Phase 2
Completed N=112
A Study in Participants With Non-cirrhotic NASH With Fibrosis
Non-Cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
Source: ClinicalTrials.gov NCT05638737 ↗
Enrolled (actual)
112
Serious AEs
2.7%
Results posted
Jul 2025
Primary outcomePrimary: Relative to Baseline Alanine Aminotransferase (ALT) — 0.959; 0.895 Ratio — p=0.893
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.
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 |
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. Informational only — not medical advice.