US-based biotechnology company, NGM Bio, has begun the Phase I trial of NGM313, an agonistic antibody, in overweight or obese people.
NGM313 is a humanised monoclonal antibody designed to treat type 2 diabetes, obesity and nonalcoholic steatohepatitis (NASH).
It is designed to selectively activate the beta-klotho (KLB)-FGFR1c receptor complex and promote beneficial metabolic activity.
The randomised, double-blind, placebo-controlled Phase I trial is designed to evaluate the safety, tolerability and pharmacokinetic effect of NGM313 after being administered in single and multiple ascending doses.
The trial will also evaluate different biomarkers related to metabolic regulation and the results are expected to be reported next year.
NGM Bio vice-president chief medical officer Alex DePaoli said: "This first-in-human trial represents a significant step towards establishing the profile of NGM313, which we hope will be an important new medicine for the treatment of metabolic diseases.
"The identification of this novel therapeutic also highlights the capabilities of NGM Bio’s research team, who engineered a potent and highly selective antibody that represents an innovative approach to modulating the activity of this pathway."
NGM313 specifically activates the KLB-FGFR1c receptor complex, which is responsible for the regulation of body weight, triglycerides and cholesterol, as well as insulin sensitivity and the uptake of glucose in various tissues.
According to the company, NGM313 can result to loss of body weight and improved insulin sensitivity through a mechanism that is complementary to existing type 2 diabetes treatments that promote insulin production or secretion.
Under a collaboration agreement executed last year with NGM Bio, Merck has an exclusive, one-time option to license NGM313 following completion of a human proof of concept trial.