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New hope for chagas: experimental drug aims to wipe out parasites

NCT ID NCT06632600

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 7 times

Summary

This study tests an experimental drug called LXE408 in 130 adults with chronic Chagas disease who do not have severe organ damage. The goal is to see if LXE408 can clear or reduce the parasite level in the blood over 6 months, compared to placebo and standard treatment. Participants take the drug by mouth for 28 days, and researchers check for parasites using a sensitive test (PCR) at several time points.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LXE408 (an experimental oral drug)
What this could lead to
If successful, this could provide a new treatment option for chronic Chagas disease, potentially reducing parasite levels and preventing disease progression.
What could go wrong
This is an early Phase 2 trial with only 130 participants, so results may not apply to everyone. The drug may not clear parasites as hoped, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Chagas disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chagas disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030-3411, United States

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Novartis Investigative Site

    RECRUITING

    CABA, Buenos Aires, C1221ADC, Argentina

  • Novartis Investigative Site

    RECRUITING

    CABA, Buenos Aires, C1407FWE, Argentina

  • Novartis Investigative Site

    RECRUITING

    Córdoba, Córdoba Province, X5016KEH, Argentina

  • Novartis Investigative Site

    RECRUITING

    Caba, C1015ABO, Argentina

  • Novartis Investigative Site

    RECRUITING

    Corrientes, W3400CDS, Argentina

  • Novartis Investigative Site

    RECRUITING

    Formosa, P3600KGC, Argentina

  • Novartis Investigative Site

    RECRUITING

    Montes Claros, Minas Gerais, 39401-001, Brazil

  • Novartis Investigative Site

    RECRUITING

    Recife, Pernambuco, 50100-060, Brazil

  • Novartis Investigative Site

    RECRUITING

    Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil

  • Novartis Investigative Site

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90601-000, Brazil

  • Novartis Investigative Site

    RECRUITING

    São Caetano do Sul, São Paulo, 09521-160, Brazil

  • Novartis Investigative Site

    RECRUITING

    São Paulo, São Paulo, 01232-010, Brazil

  • Novartis Investigative Site

    RECRUITING

    Barranquilla, Atlántico, 080005, Colombia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Yopal, Casanare Department, 850009, Colombia

  • Novartis Investigative Site

    RECRUITING

    Bogotá, 110131, Colombia

  • Novartis Investigative Site

    RECRUITING

    Bogotá, 111411, Colombia

  • Novartis Investigative Site

    RECRUITING

    Floridablanca, 681017, Colombia

  • Novartis Investigative Site

    RECRUITING

    San Gil, 684031, Colombia

  • Olive View UCLA Educ and Res Ins

    RECRUITING

    Sylmar, California, 91342, United States

  • University of Florida Shands

    RECRUITING

    Gainesville, Florida, 32610-0486, United States

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