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

This Phase 2a study is designed to evaluate the safety, tolerability, effectiveness, and pharmacokinetics (PK) of TLC-3595 in subjects with insulin resistance.

This is a multicenter, double-blind, randomized study. Participants will be randomized to one of three treatment arms, to receive one of the two doses of TLC-3595 (or matching placebo).

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 confirmed diagnosis of type 2 diabetes mellitus * Screening laboratory evaluations (hematology, chemistry, and urinalysis) must fall within the protocol-defined ranges * A 12-lead electrocardiogram (ECG) at Screening that is normal or with abnormalities that are considered not clinically significant by the investigator * 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 * Male and female subjects of childbearing potential who engage in heterosexual intercourse 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 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 * Unstable cardiovascular disease as defined by any of the following: unstable angina within 6 months prior to Screening; myocardial infarction, coronary artery bypass graft surgery, or coronary angioplasty within 6 months prior to Screening; transient ischemic attack or cerebrovascular accident within 6 months prior to Screening; obstructive valvular heart disease or hypertrophic cardiomyopathy; congestive heart failure (NYHA Class ≥ 2); implanted defibrillator or pacemaker * Medical history of liver disease, 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. A history of nonalcoholic fatty liver disease (NAFLD), including hepatic steatosis or nonalcoholic steatohepatitis (NASH) is permitted. * History of intestinal resection or malabsorptive condition that may limit the absorption of study drug * 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 * Subjects on any oral medication with a narrow therapeutic window (e.g., warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline, and anticonvulsants) * 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 Note: Other protocol defined Inclusion/Exclusion criteria may apply