Viking’s Key Obesity Pill Enters Phase 3 Trial – Here’s What Investors Need To Know

• Viking’s Sunrise Phase 3 program includes two studies, Sunrise-1 and Sunrise-2, involving around 1,120 adults.
• Both trials will test daily oral doses of 27.5 mg, 35 mg, and 55 mg against placebo over 68 weeks.
• VK2735 previously delivered up to 12.2% weight loss after 13 weeks in a Phase 2 trial.

Viking Therapeutics (VKTX) took a major step toward competing with obesity drug giants Eli Lilly (LLY) and Novo Nordisk (NVO) on Wednesday, launching two late-stage trials of its key experimental oral weight-loss treatment, VK2735.

The development comes as Viking expands its obesity drugs pipeline to capture a share of the global weight-loss drug market, which Goldman Sachs estimates could reach $114 billion in annual sales by 2030.

VKTX shares edged marginally higher in pre-market trading.

VKTX’s Sunrise Phase 3 Program

Viking’s Sunrise Phase 3 program includes two studies, Sunrise-1 and Sunrise-2, involving around 1,120 adults. Sunrise-1 will evaluate VK2735 in adults with obesity or overweight patients with related health conditions but without type 2 diabetes, whereas Sunrise-2 will focus on patients with type 2 diabetes who are obese or overweight.

Both trials will test daily oral doses of 27.5 mg, 35 mg, and 55 mg against placebo over 68 weeks, primarily measuring changes in body weight. Each study is a randomized, double-blind, placebo-controlled, multicenter trial.

“Oral VK2735 represents the most advanced oral dual GLP-1/GIP agonist in clinical development and has the potential to be positioned as either an induction therapy or in the maintenance setting, increasing the treatment options available to patients and clinicians,” said Brian Lian, CEO of Viking.

Viking’s Phase 2 results showed weight reductions of up to 12.2% after 13 weeks, with no evidence of a weight-loss plateau.

Viking Expands Its Obesity Pipeline

Viking is also developing an injectable version of VK2735, with its two Phase 3 Vanquish trials fully enrolled with 5,500 participants. The company recently launched a separate study exploring longer-term maintenance dosing options, including daily tablets and less frequent injections.

Its broader pipeline includes VK3019, an experimental amylin-based obesity treatment, alongside VK2809 for metabolic and liver diseases and VK0214 for a rare genetic disorder.

Viking reported $502 million in cash, equivalents, and short-term investments as of June 30. In September, the company raised about $548 million through stock and convertible note offerings, primarily to advance and commercialize the VK2735 program and to develop the VK3019 program.

Viking faces pharmaceutical behemoths with blockbuster products, including Eli Lilly’s (LLY) Zepbound and Novo’s (NVO) Wegovy. Both companies have also expanded into pills, with Lilly launching Foundayo in April and Novo introducing an oral Wegovy earlier this year.

Viking hopes its combination of oral and injectable treatments will eventually give patients more flexibility, although VK2735 must still demonstrate its effectiveness and safety in Phase 3 trials before Viking can seek regulatory approval.

Retail’s Take On VKTX

Retail sentiment surrounding VKTX on Stocktwits remained ‘bearish’ over the past 24 hours.

One user highlighted three things that could get VKTX “flying again.”

VKTX shares are down 24% so far this year, underperforming LLY, which is up about 8%, but marginally better off than NVO’s 27% slump.

Also read: Verastem Has Positive Early Cancer Data And $250M In New Funding: What VSTM Investors Need To Know

For updates and corrections, email newsroom[at]stocktwits[dot]com.