Viking Therapeutics begins oral VK2735 maintenance trial in obesity
The study will test tablets after 21 weeks of injections in about 195 adults, with weight change tracked through week 33.
Adrian Kessler
A tablet-based test of whether weight loss can be maintained after weekly injections is underway as Viking Therapeutics, Inc. NASDAQVKTX said Tuesday it had begun the second part of its VK2735 maintenance study. The company expects to enrol about 195 adults with obesity and measure their weight through week 33.
The Oct. 6 announcement describes a randomized, blinded comparison of daily or weekly tablets, less frequent injections and placebo after an initial 21 weeks of weekly injected VK2735 or placebo. Its main objectives are safety, tolerability and how the drug moves through the body; weight change is an exploratory measure, so the trial will test a possible maintenance strategy rather than establish that tablets work.
Viking is a San Diego clinical-stage developer of medicines for obesity and metabolic disease. VK2735 is its investigational treatment designed to activate both GLP-1 and GIP receptors.
Viking shares NASDAQVKTX closed at US$29.28 on Nasdaq on Oct. 5, down 2.2 per cent that day, as of 4 p.m. EDT on the linked quote page. That close preceded the trial announcement and does not measure Tuesday's market response.
Tablets Follow An Injection Run-In
After the initial treatment period, participants will switch to daily or weekly oral VK2735, monthly or every-other-week injections, or placebo. The company will compare weight from the starting point and from week 21 to the end of week 33. Tuesday's release gives no oral maintenance efficacy result, p value or safety outcome because this part has just begun.
The study will show whether patients who have already lost weight on weekly injections can keep it off on a tablet schedule. It will also examine whether longer gaps between injections sustain that loss, while the oral arms add a route of dosing the earlier maintenance study did not test.
"We are eager to continue this study with the initiation of Part 2, which will explore multiple regimens, both oral and subcutaneous, with the potential to provide greater optionality and flexibility to best align with a patient's individual weight loss journey," Viking chief executive Brian Lian said in the Oct. 6 release.
On Sept. 22, Viking reported the first part of the injectable maintenance study. After 21 weeks of weekly injections, treated groups had lost about 16 to 19 per cent of body weight. Placebo participants lost about zero per cent, according to the company's readout; Viking reported a p value below 0.0001 against placebo for the treated cohorts.
For the following maintenance period, Viking reported that participants moving to injections every other week retained up to 97 per cent of their earlier weight loss; monthly injections retained up to 90 per cent. The company said gastrointestinal adverse-event rates during maintenance were similar to placebo. Those findings set a benchmark for Part 2, while leaving the oral comparison open.
Phase 3 And Financing Set The Backdrop
Viking's two separate Phase 3 VANQUISH studies are already fully enrolled, according to Tuesday's update. They are testing weekly injected VK2735 against placebo over 78 weeks, including one study in adults without type 2 diabetes and another in adults with it. The July 29 company update says FDA Type C and end-of-Phase-2 feedback preceded those injection trials; Tuesday's maintenance release does not attribute its oral design to FDA advice.
The listed obesity medicine peer set includes Eli Lilly and Company NYSELLY and Novo Nordisk A/S NYSENVO; their company websites cover the category. Viking's Oct. 6 trial adds a test of dosing flexibility to this sector, but it does not compare VK2735 directly against a peer medicine.
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Viking reported a US$502 million cash position at June 30 and closed offerings on Sept. 28 that it estimated would bring US$547.8 million in net proceeds. The company said the financing would support VK2735 development among other uses; its Oct. 6 announcement gives no new cash runway. The cash balance and proceeds represent different dates and should not be added as a current balance.
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Viking plans to begin a separate Phase 3 trial of oral VK2735 in the fourth quarter of 2026, according to its July update. Lian said the Part 2 maintenance results are expected in 2027, when the tablet arms will show whether they can preserve the earlier loss after injections.
