VKTX Advances Obesity Program With New Oral Maintenance Study
Viking Therapeutics VKTX announced the initiation of a clinical study evaluating oral maintenance dosing of its lead obesity candidate, VK2735.
The study, which is designed to enroll approximately 195 adults with obesity, will evaluate whether weight loss achieved with weekly subcutaneous (SC) VK2735 can be maintained using oral tablets or less frequent injections.
All participants will initially receive weekly SC VK2735 or placebo for 21 weeks. After the induction period, patients who received the drug will transition to different maintenance regimens, including daily or weekly oral doses of VK2735, monthly or every-other-week subcutaneous VK2735 or placebo. The study will evaluate safety, tolerability and pharmacokinetics, while exploratory measures will assess changes in body weight through week 33.
The oral formulation could provide an important convenience advantage if it successfully maintains weight loss. A data readout from this study is expected in 2027.
Year to date, the company’s shares have lost 19.4% against the industry’s 3.6% growth.
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Earlier Results Support Maintenance Potential for VKTX
Viking’s newly launched study is the second part of its two-part weight-maintenance program, expanding VK2735 beyond weekly injections. The initiation of part 2 follows encouraging results from part 1 of the maintenance study announced last month. During the 21-week induction phase, patients receiving weekly SC VK2735 achieved approximately 16% to 19% weight loss compared with a 0.1% decline for placebo.
Notably, much of the weight loss was maintained after a reduction in injection frequency. Patients switched to every-other-week dosing retained about 90% of their previous weight loss, while those receiving monthly dosing retained roughly 85%. By comparison, patients switched to placebo retained about 61% of their prior weight loss.
These findings suggest that VK2735 may have potential not only as a weight-loss treatment but also as a maintenance therapy that could reduce dosing frequency after initial weight loss is achieved.
VK2735 Remains the Key Pipeline Driver for VKTX
VK2735 is the company's lead obesity candidate and primary value driver. It is an investigational novel dual GLP-1 and GIP receptor agonist, being developed in both subcutaneous and oral formulations, positioning it as one of the more promising late-stage obesity therapies currently under development.
The company is conducting two late-stage studies — VANQUISH-1 and VANQUISH-2 — evaluating VK2735 SC for 78 weeks. VANQUISH-1 is evaluating the drug in adults without type II diabetes (T2D) who have obesity or are overweight with at least one weight-related co-morbid condition. VANQUISH-2 is assessing its efficacy in obese or overweight adults with T2D. Data from these studies are not expected before 2027.
Both studies are testing weekly doses of 7.5 mg, 12.5 mg and 17.5 mg against placebo. The phase III program is expected to provide important data on the long-term efficacy and safety of VK2735 in different patient populations.
Viking is on track to start late-stage studies of oral VK2735 by the end of this year, following encouraging phase II VENTURE-Oral results.
Competition in Targeted Markets Remains a Concern
Viking is developing the candidate as a potential alternative to established GLP-1 products marketed by pharma giants Eli Lilly LLY and Novo Nordisk NVO. Both companies are already marketing oral and injectable obesity treatments. Lilly markets injectable Zepbound and oral Foundayo, while Novo Nordisk markets injectable Wegovy and its oral Wegovy pill.
The competitive landscape is also evolving rapidly. Lilly recently reported results for EloraTZP, an investigational combination of eloralintide, a selective amylin receptor agonist and Zepbound. Data from a phase IIb study showed that all EloraTZP combinations met the primary and secondary endpoints, delivering substantial weight loss and A1C reductions at 48 weeks. LLY plans to advance the candidate into phase III development in the fourth quarter of 2026.
Meanwhile, Novo Nordisk has submitted CagriSema to the FDA for weight management. The once-weekly treatment combines semaglutide with cagrilintide, a long-acting amylin receptor agonist. A final decision is expected before this year’s end.
VKTX's Zacks Rank
Viking currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
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This article originally published on Zacks Investment Research (zacks.com).
