NCT06632600

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

A Randomized, Participant- and Investigator-blinded, Controlled, Parallel Group Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LXE408 in Participants With Chronic Chagas Disease Without Severe Organ Dysfunction.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is to investigate the ability of LXE408 to clear or reduce the level of parasites in the blood of people with chronic Chagas disease. Participants must have chronic Chagas disease without severe organ dysfunction.

Detailed description

This is an interventional, phase 2, PoC (Proof of Concept) randomized, participant- and investigator-blinded, controlled, parallel group study, with 4 treatment arms. The purpose of this study is to assess the efficacy (anti-parasitological activity), safety, PK (pharmacokinetics), and PD (pharmacodynamics) of LXE408 in participants with CICD (chronic indeterminate Chagas disease) and chronic Chagas disease without severe cardiac or gastrointestinal dysfunction compared to placebo and to benznidazole.

Conditions

• Chagas Disease

Interventions

Type	Name	Description
DRUG	LXE408	LXE408 administered by oral route
DRUG	Placebo	Placebo administered by oral route
DRUG	Benznidazole	Benznidazole administered by oral route (administered as standard of care)

Timeline

• Start date: 2025-04-28
• Primary completion: 2027-03-22
• Completion: 2030-09-21
• First posted: 2024-10-09
• Last updated: 2026-03-30

Locations

19 sites across 4 countries: United States, Argentina, Brazil, Colombia

Regulatory

• FDA-regulated drug study