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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 have the PNPLA3 rs738409 148M Genetic Marker.
EU CTIS ID: 2023-509704-14-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 who are carriers for the PNPLA3 rs738409 148M risk allele.
- 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: (a) Definitive NASH with NAS ≥ 4 with ≥ 1 in each component (ie, steatosis, lobular inflammation, and ballooning). (b) Presence of fibrosis stage F2 or F3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation
You likely can't join if
- 1 Liver disease of other aetiologies (eg,alcoholic steatohepatitis; drug-induced, viral or autoimmune hepatitis; primary biliary cirrhosis; primary sclerosing cholangitis; hemochromatosis; alpha-1 antitrypsin deficiency; Wilson’s disease)
- 2 History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy, or variceal bleeding
- 3 Historical persistent or pre-existing renal disease marked by eGFR < 40 mL/min/1.73 m2 (as defined by Kidney Disease Improving Global Outcomes guidelines)
- 4 Confirmed platelet count
- 5 Any of the following confirmed at the screening visit: (a) ALT > 5.0 × ULN (b) TBL > 1.5 mg/dL (TBL > 1.5 mg/dL is allowed if conjugated bilirubin is < 1.5 × ULN) (c) INR > 1.3 (d) ALP > 1.5 × ULN (unless the ALP elevation is not from hepatic origin as determined by abone-specific ALP)
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- Korea, Republic of
- Peru
- Malaysia
- Turkey
- Taiwan
- Brazil
- Colombia
- Singapore
- Philippines
- India
- United States
- Vietnam
- Mexico
- Hong Kong
- Japan
- Argentina
- Chile
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; Korea, Republic of; Peru; Malaysia; Turkey; Taiwan and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.