Clinical Trials/NCT05665751

NCT05665751

Active, Not Recruiting

Phase 2

A Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of TLC-3595 in Subjects With Insulin Resistance

OrsoBio, Inc2 sites in 1 country76 target enrollmentMarch 8, 2023

ConditionsInsulin Resistance

InterventionsTLC-3595 Dose 1 TLC-3595 Dose 2 Placebo

DrugsTLC-3595 Dose 1 TLC-3595 Dose 2 Placebo

Overview

Phase: Phase 2
Intervention: TLC-3595 Dose 1
Conditions: Insulin Resistance
Sponsor: OrsoBio, Inc
Enrollment: 76
Locations: 2
Primary Endpoint: Change in insulin sensitivity
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 8, 2023

End Date

December 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

OrsoBio, Inc

Responsible Party

Sponsor

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

Arms & Interventions

TLC-3595 Dose 1

Oral dose of TLC-3595 Dose 1

Intervention: TLC-3595 Dose 1

TLC-3595 Dose 2

Oral dose of TLC-3595 Dose 2

Intervention: TLC-3595 Dose 2

Placebo

Oral dose of placebo-to-match

Intervention: Placebo

Outcomes

Primary Outcomes

Change in insulin sensitivity

Time Frame: Through study completion, up to Day 84 of the study

Oral glucose tolerance test will be used to measure insulin sensitivity.

Incidence of TLC-3595 treatment-emergent adverse events

Time Frame: Through study completion, up to Day 84 of the study

Adverse events (AEs) - severity of the AEs will be graded using the Common Terminology Criteria for AE (CTCAE) (v5.0). The relationship between AEs and the study drug will be indicated as related or not related.