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

Exclusion Criteria

• •HbA1c ≥ 9.5% at Screening
• •Weight loss \> 5% during the 90 days prior to Screening
• •Pregnant or lactating subjects.
• •Current alcohol abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety
• •Current substance abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety
• •A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen, or hepatitis C (HCV) antibody
• •Medical history of liver disease other than NAFLD/NASH, 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.
• •Any history of cirrhosis or decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding, or Child-Pugh-Turcotte score \> 6 at Screening
• •Unstable cardiovascular disease
• •History of intestinal resection or malabsorptive condition that may limit the absorption of study drug. Appendectomy and cholecystectomy are not exclusionary.
• •Presence of severe peptic ulcer, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions at Screening, in the opinion of the investigator
• •Any scheduled surgery during the trial period, excluding minor surgical procedures performed under local anesthesia, in the opinion of the investigator
• •History of malignancy within 5 years prior to Screening except adequately treated carcinoma in situ of the cervix, and/or squamous cell cancer, or other localized non-melanoma skin cancer
• •History of significant drug allergy, such as anaphylaxis or significant drug sensitivity, in the opinion of the investigator
• •Known hypersensitivity to study drug, its metabolites, or formulation excipients
• •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
• •Any laboratory abnormality that in the opinion of the investigator could adversely affect the safety of the subject or impair assessment of study results
• •Medications or therapies prescribed or taken over-the-counter for weight loss, in the 90 days prior to Screening
• •Receipt of vaccination for COVID-19 or any other live vaccine within 14 days of planned dosing of study drug