[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07610837":3,"trial-entities:NCT07610837":261,"trial-summary:NCT07610837":265},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":44,"secondary_outcomes":87,"sex":101,"minimum_age":102,"maximum_age":103,"healthy_volunteers":104,"eligibility_criteria":105,"std_ages":123,"locations":126,"central_contacts":252,"overall_officials":258,"references":259,"see_also_links":260},"NCT07610837","D7930C00008","Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis","A Phase IIa, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD2389 in Adult Participants With Steatotic Liver Disease and Advanced Fibrosis (BRAVO)","RECRUITING","2027-07-07","2026-07","2026-07-29","2026-05-07","AstraZeneca","INDUSTRY",true,"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.","Study details include:\n\n* The study duration will be approximately 32 weeks, including screening duration of 4 weeks, the treatment duration of up to 24 weeks, and follow-up period of 4 weeks.\n* The visit frequency will be approximately every 4 weeks except from Visit 2 to Visit 4, which is every 2 weeks.\n\nDisclosure Statement:\n\nThis is a parallel group treatment study that is blinded to the participants and investigators.\n\nNumber of Participants:\n\nApproximately 230 participants with SLD and advanced fibrosis will be screened such that approximately 104 participants will be randomised. Approximately 52 participants will be randomised to receive AZD2389 and approximately 52 participants will receive placebo.\n\nNote: 'Screened' means a participant's, or their legally authorised representative's, agreement to participate in a clinical study following completion of the informed consent process.\n\nStudy Arms and Duration:\n\nArm A will include 52 participants with SLD and advanced fibrosis who will receive oral AZD2389 for 24 weeks. Arm B will include 52 participants with SLD and advanced fibrosis who will receive oral placebo for 24 weeks.",[19,20],"Liver Fibrosis","Hepatic Cirrhosis",[19,20],"INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},104,"ESTIMATED",[30,38],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","AZD2389","potent, selective, first-in-class, small molecule oral inhibitor of FAP and is being developed for the treatment of CLDs with advanced hepatic fibrosis including cirrhosis.",[35],"Arm A",[37],"Active IMP",{"type":39,"name":40,"description":41,"armGroupLabels":42},"OTHER","Placebo","Oral administration",[43],"Arm B",[45,49,53,56,59,62,65,68,71,74,77,79,81,83,85],{"measure":46,"description":47,"timeFrame":48},"Absolute change in Enhanced Liver Fibrosis (ELF) score from baseline to week 24","To evaluate the effects of AZD2389 versus placebo on improvement in ELF score. Lowered ELF scores would suggest better outcome.\n\nNote: ELF is not bounded, i.e. there are no minimum and maximum values","24 weeks",{"measure":50,"description":51,"timeFrame":52},"Reported quantity and severity of adverse events (AEs)","To assess the safety and tolerability of AZD2389 in participants with SLD and advanced fibrosis","Up to and including Day 197",{"measure":54,"description":55,"timeFrame":52},"Number of participants with observed changes in blood pressure against baseline mmHg value","Assess blood pressure level (with systolic and diastolic pressure) in mmHg",{"measure":57,"description":58,"timeFrame":52},"Number of participants with identified abnormalities in results of 12-lead safety electrocardiograms (ECG)","12-lead safety ECG (PR interval, QRS complex, ST interval, T wave)",{"measure":60,"description":61,"timeFrame":52},"Number of participants with abnormal laboratory results detected in urine samples","Urinalysis - Paper chromatography",{"measure":63,"description":64,"timeFrame":52},"Number of participants with observed changes in heart rate (BPM) against baseline value","Pulse rate measured in beats per minute (BPM)",{"measure":66,"description":67,"timeFrame":52},"Number of participants with observed changes in Sp02 oxygen values against baseline measurement","Sp02 oxygen saturations measured by percentage",{"measure":69,"description":70,"timeFrame":52},"Number of participants with observed changes in body temperature against baseline value","Body temperature measured in degrees Celsius",{"measure":72,"description":73,"timeFrame":52},"Number of participants with observed changes in respiratory rate against baseline value","Respiratory rate measured in respirations per minute",{"measure":75,"description":76,"timeFrame":52},"Number of participants with abnormal laboratory test results detected in blood samples","Hematology - Platelets (x10\\^9\u002FL)",{"measure":75,"description":78,"timeFrame":52},"Coagulation - INR",{"measure":75,"description":80,"timeFrame":52},"Clinical Chemistry - ALT (U\u002FL)",{"measure":75,"description":82,"timeFrame":52},"Fibrinolysis - D-dimer (ng\u002FmL fibrinogen-equivalent units)",{"measure":75,"description":84,"timeFrame":52},"Clinical Chemistry - AST (U\u002FL)",{"measure":75,"description":86,"timeFrame":52},"Clinical Chemistry - ALP (U\u002FL)",[88,91,94,97,99],{"measure":89,"description":90,"timeFrame":48},"Absolute change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24","To assess the effects of AZD2389 versus placebo on improvement in ProC3",{"measure":92,"description":93,"timeFrame":48},"Absolute change in Liver Stiffness Measurement (LSM) from baseline to week 24","To assess the effects of AZD2389 versus placebo on improvement in LSM measured by Vibration-controlled transient elastography (VCTE)",{"measure":95,"description":96,"timeFrame":48},"Absolute change in Controlled Attenuation Parameter (CAP) from baseline to week 24","To assess the effects of AZD2389 versus placebo on improvement in CAP",{"measure":98,"description":90,"timeFrame":48},"Percentage change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24",{"measure":100,"description":93,"timeFrame":48},"Percentage change in Liver Stiffness Measurement (LSM) from baseline to week 24","ALL","18 Years",null,false,{"inclusion":106,"exclusion":113,"raw_text":122},[107,108,109,110,111,112],"Males\u002Ffemales 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","Capable of giving informed consent","Judged by the investigator to be suitable for study",[114,115,116,117,118,119,120,121],"Portal hypertension (LSM \\>25 kPa or 20-25 kPa with platelets \\\u003C150×10⁹\u002FL), decompensated liver disease, Child-Pugh \\>A6, MELD \\>12, other chronic liver diseases, prior\u002Fplanned 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\u002Fcerebrovascular events, severe heart failure, serious arrhythmias, significant pancreatic disease, or major GI surgery.","History of psychosis, bipolar disorder, recent major depression, or suicide attempt\u002Fideation within 1 year.","Bleeding risk or wound-healing concerns, including coagulation disorders, major bleeding history, active wounds or recent major surgery, or severe dermatologic immune conditions.","Prohibited medications or hypersensitivities, including moderate\u002Fstrong CYP3A4 or BCRP\u002FOAT3 inhibitors\u002Finducers, anticoagulants\u002Fantiplatelets (except aspirin ≤81 mg\u002Fday), or hypersensitivity to DPP4 inhibitors.","Other protocol-defined exclusions, including significant abnormal labs (e.g., worsening ALT\u002FAST), recent participation in another IMP study, or investigator judgment of unsuitability.","Key Inclusion Criteria:\n\n* Males\u002Ffemales aged 18 or over\n* A diagnosis of SLD with advanced fibrosis\n* No significant change in weight over the last 6 months\n* Contraceptive us by participants or participants partners\n* Capable of giving informed consent\n* Judged by the investigator to be suitable for study\n\nKey Exclusion Criteria:\n\n* Portal hypertension (LSM \\>25 kPa or 20-25 kPa with platelets \\\u003C150×10⁹\u002FL), decompensated liver disease, Child-Pugh \\>A6, MELD \\>12, other chronic liver diseases, prior\u002Fplanned liver transplant, or malignant liver tumors.\n* Positive viral infections, including HIV or hepatitis B, or hepatitis C unless HCV RNA-negative ≥12 weeks after treatment.\n* Alcohol intake above protocol thresholds, or positive screen for drugs of abuse.\n* Significant metabolic, cardiovascular, or GI disorders, including T1DM or insulin-treated T2DM, uncontrolled hypertension, recent major cardiac\u002Fcerebrovascular events, severe heart failure, serious arrhythmias, significant pancreatic disease, or major GI surgery.\n* History of psychosis, bipolar disorder, recent major depression, or suicide attempt\u002Fideation within 1 year.\n* Bleeding risk or wound-healing concerns, including coagulation disorders, major bleeding history, active wounds or recent major surgery, or severe dermatologic immune conditions.\n* Prohibited medications or hypersensitivities, including moderate\u002Fstrong CYP3A4 or BCRP\u002FOAT3 inhibitors\u002Finducers, anticoagulants\u002Fantiplatelets (except aspirin ≤81 mg\u002Fday), or hypersensitivity to DPP4 inhibitors.