Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
The purpose of this study is to evaluate the safety, tolerability, and pharmacodynamic effects of AZD2389 in adult participants with steatotic liver disease (SLD) and advanced fibrosis.
Eligibility criteria
Qualifiers
Males/females aged 18 or over
A diagnosis of SLD with advanced fibrosis
No significant change in weight over the last 6 months
Contraceptive us by participants or participants partners
Disqualifiers
Portal hypertension (LSM >25 kPa or 20-25 kPa with platelets <150×10⁹/L), decompensated liver disease, Child-Pugh >A6, MELD >12, other chronic liver diseases, prior/planned liver transplant, or malignant liver tumors.
Positive viral infections, including HIV or hepatitis B, or hepatitis C unless HCV RNA-negative ≥12 weeks after treatment.
Alcohol intake above protocol thresholds, or positive screen for drugs of abuse.
Significant metabolic, cardiovascular, or GI disorders, including T1DM or insulin-treated T2DM, uncontrolled hypertension, recent major cardiac/cerebrovascular events, severe heart failure, serious arrhythmias, significant pancreatic disease, or major GI surgery.
Trial design
Treatments tested in this trial
- AZD2389
- Placebo
Treatment groups
104 Participants
are divided into 2 treatment groupsLocations
20Arizona
Research Site85224, Chandler United States
Research Site85712, Tucson United States
Florida
Research Site33458, Jupiter United States
Research Site33122, Miami United States
Sponsors and collaborators
AstraZeneca
Lead sponsor
Source ClinicalTrials.gov