A Phase 2 interventional study of EYU688 and Placebo in Dengue, sponsored by Novartis Pharmaceuticals. Recruiting at 27 sites in 7 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
The purpose of this study is to characterize the effect on dengue viral load, fever clearance time as well as on clinical signs and symptoms with the treatment of EYU688 compared with placebo in patients with dengue fever.
This is a randomized, participant- and investigator- blinded, placebo-controlled study to investigate the efficacy and safety of EYU688 administered orally in patients with dengue fever.
Due to the different PK sampling schedules applied, the study consists of two cohorts run in parallel (intensive PK [cohort 1] and sparse PK sampling [cohort 2]).
283 studies on the registry are indexed under Dengue; 44 are open to participants now.
This study's planned enrollment of 108 is below the median of 132 across 197 interventional studies indexed under Dengue.
Browse Dengue studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants with any of the following abnormalities of clinical laboratory parameters at screening:
History or long- syndrome, or abnormalities, or any of the following ECG abnormalities at screening:
Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EYU688 administered by oral route
Drug: EYU688
Matching placebo
Drug: Placebo
EYU688 administered by oral route
Matching placebo administered orally as capsules
Viremia reduction (viral load reduction (VLR) on log scale) at 48 hours post treatment start
Efficacy assessment of EYU688. It will allow to quantify the viremia reduction at 48 hours post treatment start from baseline.
Time frame: From predose to 48 hours post treatment start
Time from fever onset to start of the first 48 hours period during which the oral temperature remained below 37.5℃
Efficacy assessment of EYU688. It will allow to assess the time needed between fever onset and defervescence.
Time frame: From fever onset to Day 15
Time from fever onset to the first of two consecutive negative viremia by PCR
Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day15
Time frame: From fever onset to Day 15
Area under the log-transformed viremia curve (AUC) from the first dose to Day 15
Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day 15
Time frame: From fever onset to Day 15
Changes of viral load over time
Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day15
Time frame: From baseline to Day 15
Incidence and severity of Adverse Events (AEs)
Incidence and severity of AEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
Time frame: From inclusion to Day 15
Incidence and severity of Serious Adverse Events (SAEs)
Incidence and severity of SAEs by treatment group
Time frame: From inclusion to Day 35
Change of white blood cell count over time from baseline
Assessment of safety and tolerability of EYU688
Time frame: From baseline to Day 15
Change of platelet count over time
Assessment of safety and tolerability of EYU688
Time frame: From baseline to Day 15
Change of hematocrit level and percentage increase from baseline over time
Assessment of safety and tolerability of EYU688
Time frame: From baseline to Day 15
Change of AST, ALT levels over time
Assessment of safety and tolerability of EYU688
Time frame: From baseline to Day 15
No warning signs by day 7 of fever onset
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From inclusion to Day 15
Diagnosis of severe dengue fever
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From inclusion to Day 15
Diagnosis of dengue hemorrhagic fever (DHF)
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From inclusion to Day 15
Plasma leakage
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From inclusion to Day 15
Requiring fluid infusion
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From inclusion to Day 15
Time from fever onset to clinical recovery
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From fever onset to Day 15
PK parameter (Cmax)
Pharmacokinetic assessment of EYU688 in dengue fever patients
Time frame: From Day 1 to Day 6
PK parameter (Tmax)
Pharmacokinetic assessment of EYU688 in dengue fever patients
Time frame: From Day 1 to Day 6
PK parameter (partial AUCs)
Pharmacokinetic assessment of EYU688 in dengue fever patients
Time frame: From Day 1 to Day 6
PK concentrations following multiple doses
Pharmacokinetic assessment of EYU688 in dengue fever patients
Time frame: From Day 1 to Day 6
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Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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