AzTrials
AzTrials

Insulin ResistancePhase 2NCT05665751

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

A Phase 2 study testing TLC-3595 Dose 1 and TLC-3595 Dose 2 in people with Insulin Resistance, run by OrsoBio, Inc at 4 sites in New Zealand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Insulin Resistance
What is being tested?
TLC-3595 Dose 1 and TLC-3595 Dose 2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
4 sitesNew Zealand
Study dates
8 Mar 2023to Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

New Zealand4 sites

  • OrsoBio Research Site

    Auckland, 0626

  • OrsoBio Reseach Site

    Auckland, 1010

  • OrsoBio Research Site

    Auckland, 1010

  • OrsoBio Research Site

    Christchurch, 8011

Other trials in New Zealand

About this study

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

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

Read the 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).

Being tested
TLC-3595 Dose 1, TLC-3595 Dose 2, Placebo
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TLC-3595 Dose 1Drug

    Tablets administered orally

  • TLC-3595 Dose 2Drug

    Tablets administered orally

  • PlaceboDrug

    Tablets administered orally

Study groups in NCT05665751
Study groupRoleWhat they receive
TLC-3595 Dose 1ExperimentalOral dose of TLC-3595 Dose 1
Receives: Drug: TLC-3595 Dose 1
TLC-3595 Dose 2ExperimentalOral dose of TLC-3595 Dose 2
Receives: Drug: TLC-3595 Dose 2
PlaceboPlacebo comparatorOral dose of placebo-to-match
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in insulin sensitivity

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

    Measured: Through study completion, up to Day 84 of the study

  2. 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.

    Measured: Through study completion, up to Day 84 of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2022
  2. Study start8 Mar 2023
  3. Primary completionSep 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05665751
Sponsor's protocol ID
3595-CL-101
Status last verified
Aug 2024
First submitted
16 Dec 2022
Last updated
20 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TLC-3595 Dose 1 and TLC-3595 Dose 2 in people with Insulin Resistance, run by OrsoBio, Inc at 4 sites in New Zealand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in insulin sensitivity (time frame: Through study completion, up to Day 84 of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05665751.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in