\n* Other protocol-defined exclusions, including significant abnormal labs (e.g., worsening ALT\u002FAST), recent participation in another IMP study, or investigator judgment of unsuitability.",[124,125],"ADULT","OLDER_ADULT",[127,136,142,149,155,161,168,174,181,188,194,201,208,215,222,228,234,240,243,249],{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":132,"geoPoint":133},"Research Site","Chandler","Arizona","85224","United States",{"lat":134,"lon":135},33.30616,-111.84125,{"facility":128,"status":8,"city":137,"state":130,"zip":138,"country":132,"geoPoint":139},"Tucson","85712",{"lat":140,"lon":141},32.22174,-110.92648,{"facility":128,"status":8,"city":143,"state":144,"zip":145,"country":132,"geoPoint":146},"Jupiter","Florida","33458",{"lat":147,"lon":148},26.93422,-80.09421,{"facility":128,"status":8,"city":150,"state":144,"zip":151,"country":132,"geoPoint":152},"Miami","33122",{"lat":153,"lon":154},25.77427,-80.19366,{"facility":128,"status":8,"city":156,"state":144,"zip":157,"country":132,"geoPoint":158},"Port Orange","32127",{"lat":159,"lon":160},29.13832,-80.99561,{"facility":128,"status":8,"city":162,"state":163,"zip":164,"country":132,"geoPoint":165},"Kansas City","Missouri","64131",{"lat":166,"lon":167},39.09973,-94.57857,{"facility":128,"status":8,"city":169,"state":163,"zip":170,"country":132,"geoPoint":171},"St Louis","63123",{"lat":172,"lon":173},38.62727,-90.19789,{"facility":128,"status":8,"city":175,"state":176,"zip":177,"country":132,"geoPoint":178},"Las Vegas","Nevada","89106",{"lat":179,"lon":180},36.17497,-115.13722,{"facility":128,"status":8,"city":182,"state":183,"zip":184,"country":132,"geoPoint":185},"Morehead City","North Carolina","28557",{"lat":186,"lon":187},34.72294,-76.72604,{"facility":128,"status":8,"city":189,"state":183,"zip":190,"country":132,"geoPoint":191},"Raleigh","27607",{"lat":192,"lon":193},35.7721,-78.63861,{"facility":128,"status":8,"city":195,"state":196,"zip":197,"country":132,"geoPoint":198},"Westlake","Ohio","44145",{"lat":199,"lon":200},41.45532,-81.91792,{"facility":128,"status":8,"city":202,"state":203,"zip":204,"country":132,"geoPoint":205},"Yukon","Oklahoma","73099",{"lat":206,"lon":207},35.50672,-97.76254,{"facility":128,"status":8,"city":209,"state":210,"zip":211,"country":132,"geoPoint":212},"Clarksville","Tennessee","37040",{"lat":213,"lon":214},36.52977,-87.35945,{"facility":128,"status":8,"city":216,"state":217,"zip":218,"country":132,"geoPoint":219},"Austin","Texas","78757",{"lat":220,"lon":221},30.26715,-97.74306,{"facility":128,"status":8,"city":223,"state":217,"zip":224,"country":132,"geoPoint":225},"Denison","75020",{"lat":226,"lon":227},33.75566,-96.53666,{"facility":128,"status":8,"city":229,"state":217,"zip":230,"country":132,"geoPoint":231},"Georgetown","78626",{"lat":232,"lon":233},30.63269,-97.67723,{"facility":128,"status":8,"city":235,"state":217,"zip":236,"country":132,"geoPoint":237},"Houston","77004",{"lat":238,"lon":239},29.76328,-95.36327,{"facility":128,"status":8,"city":235,"state":217,"zip":241,"country":132,"geoPoint":242},"77079",{"lat":238,"lon":239},{"facility":128,"status":8,"city":244,"state":217,"zip":245,"country":132,"geoPoint":246},"San Antonio","78215",{"lat":247,"lon":248},29.42412,-98.49363,{"facility":128,"status":8,"city":244,"state":217,"zip":250,"country":132,"geoPoint":251},"78222",{"lat":247,"lon":248},[253],{"name":254,"role":255,"phone":256,"email":257},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[],[],[],{"nct_id":4,"conditions":262,"biomarkers":264},[263,19],"Hepatic Steatosis",[],{"nct_id":4,"found":15,"summary":266,"prompt_version":276},{"design":267,"status":268,"heading":269,"summary":270,"follow_up":271,"word_count":272,"commitments":273,"compensation":274,"drugs_mentioned":275},"This is a blinded study, meaning neither you nor your doctors will know if you are receiving AZD2389 or a placebo (an inactive substance). Approximately 104 participants will be randomly assigned to one of two groups.","completed","Study of AZD2389 for Steatotic Liver Disease with Advanced Fibrosis","This study is testing a new oral medication called AZD2389 for adults with steatotic liver disease (SLD), also known as fatty liver disease, and advanced fibrosis (scarring of the liver). AZD2389 works by targeting a specific protein called FAP that is involved in liver scarring. The main goals are to see how safe AZD2389 is, how well people tolerate it, and if it can improve liver scarring as measured by the Enhanced Liver Fibrosis (ELF) score after 24 weeks. Researchers will also track any side effects and changes in blood pressure. You may be able to join if you are 18 or older, have SLD with advanced fibrosis, and meet other health criteria. The study aims to enroll about 104 participants.","Participants will be followed for 4 weeks after the 24-week treatment period.",121,"The study will last about 32 weeks, including a 4-week screening period, up to 24 weeks of treatment, and a 4-week follow-up. You will have visits approximately every 4 weeks, with some visits every 2 weeks early in the study.","Not stated in the trial record.",[32],"v2"]