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

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, andparticipants should express understanding of the consent form and the study

• Participants must be considered by the investigator eligible for and able to complywith local prescribing information for benznidazole

• Ability and willingness to communicate well with the investigator/study site andcomply with requirements of the study

Exclusion Criteria:

• Signs (on physical examination) and/or symptoms of CD in the acute phase asdetermined 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 examinationfindings) 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 overallstudy, but will be excluded from the MRI assessment if they have contraindicationsto MRI imaging

• Any clinically significant disease during screening that, in the opinion of theinvestigator, would put the safety of the participant at risk through participating,or which would affect the efficacy or safety analysis if the disease/conditionexacerbated during the study, or would compromise participant compliance or precludecompletion of the study

• Documented history or current findings at screening of clinically significantcardiovascular conditions such as, but not limited to: unstable ischemic heartdisease; NYHA Class III/IV heart failure (due to Chagas disease or otherconditions); arrhythmias

• Known or suspected ongoing, chronic or recurrent viral, bacterial or fungalinfectious diseases including but not limited to: Tuberculosis, leishmaniasis,severe malaria, atypical mycobacterial infection, listeriosis, aspergillosis, orendemic mycoses, and/or documented positivity for human immunodeficiency virus (HIV)infection

• History of lymphoproliferative disease or any known malignancy or history ofmalignancy of any organ system within the past 5 years prior to screening (exceptfor basal cell carcinoma or actinic keratosis that have been treated with noevidence of recurrence in the past 3 months, carcinoma in situ of the cervix ornon-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 theparticipant during the study period

• Pancreatic injury or pancreatitis: If any single parameter of amylase or lipaseexceeds 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, GGT, 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 or hematuria 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 baselinevisits, or expected use of any prohibited medication during the study treatmentperiod

• Use of other investigational drugs at the time of study drug dosing

• History of multiple and recurring allergies or allergy to the investigationalcompound/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 ofbecoming pregnant, unless they are using highly effective methods of contraceptionduring 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 complywith study procedures or visits, adhere to dosing schedule, or other otherwise be incompliance with study requirements

Other protocol-defined inclusion/exclusion criteria may apply.