ALG-097558 for Kidney Failure

No longer recruiting at 2 trial locations

Overseen By Jen Rito

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Aligos Therapeutics

Disqualifiers: Cardiac disease, Drug abuse, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how kidney problems affect the body's processing of a new drug called ALG-097558, an experimental treatment. Participants will take the medication twice a day for six days, and researchers will observe its behavior in individuals with and without kidney issues. The trial is suitable for those with kidney problems who do not require dialysis, as well as those without kidney issues. Participants with stable medications for other health conditions might also be eligible. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have impaired kidney function, you must have been on stable medications for at least 28 days before the trial.

Is there any evidence suggesting that ALG-097558 is likely to be safe for humans?

Research shows that ALG-097558 is being tested for safety and how the body processes it, particularly in individuals with kidney problems. Earlier studies found that ALG-097558 was generally well-tolerated, with most participants experiencing no serious side effects from either single or multiple doses.

This study is in its early phase, marking the first time ALG-097558 is tested in humans. This phase focuses on ensuring the treatment's safety and determining the correct dosage. Although detailed safety data for this specific trial is not yet available, the absence of serious side effects in previous studies is promising.

Prospective participants should know that this phase is designed to closely monitor safety and any potential side effects. Researchers will carefully observe participants to ensure their well-being throughout the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for kidney failure?

ALG-097558 is unique because it offers a new approach to treating kidney failure, which typically relies on dialysis or kidney transplantation. Unlike these options, ALG-097558 is an oral medication that could potentially simplify treatment by allowing patients to take a pill instead of undergoing complex procedures. Researchers are particularly excited because this drug could work more efficiently by targeting kidney function directly and could be suitable for patients with various levels of renal impairment, making it a versatile option in kidney failure management.

What evidence suggests that ALG-097558 might be an effective treatment for kidney failure?

Research has shown that ALG-097558 could be a promising treatment by blocking a specific enzyme involved in certain diseases. Early lab tests indicate that ALG-097558 is effective, which is a positive initial sign. Evidence also suggests it might help people recover faster. However, limited information is available from human studies. The current study primarily focuses on understanding how the drug works in the body, particularly in individuals with varying degrees of kidney function, including those with normal renal function and those with mild, moderate, or severe renal impairment. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with severe kidney failure and healthy individuals with normal kidney function, ideally matched by age, weight, and if possible, gender. Specific eligibility criteria are not provided but typically include factors like stable health status and no conflicting medications or conditions.

Inclusion Criteria

Body Mass Index (BMI) 17.5 to 40.0 kg/m^2 and a total body weight >50 kg (110 lb)

I am not able to have children or will use effective birth control.

Exclusion Criteria

Positive pregnancy test; females must not be pregnant at enrollment

My hemoglobin is below 9 g/dL and I have kidney issues.

I do not have active Hepatitis A, B, C, E, HIV, or COVID-19.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral doses of 300 mg ALG-097558 twice daily for 6 days

1 week

Daily visits for dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ALG-097558

Trial Overview The study is testing ALG-097558's behavior in the body (pharmacokinetics) when given orally twice a day to people with severe renal impairment compared to those without. It aims to understand how kidney function affects the drug's processing.

How Is the Trial Designed?

Group I: Subjects with Severe Renal Impairment Experimental Treatment 1 Intervention

Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Group II: Subjects with Normal Renal Function Experimental Treatment 1 Intervention

Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Group III: Subjects with Moderate Renal Impairment (Optional) Experimental Treatment 1 Intervention

Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Group IV: Subjects with Mild Renal Impairment (Optional) Experimental Treatment 1 Intervention

Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Who Is Running the Clinical Trial?

Aligos Therapeutics

Lead Sponsor

Trials

11

Recruited

960+

Founded

2018

Headquarters

South San Francisco, United States

Known For

Liver & Viral Therapies

Top Products

ALG-000184, ALG-055009, ALG-097558

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Citations

1. withpower.com withpower.com/trial/phase-1-renal-insufficiency-2025-40b31

ALG-097558 for Kidney Failure · Info for Participants The primary purpose of this study is to characterize the effect of renal impairment on the plasma pharmacokinetics of ALG-097558 following administration of ...

2. trial.medpath.com trial.medpath.com/clinical-trial/b612036c8d65ebbc/nct06698549-pharmacokinetics-safety-tolerability-alg-097558-renal-impairment

A Study to Evaluate the Pharmacokinetics, Safety ... - MedPath The primary purpose of this study is to characterize the effect of renal impairment on the plasma pharmacokinetics of ALG-097558 following administration of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04746183

AGILE (Early Phase Platform Trial for COVID-19) Candidate-Specific Trial 9 (CST-9a): A multicentre, adaptive Phase II Platform trial to evaluate the safety, efficacy and virological response of ALG-097558 as ...

4. isrctn.com isrctn.com/pdf/27106947

A study to assess several different treatments that may be ... ALG-097558 of 600 mg twice daily. (Q12H) for 5 days in this study may result in clinically meaningful efficacy outcomes (e.g., shorter time to ...

5. iasusa.org iasusa.org/wp-content/uploads/2025/06/june-2025.pdf

Topics in Jekle and colleagues (Abstract 711) presented pre- clinical data on ALG-097558, another 3CLpro inhibitor, demonstrating in vitro efficacy of the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05840952

NCT05840952 | A First-in-Human Multi-Part Phase 1 Study ... ... Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558. ClinicalTrials.gov ID NCT05840952.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10085722/

Safety and efficiency of molnupiravir for COVID-19 patients ... No adverse effects were observed in any patient. Renal function remained stable in the two CKD patients who were not on dialysis (Table 1). One month after ...