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

This is a Phase 2a, multicenter, double-blind, randomized study designed to evaluate the safety, tolerability, effectiveness, and pharmacokinetics of TLC-3595 activity in participants with insulin resistance.

Inclusion Criteria:Male or female between 18-70 years of age, inclusive, at ScreeningBMI ≥ 28 kg/m2 at ScreeningDiagnosis of insulin resistance based on HOMA-IR > 2.84 at ScreeningScreening laboratory evaluations (hematology, chemistry, and urinalysis) must fall within the protocol-defined rangesA 12-lead electrocardiogram (ECG) at Screening that is normal or with abnormalities that are considered not clinically significant by the investigatorFemale 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 drugMale and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraceptionExclusion Criteria:HbA1c ≥ 7.5% at ScreeningWeight loss > 5% weight during the 90 days prior to ScreeningPregnant or lactating subjects.Current alcohol abuse that is judged by the investigator to potentially interfere with the subject's compliance or safetyCurrent substance abuse that is judged by the investigator to potentially interfere with the subject's compliance or safetyA positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen, or hepatitis C (HCV) antibodyUnstable 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 pacemakerMedical 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 drugPresence of severe peptic ulcer, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions at Screening, in the opinion of the investigatorAny scheduled surgery during the trial period, excluding minor surgical procedures performed under local anesthesia, in the opinion of the investigatorHistory 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 cancerHistory of significant drug allergy, such as anaphylaxis or significant drug sensitivity, in the opinion of the investigatorKnown hypersensitivity to study drug, its metabolites, or formulation excipientsPresence 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 ScreeningAny laboratory abnormality that in the opinion of the investigator could adversely affect the safety of the subject or impair assessment of study resultsSubjects on any oral medication with a narrow therapeutic window (e.g., warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline, and anticonvulsants)Treatments for insulin resistance or diabetes, including metformin, or medications or therapies for weight loss, in the 90 days prior to ScreeningContraindications or inability to complete MRI scanning (e.g., presence of permanent pacemakers, implanted cardiac devices, claustrophobia, weight restrictions, etc.)Receipt of vaccination for COVID-19 or any other live vaccine within 14 days of planned dosing of study drug