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

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OrsoBio, Inc

Criteria

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

• 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 ≥ 7.5% 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)

• Treatments for insulin resistance or diabetes, including metformin, or medications or therapies for weight loss, in the 90 days prior to Screening

• Contraindications 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