A Study Evaluating Daily Oral Doses of TLC-3595 in Participants With Insulin Resistance
- Conditions
- Insulin Resistance
- Registration Number
- NCT05665751
- Lead Sponsor
- OrsoBio, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Male or female between 18-70 years of age, inclusive, at Screening<br><br> - BMI = 28 kg/m2 at Screening<br><br> - Diagnosis of insulin resistance based on HOMA-IR > 2.84 at Screening or a confirmed<br> diagnosis of type 2 diabetes mellitus<br><br> - Screening laboratory evaluations (hematology, chemistry, and urinalysis) must fall<br> within the protocol-defined ranges<br><br> - A 12-lead electrocardiogram (ECG) at Screening that is normal or with abnormalities<br> that are considered not clinically significant by the investigator<br><br> - Female subjects of childbearing potential must have a negative serum pregnancy test<br> at Screening and a negative urine pregnancy test on Day 1 prior to first dose of<br> study drug<br><br> - Male and female subjects of childbearing potential who engage in heterosexual<br> intercourse must agree to use protocol specified method(s) of contraception<br><br>Exclusion Criteria:<br><br> - HbA1c > 10% at Screening<br><br> - Weight loss > 5% weight during the 90 days prior to Screening<br><br> - Pregnant or lactating subjects.<br><br> - Current alcohol abuse that is judged by the investigator to potentially interfere<br> with the subject's compliance or safety<br><br> - Current substance abuse that is judged by the investigator to potentially interfere<br> with the subject's compliance or safety<br><br> - A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis<br> B (HBV) surface antigen, or hepatitis C (HCV) antibody<br><br> - Unstable cardiovascular disease as defined by any of the following: unstable angina<br> within 6 months prior to Screening; myocardial infarction, coronary artery bypass<br> graft surgery, or coronary angioplasty within 6 months prior to Screening; transient<br> ischemic attack or cerebrovascular accident within 6 months prior to Screening;<br> obstructive valvular heart disease or hypertrophic cardiomyopathy; congestive heart<br> failure (NYHA Class = 2); implanted defibrillator or pacemaker<br><br> - Medical history of liver disease, including but not limited to, alcoholic liver<br> disease, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing<br> cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease,<br> clinically significant iron overload, or alpha-1-antitrypsin deficiency. A history<br> of nonalcoholic fatty liver disease (NAFLD), including hepatic steatosis or<br> nonalcoholic steatohepatitis (NASH) is permitted.<br><br> - History of intestinal resection or malabsorptive condition that may limit the<br> absorption of study drug<br><br> - Presence of severe peptic ulcer, gastroesophageal reflux disease, or other gastric<br> acid hypersecretory conditions at Screening, in the opinion of the investigator<br><br> - Any scheduled surgery during the trial period, excluding minor surgical procedures<br> performed under local anesthesia, in the opinion of the investigator<br><br> - History of malignancy within 5 years prior to Screening except adequately treated<br> carcinoma in situ of the cervix, and/or squamous cell cancer, or other localized<br> non-melanoma skin cancer<br><br> - History of significant drug allergy, such as anaphylaxis or significant drug<br> sensitivity, in the opinion of the investigator<br><br> - Known hypersensitivity to study drug, its metabolites, or formulation excipients<br><br> - Presence of any medical condition that could, in the opinion of the investigator,<br> compromise the subject's ability to participate in the study, including a history of<br> substance abuse or a psychiatric disorder, including any subject with a psychiatric<br> hospital admission or emergency room visit in the 2 years prior to Screening<br><br> - Any laboratory abnormality that in the opinion of the investigator could adversely<br> affect the safety of the subject or impair assessment of study results<br><br> - Subjects on any oral medication with a narrow therapeutic window (e.g., warfarin,<br> digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline, and<br> anticonvulsants)<br><br> - Medications or therapies prescribed or taken over-the-counter for weight loss, in<br> the 90 days prior to Screening.<br><br> - Receipt of vaccination for COVID-19 or any other live vaccine within 14 days of<br> planned dosing of study drug<br><br>Note: Other protocol defined Inclusion/Exclusion criteria may apply
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in insulin sensitivity;Incidence of TLC-3595 treatment-emergent adverse events
- Secondary Outcome Measures
Name Time Method