months. Researchers measure immune responses such as antibody levels before vaccination and at several points afterward. Safety assessments include tracking serious adverse events, special interest events, and any events leading to discontinuation, with blood tests and participant diaries supporting data collection. The total participation time varies by treatment arm but generally spans several months to ensure thorough observation.