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ALG-000184 versus tenofovir for adults with chronic hepatitis B

A Randomized, Double-Blind, Active-Controlled Multicenter Phase 2 Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg-Negative Adult Subjects With Chronic Hepatitis B Virus Infection (B-SUPREME)

Phase 2 Interventional Aligos Therapeutics · NCT06963710

This 48-week, once-daily oral treatment tests whether ALG-000184 works as well as tenofovir in adults with chronic hepatitis B who are treatment‑naïve or off therapy.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorAligos Therapeutics Industry-sponsored
Locations58 sites (Chandler, Arizona and 57 other locations)
Trial IDNCT06963710 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, active-controlled, multicenter Phase 2 comparison of once-daily oral ALG-000184 versus tenofovir disoproxil fumarate (TDF) given for 48 weeks. Approximately 200 adults will be enrolled in two parts: one for HBeAg-positive subjects and one for HBeAg-negative subjects, each allowing an exploratory liver biopsy substudy. Eligible participants are treatment‑naïve or have been off approved or investigational HBV therapies for at least six months and must meet viral load and lab criteria. After the 48-week blinded period, participants may roll over into a 48-week open-label extension in which all receive ALG-000184.

Who should consider this trial

Good fit: Adults 18–65 with chronic hepatitis B (HBeAg-positive or negative), detectable HBsAg, HBV DNA ≥20,000 IU/mL, BMI 18–35 kg/m2, ALT ≤8×ULN, and who are treatment‑naïve or have not received antiviral or investigational HBV therapy within the prior six months.

Not a fit: People recently treated with HBV antivirals or investigational agents, those with HBV DNA below enrollment thresholds, decompensated liver disease, or who fall outside the age/BMI criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, ALG-000184 could provide a new oral treatment option with a different antiviral mechanism that may improve viral suppression compared with current nucleos(t)ide therapy.

How similar studies have performed: Other capsid assembly modulators have shown potent reductions in HBV DNA in early trials but monotherapy has rarely produced high rates of functional cure, so this approach builds on partial prior success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2 (or minimun age by local regulatory requirements).
2. HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).
3. HBsAg ≥LLOQ.
4. HBV DNA ≥20,000 IU/mL.
5. A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening.
6. Must have the following chronic hepatitis B virus infection treatment status at screening:

   1. Have never received treatment with HBV antiviral medicines (NA, interferon) or investigational anti-HBV agents including a CAM \[i.e., Treatment Naïve (TN) subjects\], OR
   2. Have not been on treatment with approved (NA, interferon) or investigational HBV antiviral medicines (e.g., antisense oligonucleotides or small interfering RNAs) within 6 months or 5 half-lives (whichever is longer) prior to randomization (i.e., Currently Not Treated (CNT) subjects).

Key Exclusion Criteria:

1. Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.
2. Positive for anti-HBs antibodies.
3. History or current evidence of cirrhosis.
4. Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.
5. History of, or current evidence of, hepatic decompensation.
6. Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.
7. Having received an investigational medicinal product or device within 4 weeks (or 5 half-lives, whichever is longer) before the planned first dose of study drug
8. Exclusionary screening laboratory values include:

   1. Aspartate aminotransferase (AST) \>8×ULN,
   2. Bilirubin (total, direct) \>1.2×ULN (unless Gilbert's syndrome is suspected)
   3. International Normalization Ratio (INR) \>1.2×ULN

Where this trial is running

Chandler, Arizona and 57 other locations

+8 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Hepatitis B InfectionCapsid Assembly ModulatorsCAMsCHBHBVChronic Hepatitis BHepatitis B InfectionHepatitis B
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.