Viking Therapeutics has initiated a Phase II VENTURE clinical trial of VK2735 for the treatment of obesity.

The placebo-controlled, double-blind, randomised study is designed to assess the pharmacokinetics, tolerability, safety, and weight loss efficacy of VK2735 in patients who are obese with BMI ≥30kg/m².

In this trial, nearly 125 adults will receive four different doses of VK2735 subcutaneously once a week for 13 weeks.

Percent change in body weight from baseline to week 13 is the primary endpoint while assessing other safety and efficacy measures are the secondary and exploratory endpoints of the study.

Viking Therapeutics CEO Brian Lian said: “We are excited to announce the initiation of the VENTURE study, which will build upon the promising VK2735 Phase I data we reported earlier this year.

“Obesity is a major healthcare challenge, and recent data confirm that effective weight loss agents can reduce a patient’s cardiovascular risk profile, providing important health benefits.”

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A favourable safety, tolerability, and predictable pharmacokinetic profile of VK2735 was demonstrated in the single ascending dose portion of the Phase I study.

All MAD cohorts receiving VK2735 for 28 days also showed reductions in mean body weight from baseline, ranging up to 7.8%. 

No hypoglycemia was reported in patients while a majority of them showed mild or moderate observed adverse events.

The company also plans to initiate a Phase I trial of oral VK2735 to offer patients an option to choose between subcutaneous and oral dosage forms. Initial data from this trial is expected in the fourth quarter of this year.

A dual agonist VK2735 acts on the glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptors.

These receptors upon activation have been shown to reduce appetite, lower body weight, decrease glucose, and improve insulin sensitivity in patients with type 2 diabetes, obesity, or both.

VK2735 is also in development for treating various metabolic disorders.