VKTX Initiates Phase 3 Study on Obesity Candidate VK2735

Viking Therapeutics VKTX announced that it has initiated the phase III VANQUISH program, evaluating the subcutaneous (SC) formulation of its experimental obesity drug VK2735 in adult patients with or without type II diabetes.

The VANQUISH clinical program will consist of two phase III studies. The VANQUISH-1 study will enroll obese adults with at least one weight-related co-morbid condition, while the VANQUISH-2 study will enroll obese or overweight adults with type II diabetes. These patients have been randomized to one of the four dosing arms of VK2735 or placebo.

Each study will investigate the safety and efficacy of once weekly VK2735 SC for 78 weeks.

The study’s primary endpoint is the percent change in body weight from baseline after 78 weeks of treatment with VK2735 as compared to a placebo. The secondary and exploratory endpoints of the study will check other safety and efficacy details, including how many people lose 5%, 10%, 15%, or 20% or more body weight.

Year to date, shares of Viking have declined 32.6% compared with the industry’s decrease of 2.7%.

VKTX's Ongoing Development Activities Related to VK2735

The VANQUISH clinical program is supported by data from the phase II VENTURE study, which evaluated once-weekly VK2735 SC for 13 weeks. The study met its primary and all secondary endpoints with statistical significance. Treatment with the SC version achieved statistically significant reductions in mean body weight, ranging up to 14.7%.

Besides the SC formulation of VK2735, the company is also developing an oral formulation of the drug candidate.

The phase II VENTURE-Oral Dosing study is evaluating the safety and efficacy of the oral formulation of VK2735. Data from this study is expected in the second half of 2025.

VK2735 has shown blockbuster potential, having demonstrated superior weight reduction capabilities in clinical studies, both as an SC injection and an oral pill.

VK2735 targets both GLP-1 and GIP receptors. This dual action may offer greater weight loss, better blood sugar control, and fewer side effects.

Stiff Competition in the Obesity Space

Competition in the obesity market is intensifying. The market is expected to expand to $100 billion by 2030, according to data from Goldman Sachs. Eli Lilly LLY and Novo Nordisk NVO presently dominate the market with their GLP-1 drugs.

Lilly markets Mounjaro for type II diabetes and Zepbound for obesity, and Novo Nordisk markets Ozempic (pre-filled pen) for type II diabetes and Wegovy (injection) for obesity.

Both LLY and NVO are currently investing heavily to optimize their production capacities and have started evaluating multiple other novel obesity candidates.

Drug giant, Amgen AMGN, is making rapid progress in the development of GLP-1-based candidates in its clinical pipeline.

Amgen has initiated a broad phase III program on its dual GIPR/GLP-1 receptor agonist, MariTide, across obesity, obesity-related conditions and type II diabetes, with the first two phase III studies commencing in March.

AMGN plans to launch additional phase III studies on MariTide in specific obesity-related conditions throughout 2025.

Others like Roche, Merck and AbbVie have also entered the obesity space by in-licensing obesity candidates from smaller biotechs.

VKTX's Zacks Rank

Viking Therapeutics currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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