Phase 2a Study of Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and NAFLD

Phase 2

Recruiting

• Conditions: Hypertriglyceridemia; Nonalcoholic Fatty Liver Disease

• Registration Number: NCT06564584
• Lead Sponsor: OrsoBio, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:<br><br> - BMI = 28 kg/m2 at Screening<br><br> - Fasting TG = 350 mg/dL<br><br> - Subjects without diabetes or subjects with diabetes and HbA1c < 9.5% at Screening<br><br> - Screening laboratory evaluations (eGFR, ALT, AST, INR, total bilirubin, platelet<br> count) must fall within the protocol-defined ranges<br><br> - A clinical diagnosis of NAFLD/NASH within 5 years of Screening based on historical<br> hepatic imaging (e.g., ultrasound, MRI, computed tomography [CT], or Controlled<br> Attenuation Parameter [CAP] by vibration-controlled transient elastography = 250<br> dB/m), and no documented weight loss > 5% between the date of the historical hepatic<br> imaging and Screening OR a historical liver biopsy within 5 years of Screening<br> consistent with NAFLD/NASH without cirrhosis and no documented weight loss > 5%<br> between the date of the historical liver biopsy and Screening<br><br> - Normotensive subjects or subjects without uncontrolled hypertension, defined as<br> systolic blood pressure > 155 mmHg and/or diastolic blood pressure > 90 mmHg at<br> Screening<br><br> - A 12-lead electrocardiogram (ECG) at Screening that is normal or with abnormalities<br> that are considered not clinically significant by the investigator<br><br> - Female subjects of childbearing potential must have a negative serum pregnancy test<br> at Screening and a negative urine pregnancy test on Day 1 prior to first dose of<br> study drug<br><br> - Male and female subjects of childbearing potential who engage in heterosexual<br> intercourse must agree to use protocol specified method(s) of contraception<br><br>Exclusion Criteria:<br><br> - HbA1c = 9.5% at Screening<br><br> - Weight loss > 5% during the 90 days prior to Screening<br><br> - Pregnant or lactating subjects.<br><br> - Current alcohol abuse that is judged by the investigator to potentially interfere<br> with the subject's compliance or safety<br><br> - Current substance abuse that is judged by the investigator to potentially interfere<br> with the subject's compliance or safety<br><br> - A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis<br> B (HBV) surface antigen, or hepatitis C (HCV) antibody<br><br> - Medical history of liver disease other than NAFLD/NASH, including but not limited<br> to, alcoholic liver disease, autoimmune disorders (e.g., primary biliary<br> cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced<br> hepatotoxicity, Wilson disease, clinically significant iron overload, or<br> alpha-1-antitrypsin deficiency.<br><br> - Any history of cirrhosis or decompensated liver disease, including ascites, hepatic<br> encephalopathy, or variceal bleeding, or Child-Pugh-Turcotte score > 6 at Screening<br><br> - Unstable cardiovascular disease<br><br> - History of intestinal resection or malabsorptive condition that may limit the<br> absorption of study drug. Appendectomy and cholecystectomy are not exclusionary.<br><br> - Presence of severe peptic ulcer, gastroesophageal reflux disease, or other gastric<br> acid hypersecretory conditions at Screening, in the opinion of the investigator<br><br> - Any scheduled surgery during the trial period, excluding minor surgical procedures<br> performed under local anesthesia, in the opinion of the investigator<br><br> - History of malignancy within 5 years prior to Screening except adequately treated<br> carcinoma in situ of the cervix, and/or squamous cell cancer, or other localized<br> non-melanoma skin cancer<br><br> - History of significant drug allergy, such as anaphylaxis or significant drug<br> sensitivity, in the opinion of the investigator<br><br> - Known hypersensitivity to study drug, its metabolites, or formulation excipients<br><br> - Presence of any medical condition that could, in the opinion of the investigator,<br> compromise the subject's ability to participate in the study, including a history of<br> substance abuse or a psychiatric disorder, including any subject with a psychiatric<br> hospital admission or emergency room visit in the 2 years prior to Screening<br><br> - Any laboratory abnormality that in the opinion of the investigator could adversely<br> affect the safety of the subject or impair assessment of study results<br><br> - Medications or therapies prescribed or taken over-the-counter for weight loss, in<br> the 90 days prior to Screening<br><br> - Receipt of vaccination for COVID-19 or any other live vaccine within 14 days of<br> planned dosing of study drug<br><br>Note: Other protocol defined Inclusion/Exclusion criteria may apply

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in fasting triglycerides;Incidence of TLC-2716 treatment-emergent adverse events