OrsoBio has dosed the first participant in a Phase IIa clinical trial of selective acetyl-CoA carboxylase 2 (ACC2) inhibitor, TLC-3595.
The double-blind, multicentre, placebo-controlled, randomised trial will assess the efficacy, safety, and tolerability of two TLC-3595 doses in insulin resistant patients.
It will also assess the insulin sensitising effects of TLC-3595, alone and along with approved diabetes therapies in the indicated patients.
In the trial, 50 insulin resistant overweight or obese patients, including those with type 2 diabetes on glucose lowering therapies will be enrolled.
Improvement in insulin sensitivity based on data from an oral glucose tolerance test (OGTT) after therapy for four weeks is the primary endpoint of the trial.
Biomarkers of glycemic control (e.g., HbA1c, glucose, glycated albumin), lipids, MRI/magnetic resonance spectroscopy (MRS) based assessments of muscle and liver fat, key drivers of insulin resistance, and fatty acid oxidation (FAO) are the additional exploratory endpoints of the trial.
OrsoBio chief medical officer Rob Myers said: “With the growing global burden of type 2 diabetes, the need for novel, well tolerated therapies that enhance insulin sensitivity has never been greater.
“Dosing our first patient in this Phase IIa trial is an important milestone for OrsoBio as we continue to advance our four programs to address unmet needs in patients with severe metabolic disorders, including diabetes, obesity, nonalcoholic steatohepatitis (NASH), and dyslipidemias.”
Proof-of-concept data supporting TLC-3595’s efficacy and safety are expected by the end of this year.
According to OrsoBio, 537 million adults are living with diabetes currently. This is estimated to increase to more than 640 million by 2030 and nearly 780 million by 2045.
