NCT05665751

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

Active, enrolled Phase 2 Last updated 19 August 2024

What this trial tests

Phase 2 trial testing TLC-3595 Dose 1 in Insulin Resistance in 76 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 March 2023

Primary endpoint
1 September 2024

1 December 2024

Quick facts

Lead sponsor	OrsoBio, Inc
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	76
Start date	8 March 2023
Primary completion	1 September 2024
Estimated completion	1 December 2024
Sites	4 locations across New Zealand

Drugs / interventions tested

• TLC-3595 Dose 1 — full drug profile →
• TLC-3595 Dose 2
• Placebo

Conditions studied

• Insulin Resistance — all drugs for Insulin Resistance →

Sponsor

OrsoBio, Inc — full company profile →

Who can join

Adults 18 to 70, any sex, with Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Isotype-selective roles of hepatic acetyl-CoA carboxylases in a mouse model of fatty liver disease.
   Beretta M, Vancuylenburg CS, Shrestha R, Olzomer EM, et al · · 2025 · cited 1× · PMID 41047119 · DOI 10.1016/j.molmet.2025.102264
2. Genetic deletion or pharmacological inhibition of acetyl-CoA carboxylase 2 enhances fatty acid oxidation and improves cardiac function and survival in the murine ATGL knockout model of severe heart failure.
   Usui M, Tsurekawa Y, Ikehara T, Shimazaki A, et al · · 2025 · PMID 40606520 · DOI 10.1016/j.jmccpl.2025.100459