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

Inclusion Criteria:

• BMI ≥ 28 kg/m2 at Screening

• Fasting TG ≥ 350 mg/dL

• Subjects without diabetes or subjects with diabetes and HbA1c < 9.5% at Screening

• Screening laboratory evaluations (eGFR, ALT, AST, INR, total bilirubin, plateletcount) must fall within the protocol-defined ranges

• A clinical diagnosis of NAFLD/NASH within 5 years of Screening based on historicalhepatic imaging (e.g., ultrasound, MRI, computed tomography [CT], or ControlledAttenuation Parameter [CAP] by vibration-controlled transient elastography ≥ 250dB/m), and no documented weight loss > 5% between the date of the historical hepaticimaging and Screening OR a historical liver biopsy within 5 years of Screeningconsistent with NAFLD/NASH without cirrhosis and no documented weight loss > 5%between the date of the historical liver biopsy and Screening

• Normotensive subjects or subjects without uncontrolled hypertension, defined assystolic blood pressure > 155 mmHg and/or diastolic blood pressure > 90 mmHg atScreening

• A 12-lead electrocardiogram (ECG) at Screening that is normal or with abnormalitiesthat are considered not clinically significant by the investigator

• Female subjects of childbearing potential must have a negative serum pregnancy testat Screening and a negative urine pregnancy test on Day 1 prior to first dose ofstudy drug

• Male and female subjects of childbearing potential who engage in heterosexualintercourse must agree to use protocol specified method(s) of contraception

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 interferewith the subject's compliance or safety

• Current substance abuse that is judged by the investigator to potentially interferewith the subject's compliance or safety

• A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitisB (HBV) surface antigen, or hepatitis C (HCV) antibody

• Medical history of liver disease other than NAFLD/NASH, including but not limitedto, alcoholic liver disease, autoimmune disorders (e.g., primary biliarycholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-inducedhepatotoxicity, Wilson disease, clinically significant iron overload, oralpha-1-antitrypsin deficiency.

• Any history of cirrhosis or decompensated liver disease, including ascites, hepaticencephalopathy, or variceal bleeding, or Child-Pugh-Turcotte score > 6 at Screening

• Unstable cardiovascular disease

• History of intestinal resection or malabsorptive condition that may limit theabsorption of study drug. Appendectomy and cholecystectomy are not exclusionary.

• Presence of severe peptic ulcer, gastroesophageal reflux disease, or other gastricacid hypersecretory conditions at Screening, in the opinion of the investigator

• Any scheduled surgery during the trial period, excluding minor surgical proceduresperformed under local anesthesia, in the opinion of the investigator

• History of malignancy within 5 years prior to Screening except adequately treatedcarcinoma in situ of the cervix, and/or squamous cell cancer, or other localizednon-melanoma skin cancer

• History of significant drug allergy, such as anaphylaxis or significant drugsensitivity, 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 ofsubstance abuse or a psychiatric disorder, including any subject with a psychiatrichospital admission or emergency room visit in the 2 years prior to Screening

• Any laboratory abnormality that in the opinion of the investigator could adverselyaffect the safety of the subject or impair assessment of study results

• Medications or therapies prescribed or taken over-the-counter for weight loss, inthe 90 days prior to Screening

• Receipt of vaccination for COVID-19 or any other live vaccine within 14 days ofplanned dosing of study drug

Note: Other protocol defined Inclusion/Exclusion criteria may apply