Last reviewed · How we verify
A Study in Participants With Non-cirrhotic NASH With Fibrosis
Phase 2 trial testing AZD4831 in Non-Cirrhotic Non-alcoholic Steatohepatitis With Fibrosis in 112 participants. Completed in 4 April 2024.
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 112 |
| Start date | 26 October 2022 |
| Primary completion | 4 April 2024 |
| Estimated completion | 4 April 2024 |
| Sites | 65 locations across Denmark, Italy, Sweden, Mexico, Norway, Argentina, Portugal, United States |
AstraZeneca — full company profile →
Adults 18 to 75, any sex, with Non-Cirrhotic Non-alcoholic Steatohepatitis With Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
ALT at 12 weeks relative to baseline. ALT is measured in Units per litre (U/L)
| Group | Value | 95% CI |
|---|---|---|
| Mitiperstat (5mg) | 0.959 | 0.885 – 1.040 |
| Placebo | 0.895 | 0.824 – 0.972 |
Pro-C3 at 12 weeks relative to baseline. Pro-C3 is measured in nanograms per milliliter (ng/mL).
| Group | Value | 95% CI |
|---|---|---|
| Mitiperstat (5mg) | 1.009 | 0.960 – 1.060 |
| Placebo | 1.018 | 0.971 – 1.068 |
Time frame: Adverse events was collected from time of first dose throughout the treatment period and including the follow-up period, a planned period of 16 weeks. The only exception is related to the predose orthostatic test at Visit 4: If orthostatic hypotension was confirmed, it would be reported as an AE, and symptoms related to the measurement of orthostatic vitals if present should also be reported as an AE.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment | Placebo |
|---|---|---|---|
| Bronchitis | Infections and infestations | — | — |
| Herpes zoster | Infections and infestations | — | — |
| Pneumonia | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Treatment | Placebo |
|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Influenza | Infections and infestations | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Dizziness | Nervous system disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Faeces hard | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Covid-19 | Infections and infestations | — | — |
| Blood creatine phosphokinase increased | Investigations | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Food poisoning | Gastrointestinal disorders | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — |
| Haemorrhagic erosive gastritis | Gastrointestinal disorders | — | — |
| Haemorrhoids | Gastrointestinal disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Toothache | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Illness | General disorders | — | — |
| Influenza like illness | General disorders | — | — |
| Non-cardiac chest pain | General disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| Hepatitis alcoholic | Hepatobiliary disorders | — | — |
| Allergy to arthropod bite | Immune system disorders | — | — |
| Food allergy | Immune system disorders | — | — |
| Abscess | Infections and infestations | — | — |
| Gastroenteritis viral | Infections and infestations | — | — |
| Hordeolum | Infections and infestations | — | — |
| Oral herpes | Infections and infestations | — | — |
Most-reported serious reactions: Bronchitis, Herpes zoster, Pneumonia, Sepsis, Chronic obstructive pulmonary disease.
Data from ClinicalTrials.gov NCT05638737 adverse events section.
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05638737.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing