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

NCT ID: NCT05665751

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-08
• Study Completion Date: 2024-12-31

Brief Summary

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

Detailed Description

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).

Conditions

Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TLC-3595 Dose 1

Oral dose of TLC-3595 Dose 1

Group Type: EXPERIMENTAL

TLC-3595 Dose 1

Intervention Type: DRUG

Tablets administered orally

TLC-3595 Dose 2

Oral dose of TLC-3595 Dose 2

Group Type: EXPERIMENTAL

TLC-3595 Dose 2

Intervention Type: DRUG

Tablets administered orally

Placebo

Oral dose of placebo-to-match

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets administered orally

Interventions

TLC-3595 Dose 1

Tablets administered orally

Intervention Type: DRUG

TLC-3595 Dose 2

Tablets administered orally

Intervention Type: DRUG

Placebo

Tablets administered orally

Intervention Type: DRUG

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OrsoBio, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

OrsoBio Study Director

Role: STUDY_DIRECTOR

OrsoBio, Inc

Locations

OrsoBio Research Site

Auckland, , New Zealand

OrsoBio Reseach Site

Auckland, , New Zealand

OrsoBio Research Site

Auckland, , New Zealand

OrsoBio Research Site

Christchurch, , New Zealand

Countries

New Zealand

Other Identifiers

3595-CL-101

Identifier Type: -

Identifier Source: org_study_id