A Phase 1 interventional study of ALG-097558 in COVID-19, sponsored by Aligos Therapeutics. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Aligos Therapeutics · Phase 1, Interventional, and Treatment
This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic impairment, matched for age, body weight and, to the extent possible, for gender. The primary purpose of this study is to characterize the effect of hepatic impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily (Q12H) oral (PO) doses.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 16 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Aligos Therapeutics is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) 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.
4. Female subjects must have a negative serum pregnancy test at screening
Inclusion Criteria for Subjects with Normal Hepatic Function:
Inclusion Criteria for Subjects with Impaired Hepatic Function:
Exclusion Criteria for All Subjects:
Exclusion Criteria for Subjects with Normal Hepatic Function:
Exclusion Criteria for Subjects with Impaired Hepatic Function:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
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.
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 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).
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
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.
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.
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.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
Drug: ALG-097558
Demographically matched subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
Drug: ALG-097558
Multiple doses of ALG-097558 200 mg (2 x 100 mg tablets)
Area Under the Concentration Time Curve [AUC]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: AUC(0-12): Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on days 1 and 6; AUC(0-last): Predose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on day 1 and 6, and additionally 14, 24, 36 and 48h on day 6 only
Time to Maximum Plasma Concentration [Tmax]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1; Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, and 48 hours post last dose on day 6
Maximum Plasma Concentration [Cmax]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1; Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, and 48 hours post last dose on day 6
Minimum Plasma Concentration [Cmin]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 6 only
C0 [Predose]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75 hours) up to Day 8
Half-life [t1/2]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time frame: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, and 48 hours post last dose on day 6 only
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: Up to 20 Days
Participants were recruited at 2 investigational sites. The first participant enrolled was on 13-Jan-2025 and the last participant was enrolled on 24-Jun-2025.
| Milestone | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 7 |
| Not completed | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
| ng.h/mL | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function |
|---|---|---|
| Total ALG-097558 - AUC(0-12) Day 1 | 12700 ± 35.1 | 7620 ± 144 |
| Total ALG-097558 - AUC(0-12) Day 6 | 11600 ± 20.8 | 10600 ± 31.4 |
| Unbound ALG-097558 - AUC(0-12) Day 1 | 1240 ± 28.2 | 628 ± 48.8 |
| Unbound ALG-097558 - AUC(0-12) Day 6 | 1130 ± 39.9 | 648 ± 30.4 |
| Total ALG-097730 - AUC(0-12) Day 1 | 2700 ± 29.8 | 1620 ± 158 |
| Total ALG-097730 - AUC(0-12) Day 6 | 2640 ± 21.7 | 2460 ± 21.1 |
| Unbound ALG-097730 - AUC(0-12) Day 1 | 1000 ± 22.0 | 620 ± 32.7 |
| Unbound ALG-097730 - AUC(0-12) Day 6 | 963 ± 27.4 | 634 ± 20.8 |
| Total ALG-097558 - AUC(0-last) Day 6 | 12800 ± 23.5 | 11400 ± 33.4 |
| Unbound ALG-097558 - AUC(0-last) Day 6 | 1120 ± 41.3 | 593 ± 35.5 |
| Total ALG-097730 - AUC(0-last) Day 6 | 3300 ± 25.8 | 2890 ± 23.2 |
| Unbound ALG-097730 - AUC(0-last) Day 6 | 991 ± 29.0 | 619 ± 23.8 |
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
| hours | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function |
|---|---|---|
| Total ALG-097558 - Tmax Day 1 | 2.00 (0.5 to 3.0) | 2.00 (1.0 to 3.0) |
| Total ALG-097558 - Tmax Day 6 | 2.00 (0.5 to 3.0) | 2.00 (0.5 to 4.0) |
| Total ALG-097730 - Tmax Day 1 | 2.5 (1.0 to 3.0) | 2.00 (2.0 to 4.0) |
| Total ALG-097730 - Tmax Day 6 | 2.50 (1.0 to 4.0) | 3.00 (1.0 to 4.0) |
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
| ng/mL | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function |
|---|---|---|
| Total ALG-097558 - Cmax Day 1 | 3000 ± 39.4 | 1800 ± 135.0 |
| Total ALG-097558 - Cmax Day 6 | 2570 ± 35.5 | 2450 ± 40.2 |
| Unbound ALG-097558 - Cmax Day 1 | 343 ± 19.2 | 161 ± 39.0 |
| Unbound ALG-097558 - Cmax Day 6 | 291 ± 47.1 | 154 ± 32.9 |
| Total ALG-097730 - Cmax Day 1 | 471 ± 33.3 | 299 ± 159 |
| Total ALG-097730 - Cmax Day 6 | 441 ± 28.4 | 448 ± 33.8 |
| Unbound ALG-097730 - Cmax Day 1 | 194 ± 22.1 | 128 ± 23.8 |
