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VKTX Completes Enrollment in First Late-Stage Study on Obesity Drug

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Key Takeaways

  • VKTX finished enrollment of about 4,650 adults in the phase III VANQUISH-1 study of obesity drug VK2735.
  • The study tests three weekly SC doses versus placebo, tracking body-weight change after 78 weeks.
  • Rapid recruitment follows earlier full enrollment of the phase II VENTURE-Oral Dosing study this year.

Viking Therapeutics (VKTX - Free Report) announced that it has completed enrolling study participants in the phase III VANQUISH-1 study, which is evaluating the safety and efficacy of the subcutaneous (SC) formulation of its investigational obesity drug, VK2735.

This study has enrolled about 4,650 adults who are either obese or overweight and have at least one weight-related co-morbid condition. These patients have been randomized to one of three dosing arms (7.5 mg, 12.5 mg and 17.5 mg) of the drug or placebo, all of which require weekly administration. The study’s primary endpoint is the percent change in body weight from baseline after 78 weeks of treatment.

The announcement marks a milestone for Viking Therapeutics since the study initiation was declared in June. The number of patients enrolled in the study also crossed the company’s initial target of around 4,500 patients.

Another Enrollment Win for VKTX’s Obesity Program

This is not the first time this year that Viking has completed a recruitment milestone in record time. Earlier this year, the company completed enrollment in the phase II VENTURE-Oral Dosing study that evaluated the oral formulation of VK2735. This study, which was announced in January, reached full enrollment by March.

Viking Therapeutics is also currently enrolling patients in the ongoing phase III VANQUISH-2 study, which was initiated alongside the VANQUISH-1 study. This study will enrol nearly 1,100 obese or overweight adults with type II diabetes. The company expects to complete enrollment in the VANQUISH-2 study in the first quarter of 2026.

Such rapid enrollments suggest strong demand and interest around both the oral and SC versions of VK2735. This aligns with the market expansion for weight loss drugs fueled by the success of Eli Lilly’s (LLY - Free Report) Zepbound and Novo Nordisk’s (NVO - Free Report) Wegovy. The quick recruitment also indicates high patient and physician enthusiasm, which could translate into significant commercial potential if the drug proves effective and safe.

The initiation of the VANQUISH studies is supported by data from the mid-stage VENTURE study, which showed that patients who received the once-weekly VK2735 lost up to 14.7% of their body weight after 13 weeks.

Data from both VANQUISH studies are not expected until 2027.

VKTX Stock’s Performance

Year to date, the company’s shares have lost 10% against the industry’s 17% growth.

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Stiff Competition in the Obesity Space

The obesity market has garnered much interest lately, as both Lilly and Novo Nordisk dominate this space with their respective obesity drugs. According to research conducted by Goldman Sachs, the obesity market in the United States is expected to reach $100 billion by 2030. This is also evident from the fact that LLY and NVO have not only optimized their production capacities but are also developing more potent and convenient GLP-1-based candidates in their clinical pipeline.

NVO and LLY are racing to introduce oral weight-loss pills. Novo Nordisk has already submitted a regulatory filing with the FDA seeking approval for an oral version of Wegovy, with a final decision expected before this year’s end. NVO is also developing several next-generation candidates in its obesity pipeline, including CagriSema (a combination of semaglutide and cagrilintide) and an oral pill, amycretin (a dual GLP-1 and amylin receptor agonist).

Lilly is investing broadly in obesity and has several new molecules currently in clinical development with a range of oral and injectable medications with different mechanisms of action. This includes two late-stage candidates, orforglipron, a once-daily oral GLP-1 small molecule, and retatrutide, a GGG tri-agonist, and some mid-stage candidates, bimagrumab, eloralintide and mazdutide. The company plans to file regulatory applications for orforglipron in obesity later this year, setting up the timeline for a potential launch next year.

Others like Pfizer (PFE - Free Report) , Merck and AbbVie are also looking to enter the obesity space by in-licensing obesity candidates and/or acquiring smaller biotechs, which could threaten Novo Nordisk and Eli Lilly’s dominance.

Last week, Pfizer closed the acquisition of obesity drug developer Metsera for around $10 billion, after a heated bidding war against Novo Nordisk. The Metsera acquisition has brought Pfizer back into the lucrative obesity space by adding the latter’s four novel clinical-stage incretin and amylin programs, which are expected to generate billions of dollars in peak sales.

Both AbbVie and Merck entered this space through a similar route — a licensing deal. While AbbVie forayed into the obesity space earlier this year after signing a licensing agreement with Denmark-based biotech Gubra for the latter’s experimental obesity drug, Merck secured a licensing deal for an investigational oral weight-loss drug developed by China-based Hansoh Pharma last December.

VKTX’s Zacks Rank

Viking Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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