Viking Therapeutics has announced the start of a Phase I clinical study to evaluate its dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist VK2735.
The trial, which is investigating healthy adults with a minimum body mass index of 30 kg/m2, will see VK2735 administered as an oral tablet once daily for 28 days. The company hopes for results to be available in the second half of 2023.
The Phase I study is an extension of a previously completed Phase I trial that evaluated the subcutaneous administration of VK2735. In that trial, the drug demonstrated positive signs of clinical activity – all patients receiving VK2735 reported a loss in mean body weight. The company plans to continue studying the subcutaneous formulation in a Phase II study.
Rates of obesity across populations are increasing, and the market for obesity drugs is set to reach $37.1bn across the US, France, Germany, Italy, Spain, UK, and Japan markets, by 2031, according to GlobalData.
GlobalData is the parent company of Pharmaceutical Technology.
Emerging treatment options for obesity and diabetes are indeed proliferating in response to growing demand, but their ability to maintain weight loss will be a key factor in determining their attractiveness for use.
According to Sara Reci, analyst at GlobalData, many late-stage pipeline products for obesity emulate what is currently on the market, and employ the GLP-1 mechanism of action. Activating the GLP-1 receptor is known to reduce appetite and lower body weight. Eli Lilly’s subcutaneously administered tirzepatide, marketed as Mounjaro, is a key market driver and is expected to capture market share with its successful clinical data. Tirzepatide is also a dual GIP receptor and GLP-1 receptor agonist. The FDA had granted the drug a Fast Track designation to the drug to tackle obesity.
Other competitors include Novo Nordisk’s semaglutide, marketed as Wegovy for chronic weight management. Due to high demand, supply chain issues plagued access to Wegovy, with many physicians prescribing another version of semaglutide that is also produced by Novo Nordisk, Ozempic, on an off label basis. Ozempic is currently approved for glycemic control in type 2 diabetes. Additionally, Eli Lilly is also developing orforglipron, purported to be the first triple-agonist therapy.
Following the announcement, Brian Lian, Ph.D, CEO of Viking said, “We believe our novel tablet formulation represents a significant expansion of the programme’s overall potential.”
“In vivo data to date suggests therapeutic plasma levels of VK2735 may be achieved via oral dosing. The ability to select either subcutaneous or oral dosage forms of VK2735 creates attractive potential treatment options,” he added.