San Gil

Researchers are evaluating the ability of the drug LXE408 to clear or reduce parasites in the blood of people with chronic Chagas disease who do not have severe organ dysfunction. This phase 2, proof-of-concept, randomized, participant- and investigator-blinded study compares LXE408 to placebo and the standard treatment benznidazole. The study aims to assess the effectiveness, safety, how the drug moves through and affects the body, and tolerability of LXE408 in adults with chronic indeterminate Chagas disease. The study includes four treatment groups with LXE408, placebo, and benznidazole administered orally. Participants receive the assigned treatments according to the study protocol. The study design is parallel group controlled, ensuring participants receive only their assigned treatment. Specific dosing details and treatment duration are outlined in the study plan. Participants will be monitored through visits that include blood tests using polymerase chain reaction (PCR) to check for parasite clearance at 2, 4, and 6 months after treatment starts. Safety and efficacy will be evaluated through clinical assessments, laboratory tests, and participant questionnaires. The study tracks how well participants adhere to the treatment and monitors for any side effects, with follow-up lasting at least six months to observe sustained parasite clearance.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.