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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05665751




Registration number
NCT05665751
Ethics application status
Date submitted
16/12/2022
Date registered
27/12/2022
Date last updated
28/02/2024

Titles & IDs
Public title
A Study Evaluating Daily Oral Doses of TLC-3595 in Participants With Insulin Resistance
Scientific title
A Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of TLC-3595 in Subjects With Insulin Resistance
Secondary ID [1] 0 0
3595-CL-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin Resistance 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TLC-3595 Dose 1
Treatment: Drugs - TLC-3595 Dose 2
Treatment: Drugs - Placebo

Experimental: TLC-3595 Dose 1 - Oral dose of TLC-3595 Dose 1

Experimental: TLC-3595 Dose 2 - Oral dose of TLC-3595 Dose 2

Placebo Comparator: Placebo - Oral dose of placebo-to-match


Treatment: Drugs: TLC-3595 Dose 1
Tablets administered orally

Treatment: Drugs: TLC-3595 Dose 2
Tablets administered orally

Treatment: Drugs: Placebo
Tablets administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in insulin sensitivity
Timepoint [1] 0 0
Through study completion, up to Day 84 of the study
Primary outcome [2] 0 0
Incidence of TLC-3595 treatment-emergent adverse events
Timepoint [2] 0 0
Through study completion, up to Day 84 of the study

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2024
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
OrsoBio, Inc
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05665751
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
OrsoBio Study Director
Address 0 0
OrsoBio, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ryan Huss, MD
Address 0 0
Country 0 0
Phone 0 0
650-382-2225
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05665751