Phase 2
N=112
A Study in Participants With Non-cirrhotic NASH With Fibrosis
Non-Cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT05638737 ↗Enrolled (actual)
112
Serious AEs
2.7%
Results posted
Jul 2025
Primary outcome: Primary: Relative to Baseline Alanine Aminotransferase (ALT) — 0.959; 0.895 Ratio — p=0.893
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD4831 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative to Baseline Alanine Aminotransferase (ALT) |
0.959; 0.895 | 0.893 |
| SECONDARY Relative to Baseline Pro-C3 |
1.009; 1.018 | 0.396 |
Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Participants will be in the trial for up to 24 weeks, including a screening period lasting up to 8 weeks, a 12-week treatment period, and a 4-week safety follow-up period
Participants are not expected to directly benefit from treatment during this trial. Participants will help researchers learn more about and how to develop AZD4831 to treat NASH.
Eligibility Criteria
Inclusion Criteria
- Participant must be ≥ 18 to ≤ 75 years of age at the time of signing the informed consent.
- Histological confirmed NASH per Clinical Research Network (CRN) criteria as diagnosed by liver biopsy (within 12 months prior screening, participants without historical biopsy should be willing to undergo a liver biopsy at screening) fulfilling all of the following criteria:
- NAS ≥ 4 with a score of ≥ 1 for each component: steatosis, lobular inflammation and ballooning
- Presence of fibrosis F1, F2-F3
- One increased serum ALT measurement (ALT > ULN) at screening, and historical local serum ALT level (> ULN [41 U/L for men and 31 U/L for women] but 21 drinks/week for males or > 14 drinks/week for females. One drink is equivalent to 14 g alcohol.
- Recent (within 3 months of randomization) use of drugs approved for weight loss (eg, orlistat, bupropion/naltrexone, phentermine-topiramate, phentermine, lorcaserin), as well as those drugs used off-label.
- High dose vitamin E (> 400 IU) unless on a stable dose within 6 months of screening.
- Recent (within 6 months of screening) use of therapies associated with development of NAFLD (eg, systemic corticosteroids, methotrexate, tamoxifen, amiodarone, or long-term use of tetracyclines).
- Recent (within 6 months of screening) use of obeticholic acid or other therapy under investigation for NASH.
Data sourced from ClinicalTrials.gov (NCT05638737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.