A Phase 2 interventional study of AZD2693 and Placebo in Nonalcoholic Steatohepatitis, sponsored by AstraZeneca. Completed at 164 sites in 22 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-10-28.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M Risk Allele
1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's enrollment of 220 is above the median of 60 across 1,072 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria :
Participants are eligible to be included in the study only if all the following criteria apply:
Age
Participant must be 18 to 75 years of age (inclusive) at the time of signing the informed consent.
Type of Participant and Disease Characteristics
Participants with histological evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 6 months before randomisation, or during screening, fulfilling both criteria:
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Key Exclusion Criteria :
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
Any of the following confirmed at the screening visit:
Participants will receive AZD2693 dose 1
Drug: AZD2693
Participants will receive AZD2693 dose 2
Drug: AZD2693
Participants in this arm will receive placebo
Other: Placebo
AZD2693 solution SC once per month
Sodium chloride 0.9% solution SC once per month
Proportion of participants achieving NASH resolution without worsening of fibrosis based on histology after 52 weeks treatment
To assess the effect of AZD2693 versus placebo on histological resolution of NASH in participants with non-cirrhotic NASH with fibrosis and PNPLA3 risk allele carriers after 52 weeks
Time frame: after 52 weeks
Proportion of participants with at least one stage of liver fibrosis improvement with no worsening of NASH based on biopsy after 52 weeks treatment
To assess the effects of AZD2693 versus placebo on histological fibrosis improvement
Time frame: after 52 weeks
Proportion of participants with ≥ 2-point improvement from baseline in NAS based on biopsy after 52 weeks treatment
To assess the effect of AZD2693 versus placebo on ≥ 2-point improvement in NAS
Time frame: after 52 weeks
Proportion of participants with improvement in fibrosis by at least one stage based on biopsy after 52 weeks treatment
To assess the effect of AZD2693 versus placebo on improvement in fibrosis by at least one stage
Time frame: after 52 weeks
Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal laboratory test results
Haematology, urinalysis, clinical chemistry and eGFR
Time frame: 64 weeks
Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal clinical test results
Vital signs and electrocardiogram (ECG) assessments
Time frame: 64 weeks
Showing the first 100 of 164 sites across 22 countries.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease→
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