A Randomized, Blinded, Controlled Study to Assess the Efficacy, Safety, and Pharmacology of LXE408 Compared to Placebo and Benznidazole in Adults With Chronic Chagas Disease Without Severe Organ Dysfunction

What this Trial Is About

Researchers are evaluating the ability of LXE408 to reduce or clear parasites in the blood of people living with chronic Chagas disease who do not have severe organ dysfunction. This phase 2, randomized, participant- and investigator-blinded study aims to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of LXE408 compared to placebo and benznidazole. The study focuses on adults with chronic indeterminate Chagas disease without severe cardiac or gastrointestinal symptoms. Participants will be assigned to one of four treatment groups: LXE408 taken orally for 28 days, LXE408 for 14 days followed by placebo for 14 days, placebo for 28 days, or benznidazole for 60 days. This parallel group design allows comparison of LXE408 at different durations against placebo and an active standard-of-care drug. Treatments are all given by mouth, and the study includes a control arm to evaluate safety and tolerability alongside efficacy. During the study, participants will have blood tested by polymerase chain reaction (PCR) at months 2, 4, 6, and 12 to measure parasite levels and confirm clearance. Additional assessments include serology tests, pharmacokinetic blood sampling at multiple time points, and monitoring of adverse events throughout up to 48 months. Researchers will track time to parasite clearance and any treatment side effects while ensuring participants can comply with study visits and follow-up requirements.

A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.