LW231 treatment for people with chronic hepatitis B
Official title: Phase Ib/II Study of LW231 in Patients With Chronic Hepatitis B: Evaluation of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy With Multiple-Dose, Dose-Escalation, and Combination With Nucleos(t)Ide Analogs (NUC)
Run by Shanghai Longwood Biopharmaceuticals Co., Ltd. · NCT07179575 · Data updated 2026-11-12
This trial tests whether LW231, given alone or with standard antiviral NUCs, is safe and can lower hepatitis B virus measures in adults with chronic HBV.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 270 (estimated) |
| Sponsor | Shanghai Longwood Biopharmaceuticals Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Hangzhou, Zhejiang and 1 other locations) |
| Status | Recruiting |
| Started | November 11, 2025 |
| Main results expected | March 2027 |
| Study ends | November 2027 |
| Registry record updated | August 26, 2026 |
| Trial ID | NCT07179575 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with chronic HBV who meet the trial viral-load and HBsAg ranges (part 1: LLOQ < HBV DNA ≤ 20,000 IU/mL and HBsAg 100–10,000 IU/mL; part 2: HBV DNA < LLOQ or < 20 IU/mL and HBsAg 100–3,000 IU/mL) and who do not have cirrhosis or other exclusionary conditions.
✕Probably not a fit
People with co-infections (HAV, HCV, HDV, HEV, or HIV), cirrhosis, or significant liver test abnormalities are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase Ib/II, multicenter, randomized dose-escalation trial will give multiple doses of LW231 and compare active drug to placebo, including arms that combine LW231 with nucleos(t)ide analogs (NUCs). The study will collect safety, tolerability, pharmacokinetic, and pharmacodynamic data as well as preliminary efficacy signals such as reductions in HBV DNA and HBsAg. Participants include both treatment-naïve patients with low-to-moderate viremia and patients already suppressed on NUCs but with measurable HBsAg. Regular clinic visits and laboratory monitoring will be used to track adverse events and antiviral responses over the dosing and follow-up periods.
Why it matters
Potential benefit: If successful, LW231 could offer a new treatment option that better suppresses HBV and lowers HBsAg, potentially improving chances for long-term viral control.
How similar studies have gone: Other early-phase trials combining novel antivirals with NUCs have shown promising antiviral activity, but a broadly effective cure for chronic HBV has not yet been established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Part 1: treatment-naïve and currently not treated subjects: LLOQ\<HBV DNA≤20000 IU/ml; 100 IU/mL\<HBsAg\<10000 IU/ml * Part 2: HBV DNA\<LLOQ or \< 20 IU/mL at screening; 100 IU/mL\<HBsAg\<3000 IU/mL Exclusion Criteria: * Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology. * History or current evidence of cirrhosis. * ALT or AST\>3×ULN; TBil\>1.3×ULN or DBil\>1.3×ULN; INR\>1.3×ULN
Where it's running
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting -
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China Not yet recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.