Phase 2 Study to Evaluate the Safety and Effectiveness of Oral LXE408 Compared to Placebo and Benznidazole in Adults With Chronic Chagas Disease Without Severe Organ Damage

What this Trial Is About

Researchers are evaluating LXE408 in adults with chronic Chagas disease without severe organ dysfunction. This study is a phase 2, randomized, participant- and investigator-blinded, controlled trial with four treatment groups. The goal is to assess the effectiveness, safety, tolerability, pharmacokinetics, and pharmacodynamics of LXE408 compared to placebo and benznidazole in clearing or reducing parasites in the blood. Participants are randomly assigned to one of four 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. The study monitors parasite clearance using PCR tests at multiple time points, including early clearance at days 7, 14, and 28, and sustained clearance for up to 12 months. Pharmacokinetic measurements of LXE408 are also taken during treatment. Participants will undergo regular assessments including PCR testing for parasite levels at months 2, 4, 6, and 12, serology tests at months 6 and 12, and monitoring for adverse events up to 48 months. Safety evaluations and pharmacokinetic blood samples are collected during treatment. The total study duration extends up to 6 years including long-term follow-up to track treatment impact and participant health.

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