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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 2

Age range

18 years - 60 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

130 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Quadruple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (22)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

22 locations

Study team and timeline

Lead sponsor

Novartis Pharmaceuticals

Study start

Apr 28, 2025 Actual

Primary completion

Jul 22, 2027 Estimated

Study completion

Jan 21, 2031 Estimated

First posted

Oct 9, 2024 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts