A Study Evaluating Daily Oral Doses of TLC-3595 in Participants With Insulin Resistance

Inclusion Criteria:

• Male or female between 18-70 years of age, inclusive, at Screening

• BMI ≥ 28 kg/m2 at Screening

• Diagnosis of insulin resistance based on HOMA-IR > 2.84 at Screening or a confirmeddiagnosis of type 2 diabetes mellitus

• Screening laboratory evaluations (hematology, chemistry, and urinalysis) must fallwithin the protocol-defined ranges

• 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 > 10% at Screening

• Weight loss > 5% weight 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

• Unstable cardiovascular disease as defined by any of the following: unstable anginawithin 6 months prior to Screening; myocardial infarction, coronary artery bypassgraft surgery, or coronary angioplasty within 6 months prior to Screening; transientischemic attack or cerebrovascular accident within 6 months prior to Screening;obstructive valvular heart disease or hypertrophic cardiomyopathy; congestive heartfailure (NYHA Class ≥ 2); implanted defibrillator or pacemaker

• Medical history of liver disease, including but not limited to, alcoholic liverdisease, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosingcholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease,clinically significant iron overload, or alpha-1-antitrypsin deficiency. A historyof nonalcoholic fatty liver disease (NAFLD), including hepatic steatosis ornonalcoholic steatohepatitis (NASH) is permitted.

• History of intestinal resection or malabsorptive condition that may limit theabsorption of study drug

• 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

• Subjects on any oral medication with a narrow therapeutic window (e.g., warfarin,digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline, andanticonvulsants)

• 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