We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Viking Therapeutics Starts Phase III Development of Obesity Pill
Read MoreHide Full Article
Key Takeaways
Viking initiated two phase III trials of oral VK2735 in adults with obesity, with and without T2D.
Phase II results showed up to 12.2% mean weight loss at the highest dose versus 1.3% with placebo.
VKTX is expanding its obesity pipeline with injectable VK2735 studies, oral maintenance research and VK3019.
Viking Therapeutics (VKTX - Free Report) 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 - Free Report) 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.
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 - Free Report) . 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.
View the Zacks #1 Rank List
Image: Bigstock
Viking Therapeutics Starts Phase III Development of Obesity Pill
Key Takeaways
Viking Therapeutics (VKTX - Free Report) 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 - Free Report) 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 - Free Report) . 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.