The trial will enrol nearly 60 adult subjects with BMI of ≥27kg/m² and ≤45kg/m². Credit: Kamil Macniak / Shutterstock.com.

Regor Therapeutics has commenced a Phase II clinical trial for its oral glucagon-like peptide-1 (GLP-1) agonist, RGT-075, designed for adults with obesity or overweight with weight-linked comorbidities.

The announcement is in line with the trial’s ‘First Patient First Visit’ (FPFV) milestone.

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This study aims to assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of RGT-075 versus a placebo.

The randomised, multicentre, double-blind, placebo-controlled trial will involve nearly 60 adult subjects.

These individuals should have a body mass index (BMI) of ≥27kg/m² and ≤45kg/m² to be part of the trial. They will be randomised to receive either a once-a-day oral dose of RGT-075 or a placebo.

The 12-week treatment regimen will begin with a six-week titration period, followed by six weeks at the target dose.

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Regor anticipates reporting topline data for this Phase II  in the second half of this year.

A once-daily, orally available small molecule GLP-1 receptor (GLP1R) full agonist, RGT-075 was discovered and developed by Regor to treat metabolic ailments such as type-2 diabetes mellitus and obesity.

The company concluded Phase I single ascending dose (SAD) and multiple ascending dose (MAD) studies of RGT-075, where it demonstrated safety and was well-tolerated.

Established in 2018, Regor uses its Computer Accelerated Rational Discovery (rCARD) platform for drug development.

It has concluded eight proof of concept candidates (PCCs) in-house and submitted five investigational new drug (IND) applications expediting the discovery of novel therapeutic agents.

Regor’s pipeline includes products in metabolism, oncology, and auto-immunity.

In addition to RGT-075, the assets include RGT-419B, being developed to treat refractory estrogen receptor positive / human epidermal growth factor receptor 2 negative (ER+/HER2) breast cancer patients.

Regor Therapeutics metabolic diseases head Michael Grimm said: “The initiation of the Phase II trial marks an important milestone in the development of RGT-075 as we believe it could represent a convenient and potentially meaningful alternative to the currently available weight loss treatments.

“RGT-075 is designed to be administered orally once daily as a monotherapy or as part of a potential oral combination treatment for obesity. Phase I clinical data showed promising exploratory body weight trends despite short treatment duration.”