| Unbound ALG-097730 - Cmax Day 6 | 179 ± 25.1 | 128 ± 27.0 |
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
| ng/mL | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function |
|---|---|---|
| Total ALG-097558 - Cmin Day 6 | 126 ± 56.4 | 99.0 ± 66.9 |
| Total ALG-097730 - Cmin Day 6 | 55.9 ± 45.3 | 41.8 ± 46.2 |
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
| ng/mL | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function |
|---|---|---|
| Total ALG-097558 - Ctrough Day 2 | 320 ± 55.4 | NA |
| Total ALG-097558 - Ctrough Day 3 | 268 ± 50.8 | 230 ± 63.2 |
| Total ALG-097558 - Ctrough Day 4 | 234 ± 69.4 | 174 ± 36.1 |
| Total ALG-097558 - Ctrough Day 5 | 230 ± 89.3 | 170 ± 46.8 |
| Total ALG-097558 - Ctrough Day 6 | 290 ± 65.1 | 171 ± 40.3 |
| Unbound ALG-097558 - Ctrough Day 2 | 24.1 ± 67.7 | 11.8 ± 47.1 |
| Unbound ALG-097558 - Ctrough Day 3 | 22.5 ± 62.7 | 11.4 ± 33.2 |
| Unbound ALG-097558 - Ctrough Day 4 | 23.3 ± 66.2 | 11.8 ± 23.7 |
| Unbound ALG-097558 - Ctrough Day 5 | 24.3 ± 71.5 | 9.84 ± 4.00 |
| Unbound ALG-097558 - Ctrough Day 6 | 33.9 ± 56.4 | 13.0 ± 29.7 |
| Total ALG-097730 - Ctrough Day 2 | 103 ± 24.8 | NA |
| Total ALG-097730 - Ctrough Day 3 | 97.1 ± 35.8 | 81.7 ± 39.5 |
| Total ALG-097730 - Ctrough Day 4 | 93.6 ± 48.3 | 72.2 ± 30.8 |
| Total ALG-097730 - Ctrough Day 5 | 86.4 ± 48.3 | 69.5 ± 34.6 |
| Total ALG-097730 - Ctrough Day 6 | 97.2 ± 45.3 | 69.9 ± 33.3 |
| Unbound ALG-097730 - Ctrough Day 2 | 32.0 ± 28.1 | 16.7 ± 43.2 |
| Unbound ALG-097730 - Ctrough Day 3 | 31.7 ± 40.5 | 14.3 ± 41.1 |
| Unbound ALG-097730 - Ctrough Day 4 | 33.8 ± 43.6 | 18.1 ± 23.6 |
| Unbound ALG-097730 - Ctrough Day 5 | 30.5 ± 54.4 | 15.5 ± 27.7 |
| Unbound ALG-097730 - Ctrough Day 6 | 36.2 ± 45.7 | 19.5 ± 31.5 |
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
| hours | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function |
|---|---|---|
| Total ALG-097558 - t1/2 Day 6 | 5.74 ± 71.6 | 6.75 ± 36.8 |
| Total ALG-097730 - t1/2 Day 6 | 7.50 ± 82.9 | 9.44 ± 49.1 |
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
| participants | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function |
|---|---|---|
| Any TEAE — Safety Set - Any TEAE | 2 | 1 |
| Any treatment-related TEAE — Safety Set - Any TEAE | 0 | 1 |
| Any Grade ≥3 TEAE — Safety Set - Any TEAE | 1 | 0 |
| Any treatment-related TEAE by severity — Safety Set - Any TEAE | 0 | 1 |
| Any treatment-related TEAE by severity Grade 2 — Safety Set - Any TEAE | 0 | 1 |
| Any treatment-related Grade ≥3 TEAE — Safety Set - Any TEAE | 0 | 0 |
| Any TEAE Leading to Early Discontinuation — Safety Set - Any TEAE | 0 | 1 |
Collected over Up to 20 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | 0/8 (0%) | 1/8 (12.5%) | 1/8 (12.5%) |
| Subjects With Normal Hepatic Function | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Event | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function |
|---|---|---|
| Alcohol Withdrawal SyndromePsychiatric disorders | 1/8 | 0/8 |
| Hepatitis alcoholicHepatobiliary disorders | 1/8 | 0/8 |
| Event | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function |
|---|---|---|
| Abdominal pain upperGastrointestinal disorders | 0/8 | 1/8 |
| DuodenitisGastrointestinal disorders | 1/8 | 0/8 |
| Mallory-Weiss syndromeGastrointestinal disorders | 1/8 | 0/8 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/8 | 0/8 |
| Ligament PainInjury, poisoning and procedural complications | 1/8 | 0/8 |
| Age, Continuous(years) | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function | Total |
|---|---|---|---|
| Mean | 59.4 ± 9.04 | 62.8 ± 3.20 | 61.1 ± 6.78 |
| Sex: Female, Male(Participants) | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 3 | 3 | 6 |
| Race (NIH/OMB)(Participants) | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 8 | 8 | 16 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 5 | 10 |
| Not Hispanic or Latino | 3 | 3 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function | Total |
|---|---|---|---|
| United States | 8 | 8 | 16 |
| Height(centimetres) | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function | Total |
|---|---|---|---|
| Mean | 160.84 ± 9.548 | 164.70 ± 10.081 | 162.77 ± 9.693 |
| Weight(kg) | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function | Total |
|---|---|---|---|
| Mean | 72.25 ± 11.651 | 70.75 ± 7.506 | 71.50 ± 9.499 |
| Body Mass Index(kg/m^2) | Subjects With Moderate Hepatic Impairment (Child-Pughs Class B) | Subjects With Normal Hepatic Function | Total |
|---|---|---|---|
| Mean | 27.79 ± 2.200 | 26.24 ± 3.348 | 27.01 ± 2.851 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2025 to primary completion in Jul 2025, 6 months.
Results were first posted in Aug 2026, 1 year after primary completion.
Of 233 industry-sponsored phase 1 interventional studies under COVID-19, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 12. This study's 6 months is close to that.
Counting every sponsor, half of 384 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ALG-097558
Aligos Therapeutics