Viking Therapeutics announced Tuesday that its GLP-1/GIP receptor dual agonist helped patients lose up to nearly 15% of their weight over about three months in a Phase II study.
Pictured: Doctor measures waistline of obese patient/iStock, peakSTOCK
Viking Therapeutics on Tuesday posted topline data from the Phase II VENTURE study, demonstrating that its investigational GLP-1/GIP receptor agonist VK2735 can induce significant weight loss in overweight or obese adults.
After 13 weeks of treatment, VK2735 showed a strong dose-dependent benefit on weight control. Patients who were treated with the 2.5-mg dose experienced a 9.1% drop in body weight, compared to only 1.7% in the placebo group. The effect strengthened with increasing treatment dose, reaching 14.7% weight loss at the highest 15-mg dose level.
Compared with placebo, all doses of VK2735 elicited highly statistically significant weight loss at 13 weeks, with all p-values less than 0.0001, according to Viking.
In addition, a significantly higher proportion of VK2735-treated patients achieved at least 10% weight loss versus placebo. At the highest dose level, 88% of patients met this threshold versus just 4% in the placebo group.
In terms of safety, most of the drug-related treatment-emergent adverse events were deemed to be mild. Gastrointestinal side effects were likewise mostly mild or moderate, as cases generally arose early in the treatment course and decreased in frequency following repeated drug exposure. Discontinuations were broadly comparable across the different VK2735 dose groups and placebo.
One patient treated with VK2735 experienced dehydration classified as a serious adverse event and was linked to the study drug.
“Robust weight loss compared with placebo was observed early across all doses evaluated in the VENTURE study, and continued throughout the treatment period in all treatment groups,” Viking CEO Brian Lian said in a statement, adding that weight loss has yet to plateau after 13 weeks for any dose level of VK2735.
The trend suggests that “further weight loss might be achieved from extended dosing periods,” Lian said. Viking is planning to advance VK2735 into further clinical development later this year will meet with the FDA to discuss its next steps.
Viking joins a growing number of biopharma companies seeking to cash in on the highly lucrative obesity market, which some analysts anticipate to reach up to $150 billion to $200 billion in the coming years. The space is currently dominated by Novo Nordisk, which sells Wegovy (semaglutide), and Eli Lilly, which owns Zepbound (tirzepatide), but several other industry heavy-hitters are working on their own candidates.
Boehringer Ingelheim is developing the GLP-1/glucagon receptor dual agonist survodutide, which is currently in five Phase III trials, including SYNCHRONIZE-1, SYNCHRONIZE-2 and SYNCHRONIZE-CVOT, which the company launched in May 2023.
Regeneron is advancing muscle-preserving antibodies trevogrumab and garetosmab, which are designed to improve the quality of weight loss when given together with the current top-selling obesity treatments.
Last week, Indian pharma companies also indicated that they want a slice of the obesity market. Some are developing their own novel therapies and will have to go through clinical trials, while others are taking a generics approach.
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.
