[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559473":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":35,"centralContacts":39,"locations":45,"responsibleParty":80,"collaborators":30,"id":82,"slug":30,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":30,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":30,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":30,"overallStatus":48,"whyStopped":30,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"OrsoBio, Inc","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"TLC-2716 Dose 1","EXPERIMENTAL","Oral dose of TLC-2716 Dose 1",[13],"Drug: TLC-2716 Dose 1",{"label":15,"type":10,"description":16,"interventionNames":17},"TLC-2716 Dose 2","Oral dose of TLC-2716 Dose 2",[18],"Drug: TLC-2716 Dose 2",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","Oral dose of placebo-to-match",[24],"Drug: Placebo",[26,31,33],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Capsules administered orally",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":32,"otherNames":30},[15],{"type":27,"name":20,"description":28,"armGroupLabels":34,"otherNames":30},[20],[36],{"name":37,"affiliation":5,"role":38},"OrsoBio Study Director","STUDY_DIRECTOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Ryan Huss, MD","CONTACT","650-382-2225","Clinicaltrials_Inquires@orsobio.com",[46,59,67,75],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":30},"OrsoBio Research Site","RECRUITING","Guadalajara","Jalisco","45116","Mexico",{"type":54,"coordinates":55},"Point",[56,57],-103.34749,20.67738,{"lat":57,"lon":56},{"facility":47,"status":48,"city":60,"state":50,"zip":61,"country":52,"cosmosGeoPoint":62,"geoPoint":66,"contacts":30},"Zapopan","45170",{"type":54,"coordinates":63},[64,65],-103.38742,20.72111,{"lat":65,"lon":64},{"facility":47,"status":48,"city":68,"state":68,"zip":69,"country":52,"cosmosGeoPoint":70,"geoPoint":74,"contacts":30},"Mexico City","06700",{"type":54,"coordinates":71},[72,73],-99.12766,19.42847,{"lat":73,"lon":72},{"facility":47,"status":48,"city":68,"state":68,"zip":76,"country":52,"cosmosGeoPoint":77,"geoPoint":79,"contacts":30},"14080",{"type":54,"coordinates":78},[72,73],{"lat":73,"lon":72},{"type":81,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100559473",false,"NCT06564584","Phase 2a Study of Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and NAFLD","A Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and Nonalcoholic Fatty Liver Disease","Inclusion Criteria:\n\n* BMI ≥ 28 kg\u002Fm2 at Screening\n* Fasting TG ≥ 350 mg\u002FdL\n* Subjects without diabetes or subjects with diabetes and HbA1c \\\u003C 9.5% at Screening\n* Screening laboratory evaluations (eGFR, ALT, AST, INR, total bilirubin, platelet count) must fall within the protocol-defined ranges\n* A clinical diagnosis of NAFLD\u002FNASH within 5 years of Screening based on historical hepatic imaging (e.g., ultrasound, MRI, computed tomography \\[CT\\], or Controlled Attenuation Parameter \\[CAP\\] by vibration-controlled transient elastography ≥ 250 dB\u002Fm), and no documented weight loss \\> 5% between the date of the historical hepatic imaging and Screening OR a historical liver biopsy within 5 years of Screening consistent with NAFLD\u002FNASH without cirrhosis and no documented weight loss \\> 5% between the date of the historical liver biopsy and Screening\n* Normotensive subjects or subjects without uncontrolled hypertension, defined as systolic blood pressure \\> 155 mmHg and\u002For diastolic blood pressure \\> 90 mmHg at Screening\n* A 12-lead electrocardiogram (ECG) at Screening that is normal or with abnormalities that are considered not clinically significant by the investigator\n* Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to first dose of study drug\n* Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception\n\nExclusion Criteria:\n\n* HbA1c ≥ 9.5% at Screening\n* Weight loss \\> 5% during the 90 days prior to Screening\n* Pregnant or lactating subjects.\n* Current alcohol abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety\n* Current substance abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety\n* A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen, or hepatitis C (HCV) antibody\n* Medical history of liver disease other than NAFLD\u002FNASH, including but not limited to, alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency.\n* Any history of cirrhosis or decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding, or Child-Pugh-Turcotte score \\> 6 at Screening\n* Unstable cardiovascular disease\n* History of intestinal resection or malabsorptive condition that may limit the absorption of study drug. Appendectomy and cholecystectomy are not exclusionary.\n* Presence of severe peptic ulcer, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions at Screening, in the opinion of the investigator\n* Any scheduled surgery during the trial period, excluding minor surgical procedures performed under local anesthesia, in the opinion of the investigator\n* History of malignancy within 5 years prior to Screening except adequately treated carcinoma in situ of the cervix, and\u002For squamous cell cancer, or other localized non-melanoma skin cancer\n* History of significant drug allergy, such as anaphylaxis or significant drug sensitivity, in the opinion of the investigator\n* Known hypersensitivity to study drug, its metabolites, or formulation excipients\n* Presence of any medical condition that could, in the opinion of the investigator, compromise the subject's ability to participate in the study, including a history of substance abuse or a psychiatric disorder, including any subject with a psychiatric hospital admission or emergency room visit in the 2 years prior to Screening\n* Any laboratory abnormality that in the opinion of the investigator could adversely affect the safety of the subject or impair assessment of study results\n* Medications or therapies prescribed or taken over-the-counter for weight loss, in the 90 days prior to Screening\n* Receipt of vaccination for COVID-19 or any other live vaccine within 14 days of planned dosing of study drug\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply","ALL","18 Years","70 Years",{"count":92,"type":93},30,"ESTIMATED","INTERVENTIONAL",[96],"PHASE2","This is a Phase 2a, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of 2 dose levels of TLC-2716 in subjects with hypertriglyceridemia and nonalcoholic fatty liver disease as assessed by changes in fasting triglycerides, liver steatosis by MRI, and other biomarkers.",[99,100],"Hypertriglyceridemia","Nonalcoholic Fatty Liver Disease","2025-03-31",{"date":103,"type":104},"2025-04-03","ACTUAL",{"date":106,"type":104},"2024-08-12",{"date":108,"type":93},"2025-09",{"name":5,"class":6},4]