The early-stage study showed that Viking Therapeutics’ oral obesity candidate VK2735, a dual agonist of the GLP-1 and GIP receptors, elicited a 3.3% reduction in mean body weight. The company plans to start a Phase II trial.
Pictured: White pills on a black background/iStock, Michael Niessen
Viking Therapeutics on Tuesday released promising Phase I data for the oral formulation of its obesity candidate VK2735, demonstrating strong body weight reductions in obese adults.
In the early-stage, multiple ascending dose trial, patients showed dose-dependent decreases in mean body weight versus placebo. In particular, the highest dose level of 40 mg elicited a 3.3% drop in mean body weight relative to placebo, an effect that was statistically significant with a p-value of 0.0006. In this dose group, 57% of participants lost at least 5% of their body weight, versus 0% in the placebo arm.
Patients who were given VK2735 doses of at least 10 mg also saw sustained placebo-adjusted weight-loss, which extended or further improved through 34 days of follow-up, or six days after the last dose of the oral obesity drug was given.
The findings “highlight VK2735’s promising early weight loss and tolerability profile when dosed as an oral tablet,” Viking CEO Brian Lian said in a statement, adding that the company will run a Phase II study for the weight-loss pill in the second half of this year “exploring longer treatment windows and potentially higher doses.”
Viking will also continue further dose escalation in the Phase I trial.
The main goal of the Phase I trial was to evaluate the safety and tolerability of the oral formulation of VK2735. It found that there were no serious adverse events. Most gastrointestinal events were mild or moderate and none of the VK2735-treated patients developed vomiting.
“We are particularly pleased with the initial safety and tolerability data, which suggest a differentiated profile with minimal gastrointestinal-related side effects,” Lian said in a statement. “We believe that an oral agent with good tolerability could represent an attractive potential treatment option for patients with obesity.
VK2735 works via two pathways. Like most obesity medications, the drug candidate activates the GLP-1 receptor, which facilitates the secretion of insulin in response to blood glucose levels. This mechanism of action suppresses appetite to help with weight loss. VK2735 also activates the GIP receptor, which boosts its GLP-1-mediated therapeutic effects.
Viking is also advancing an intravenous formulation of VK2735, which last month aced the Phase II VENTURE study, according to topline data. At 13 weeks, patients treated with a 2.5-mg dose lost 9.1% of their body weight, while placebo counterparts dropped only 1.7% of their body weight. At the highest dose level of 15 mg, weight loss reached 14.7%.
AstraZeneca is also aiming to develop an oral obesity medication. In November 2023, the pharma signed a potential $1.83 billion license agreement with Shanghai-based Eccogene to advance ECC5004, an oral GLP-1 receptor agonist.
Eli Lilly, which owns tirzepatide—one of the two frontrunners in the injectable weight-loss drug market alongside Novo Nordisk’s semaglutide—is also developing an oral obesity therapy called orforglipron. In June 2023, the pharma published Phase II findings in the New England Journal of Medicine showing that orfoglipron can cut 8.6% to 12.6% of body weight through 26 weeks of follow-up.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
