Viking Therapeutics VKTX announced that it has initiated the phase III SUNRISE program to evaluate the oral formulation of its investigational obesity drug VK2735.
The program consists of two phase III studies. The SUNRISE-1 study will enroll obese or overweight adults without type II diabetes (T2D) who have at least one weight-related comorbidity, while the SUNRISE-2 study will enroll obese or overweight adults with T2D.
Viking is targeting an enrolment of 560 adults in each study. These participants will be randomized to either one of the three dosing arms of once-daily VK2735 (27.5 mg, 35 mg, 55 mg) or placebo.
The study’s primary endpoint is the percent change in body weight after 68 weeks of treatment with oral VK2735 versus placebo. Secondary and exploratory endpoints will assess additional safety and efficacy details, including the proportion of participants who lose at least 5%, 10%, 15% or 20% of their body weight.
The initiation of the SUNRISE program is supported by positive results from the phase II VENTURE-Oral study, which evaluated once-daily VK2735 oral for 13 weeks. The study met its primary and secondary endpoints. Participants receiving the highest dose achieved a mean body weight reduction of up to 12.2% compared with 1.3% in the placebo group.
VKTX Stock’s Performance
Despite the positive update, shares of Viking were down 4.4% on Wednesday.
Year to date, the stock has lost 27.6% compared with the industry’s 0.3% decline.
Image Source: Zacks Investment Research
New Initiation Expands Viking’s Obesity Pipeline
VK2735, VKTX’s most advanced candidate, is designed to target both GLP-1 and GIP receptors. This dual action has already demonstrated efficacy with Eli Lilly’s LLY tirzepatide, which is marketed as Zepbound for obesity and Mounjaro for T2D. Tirzepatide has demonstrated substantial weight loss and improved blood sugar control.
In addition to the oral formulation, Viking is developing a subcutaneous (SC) formulation of VK2735, administered by injection. This version is being evaluated across two phase III studies in adults with obesity or overweight, with and without T2D. The company has already completed enrolment in both studies.
In September, Viking reported encouraging results from the first part of its VK2735 maintenance study, which showed that participants preserved most of their weight loss from the induction phase even when dosing frequency was materially reduced. Data showed that while participants who moved to every-other-week dosing maintained an average of 90% of their earlier weight loss, while those who switched to monthly dosing maintained an average of 85%.
Building on these results, Viking recently initiated the second part of its maintenance study to evaluate oral VK2735 as a potential option for maintaining weight loss. The study will assess whether weight loss achieved with weekly VK2735 SC can be maintained using oral tablets or less frequent injections. An update on this study is expected next year.
Alongside announcing the initiation of the SUNRISE program, Viking clarified a dosing detail in its oral maintenance study. An earlier announcement had incorrectly referred to “weekly oral doses,” whereas the oral maintenance arm will evaluate daily oral dosing. This distinction is important as the company explores the potential for oral VK2735 to complement its injectable formulation and offer greater flexibility for long-term weight management.
Viking is also broadening its obesity pipeline beyond VK2735. In June, the company initiated a phase I study of VK3019, an investigational dual amylin and calcitonin receptor agonist. Management believes therapies targeting these receptors could be used alone or in combination with GLP-1 or dual GLP-1/GIP agonists to improve weight-loss induction and support longer-term weight management.
Intensifying Competition in the Obesity Space
Advancing oral VK2735 into phase III development further expands Viking’s obesity pipeline as competition intensifies in a market dominated by pharma giants Eli Lilly and Novo Nordisk NVO. Both companies are already market 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 as drugmakers develop next-generation combination therapies. 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 Wegovy with cagrilintide, a long-acting amylin receptor agonist. A final decision is expected before this year’s end.
Viking Therapeutics, Inc. Price
Viking Therapeutics, Inc. price | Viking Therapeutics, Inc. Quote
VKTX’s Zacks Rank
Viking Therapeutics currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks' Research Chief Names "Stock Most Likely to Double"
Our team of experts has just released the 5 stocks with the greatest probability of gaining +100% or more in the coming months. Of those 5, Director of Research Sheraz Mian highlights the one stock set to climb highest.
This innovative software-as-a-service firm upped its user base +22% year over year. That rate is increasing and margins are expanding as AI efficiencies take effect. Of course, all our elite picks aren't winners, but this one could far surpass earlier Zacks' Stocks Set to Double like D-Wave Quantum, which shot up +680.1%.
Free: See Our Top Stock And 4 Runners UpWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Viking Therapeutics, Inc. (VKTX): Free Stock Analysis Report
Novo Nordisk A/S (NVO): Free Stock Analysis Report
Eli Lilly and Company (LLY): Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).