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Testing LXE408 for treating 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.

Phase 2 Interventional Novartis · NCT06632600

This study is testing a new drug called LXE408 to see if it can effectively treat chronic Chagas disease in people who don't have severe organ problems.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment130 (estimated)
Ages18 Years to 60 Years
SexAll
SponsorNovartis Industry-sponsored
Locations19 sites (Sylmar, California and 18 other locations)
Trial IDNCT06632600 on ClinicalTrials.gov

What this trial studies

This interventional phase 2 study investigates the efficacy, safety, and tolerability of LXE408 in participants with chronic Chagas disease who do not have severe organ dysfunction. The study is designed as a randomized, participant- and investigator-blinded, controlled trial with four treatment arms, comparing LXE408 to a placebo and benznidazole. The primary goal is to assess the anti-parasitological activity of LXE408 and its pharmacokinetics and pharmacodynamics in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 with a confirmed diagnosis of chronic Chagas disease without severe organ dysfunction.

Not a fit: Patients with signs of acute Chagas disease or those who have previously been treated with benznidazole or nifurtimox may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce or eliminate the level of parasites in the blood of patients with chronic Chagas disease.

How similar studies have performed: While there have been studies on treatments for Chagas disease, the specific approach using LXE408 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male or female participants aged ≥ 18 years to ≤ 60 years old
* Confirmed diagnosis of T. cruzi infection
* History that participant has been determined to be in chronic phase of CD
* Written informed consent must be obtained before any assessment is performed, and participants should express understanding of the consent form and the study
* Participants must be considered by the investigator eligible for and able to comply with local prescribing information for benznidazole
* Ability and willingness to communicate well with the investigator/study site and comply with requirements of the study

Exclusion Criteria:

* Signs (on physical examination) and/or symptoms of CD in the acute phase as determined by the investigator at screening
* History of CD treatment with benznidazole or nifurtimox at any time in the past
* History of and/or current (at screening) symptoms or signs (physical examination findings) of moderate or severe CD-related gastrointestinal disease
* Participants who weigh \< 50 kg or \>90kg at screening
* At sites conducting the MRI assessments, participants may participate in the overall study, but will be excluded from the MRI assessment if they have contraindications to MRI imaging
* Any clinically significant disease during screening that, in the opinion of the investigator, would put the safety of the participant at risk through participating, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study, or would compromise participant compliance or preclude completion of the study
* Documented history or current findings at screening of clinically significant cardiovascular conditions such as, but not limited to: unstable ischemic heart disease; NYHA Class III/IV heart failure (due to Chagas disease or other conditions); arrhythmias
* Known or suspected ongoing, chronic or recurrent viral, bacterial or fungal infectious diseases including but not limited to: Tuberculosis, leishmaniasis, severe malaria, atypical mycobacterial infection, listeriosis, aspergillosis, or endemic mycoses, and/or documented positivity for human immunodeficiency virus (HIV) infection.

  * Participants with controlled HIV on antiretroviral therapy are eligible to participate if CD4 ≥ 500 at screening
* History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years prior to screening (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed)
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant during the study period

  * Pancreatic injury or pancreatitis: If any single parameter of amylase or lipase exceeds 1.5x ULN at screening Participants with known recurrent pancreatitis (more than 1 episode in lifetime, from any cause) are excluded
  * Liver disease or liver injury as indicated by abnormal liver function tests (LFTs):

Any single parameter of ALT, AST, alkaline phosphatase must not exceed 1.5x ULN at screening Serum bilirubin must not exceed the ULN at screening elevated serum bilirubin is not excluded if there is a documented history of Gilbert's Syndrome

* History of renal disease as indicated by creatinine level above 1.5x ULN or microalbuminuria at screening; Evidence of urinary obstruction, or difficulty in voiding at screening; evidence of congenital renal abnormalities with known effect on renal function; calculated eGFR \<60 mL/min (\<0.835 mL/s) using the CKD-EPI formula for adults

  * Participants with screening hematology parameters outside of the thresholds
  * Current use of medications prohibited by the protocol at screening and/or baseline visits, or expected use of any prohibited medication during the study treatment period
* Use of benznidazole in the blinded arms is prohibited until unblinding occurs after all participants complete Month 12.

  * Use of other investigational drugs at the time of study drug dosing
  * History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study or to benznidazole
  * History of drug abuse or unhealthy alcohol use within the 12 months prior to dosing
  * Pregnant or nursing (lactating/breast-feeding) women
  * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 5 days after stopping of investigational drug and benznidazole
  * Participants who, in the opinion of the investigator, will not be able to comply with study procedures or visits, adhere to dosing schedule, or other otherwise be in compliance with study requirements

Other protocol-defined inclusion/exclusion criteria may apply.

Where this trial is running

Sylmar, California and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chagas DiseaseLXE408Chronic Chagas diseaseChronic indeterminate Chagas diseaseChronic Chagas disease without severe organ dysfunctionCICDChronic CDTrypanosoma cruzi
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.