NCT06632600 · Novartis Pharmaceuticals
A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.
What this study is about
This study is to investigate the ability of LXE408 to reduce or remove the level of parasites in the blood of people with chronic Chagas disease. Participants must have chronic Chagas disease without severe organ dysfunction.
View original scientific description
This study is to investigate the ability of LXE408 to reduce or remove the level of parasites in the blood of people with chronic Chagas disease. Participants must have chronic Chagas disease without severe organ dysfunction.
Interventions
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)
Primary outcome measures
Presence or absence of sustained parasitological clearance using polymerase chain reaction (PCR) results over 6 months - LXE408 28 days versus placebo.
Time frame: At Months 2, 4, and 6
The parasitological load will be measured using polymerase chain reaction (PCR) at 2 months, 4 months, and at 6 months. At each timepoint, multiple samples are evaluated. The participant will be considered negative at a visit if the parasite is not detectable in all samples at a visit and positive if the parasite level is detectable in at least one sample. Sustained parasitological clearance is achieved if participant is negative at all 3 visits.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether 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
Where
- Sylmar, California
- Gainesville, Florida
- Boston, Massachusetts
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 1, 2026 · Source of record for eligibility and locations