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

Primary Purpose

Insulin Resistance

Status
Recruiting
Phase
Phase 2
Locations
New Zealand
Study Type
Interventional
Intervention
TLC-3595 Dose 1
TLC-3595 Dose 2
Placebo
Sponsored by
OrsoBio, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ≥ 8% 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 Receipt of vaccination for COVID-19 or any other live vaccine within 14 days of planned dosing of study drug Note: Other protocol defined Inclusion/Exclusion criteria may apply

Sites / Locations

  • OrsoBio Research SiteRecruiting
  • OrsoBio Research SiteRecruiting
  • OrsoBio Research SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

TLC-3595 Dose 1

TLC-3595 Dose 2

Placebo

Arm Description

Oral dose of TLC-3595 Dose 1

Oral dose of TLC-3595 Dose 2

Oral dose of placebo-to-match

Outcomes

Primary Outcome Measures

Change in insulin sensitivity
Oral glucose tolerance test will be used to measure insulin sensitivity.
Incidence of TLC-3595 treatment-emergent adverse events
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.

Secondary Outcome Measures

Full Information

First Posted
December 16, 2022
Last Updated
July 17, 2023
Sponsor
OrsoBio, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05665751
Brief Title
A Study Evaluating Daily Oral Doses of TLC-3595 in Participants With Insulin Resistance
Official Title
A Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of TLC-3595 in Subjects With Insulin Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OrsoBio, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TLC-3595 Dose 1
Arm Type
Experimental
Arm Description
Oral dose of TLC-3595 Dose 1
Arm Title
TLC-3595 Dose 2
Arm Type
Experimental
Arm Description
Oral dose of TLC-3595 Dose 2
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral dose of placebo-to-match
Intervention Type
Drug
Intervention Name(s)
TLC-3595 Dose 1
Intervention Description
Tablets administered orally
Intervention Type
Drug
Intervention Name(s)
TLC-3595 Dose 2
Intervention Description
Tablets administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets administered orally
Primary Outcome Measure Information:
Title
Change in insulin sensitivity
Description
Oral glucose tolerance test will be used to measure insulin sensitivity.
Time Frame
Through study completion, up to Day 84 of the study
Title
Incidence of TLC-3595 treatment-emergent adverse events
Description
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.
Time Frame
Through study completion, up to Day 84 of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 ≥ 8% 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 Receipt of vaccination for COVID-19 or any other live vaccine within 14 days of planned dosing of study drug Note: Other protocol defined Inclusion/Exclusion criteria may apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Huss, MD
Phone
650-382-2225
Email
Clinicaltrials_Inquires@orsobio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
OrsoBio Study Director
Organizational Affiliation
OrsoBio, Inc
Official's Role
Study Director
Facility Information:
Facility Name
OrsoBio Research Site
City
Auckland
ZIP/Postal Code
0626
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
OrsoBio Research Site
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
OrsoBio Research Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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