Viking Therapeutics Announces Initiation of VK2735 Oral Phase 3 Clinical Program in Patients with Obesity

Viking launches two major Phase 3 trials for oral obesity drug VK2735.

What the company is saying

Viking Therapeutics is announcing the initiation of the SUNRISE Phase 3 clinical program for oral VK2735, targeting obesity and type 2 diabetes. The company frames VK2735 as a dual GLP-1/GIP agonist and emphasizes its potential as both an induction and maintenance therapy, highlighting convenience and flexibility for patients. CEO Brian Lian, Ph.D., is quoted to reinforce confidence in the oral formulation’s advancement and its potential to expand treatment options. The announcement stresses the positive Phase 2 results—up to 12.2% mean body weight reduction after 13 weeks and high rates of patients achieving at least 5% (97%) and 10% (80%) weight loss compared to placebo (10% and 5%, respectively). Safety is addressed by noting that 98% of drug-related adverse events were mild or moderate, with gastrointestinal events being most common and generally subsiding. The company also mentions ongoing and fully enrolled Phase 3 trials for the subcutaneous formulation (VANQUISH-1 and VANQUISH-2), as well as additional pipeline assets. The tone is confident and forward-looking, with the narrative built around clinical progress and differentiation in the obesity treatment landscape.

What the data suggests

The SUNRISE Phase 3 program consists of two randomized, double-blind, placebo-controlled trials, each enrolling 560 adults for 68 weeks of once-daily oral VK2735 at 27.5 mg, 35 mg, 55 mg, or placebo. The primary endpoint is percent change in body weight from baseline, with secondary endpoints tracking the proportion of patients achieving at least 5%, 10%, 15%, or 20% weight loss. In the prior Phase 2 VENTURE-Oral study, patients achieved up to 12.2% mean body weight reduction after 13 weeks, with 97% reaching at least 5% weight loss and 80% reaching at least 10%, compared to 10% and 5% for placebo. Safety data show 98% of drug-related adverse events were mild or moderate, and gastrointestinal events were most common but generally resolved with continued dosing. The subcutaneous VK2735 Phase 3 VANQUISH-1 trial is fully enrolled with about 4,500 adults without type 2 diabetes, and VANQUISH-2 is fully enrolled with about 1,000 adults with type 2 diabetes. Both subcutaneous trials use weekly dosing over 78 weeks. The figures indicate robust prior efficacy and safety, but no Phase 3 data are yet available, so the commercial and clinical impact remains unproven.

Analysis

The announcement is upbeat, emphasizing the initiation of two Phase 3 trials for oral VK2735 and referencing strong Phase 2 results. The narrative highlights the potential of VK2735 as both induction and maintenance therapy, but these are forward-looking statements not yet supported by Phase 3 data. While the Phase 2 efficacy and safety results are specific and credible, the main news is the start of lengthy (68-week) Phase 3 trials, meaning any commercial or clinical benefit is at least 1.5 years away. There is no mention of large capital outlays or immediate financial impact, and no financial metrics are disclosed. The tone is optimistic but proportionate to the milestone; however, the forward-looking language about future clinical and commercial positioning slightly inflates the signal relative to the current stage. The data supports operational progress, but the true value remains unproven until Phase 3 results are available.

Risk flags

• ●Phase 3 efficacy and safety remain unproven for oral VK2735; strong Phase 2 results do not guarantee Phase 3 success, and failure to replicate efficacy or safety would undermine the program’s value.
• ●The timeline to value is long, with at least 16 months before SUNRISE Phase 3 data, exposing the company to clinical, regulatory, and market risks over an extended period.
• ●The obesity drug market is highly competitive, with established GLP-1 and dual agonist therapies already approved and marketed; VK2735’s differentiation and market uptake are not yet demonstrated.
• ●Operational risk exists in enrolling and retaining 560 patients per SUNRISE trial over 68 weeks, as well as maintaining adherence and data integrity across multiple sites.
• ●No financial data or cash runway figures are disclosed, so the company’s ability to fund these lengthy trials through completion is not addressed.

Bottom line

Viking Therapeutics is moving its oral VK2735 obesity drug into two large, pivotal Phase 3 trials, following strong Phase 2 results showing up to 12.2% mean weight loss and high responder rates. The company’s subcutaneous formulation is also in fully enrolled Phase 3 studies, but all programs require lengthy treatment and follow-up, with no commercial or regulatory catalysts expected for at least 16 months. While the Phase 2 data are promising, the true clinical and commercial value will only be established if Phase 3 efficacy and safety are confirmed. The absence of financial disclosures leaves open questions about funding and operational runway. The most important takeaway is that Viking’s obesity franchise is advancing on multiple fronts, but investors must wait for long-term data before any value can be realized.

Announcement summary

(NASDAQ:VKTX) Viking Therapeutics, Inc. announced the initiation of the SUNRISE Phase 3 clinical program for oral VK2735, a dual agonist of the GLP-1 and GIP receptors, for the treatment of obesity and type 2 diabetes. The SUNRISE program consists of two randomized, double-blind, placebo-controlled, multicenter trials: SUNRISE-1, enrolling obese or overweight adults without type 2 diabetes but with at least one weight-related comorbidity, and SUNRISE-2, enrolling obese or overweight adults with type 2 diabetes. Each study will enroll 560 adults, with participants randomized to receive once-daily oral VK2735 at doses of 27.5 mg, 35 mg, 55 mg, or placebo for 68 weeks. The primary endpoint for both trials is the percent change in body weight from baseline after 68 weeks, with secondary and exploratory endpoints including the percentage of patients achieving at least 5%, 10%, 15%, or 20% body weight reduction. Brian Lian, Ph.D., chief executive officer of Viking, stated that advancing oral VK2735 into Phase 3 is an important step for the company's obesity portfolio and highlighted the potential for oral VK2735 to be used as induction or maintenance therapy. In 2025, Viking reported positive top-line results from the Phase 2 VENTURE-Oral Dosing study, where patients receiving once-daily oral VK2735 achieved up to 12.2% mean body weight reduction from baseline after 13 weeks, with statistically significant differences versus placebo for all doses greater than 15 mg starting at Week 1. Up to 97% of patients on VK2735 achieved at least 5% weight loss, and up to 80% achieved at least 10% weight loss, compared to 10% and 5% of placebo patients, respectively. Safety data from Phase 2 showed that 98% of drug-related treatment-emergent adverse events were mild or moderate, with gastrointestinal events being the most common and generally subsiding with continued dosing. Progressive dose escalation in 30 mg increments allowed rapid advancement to higher doses while maintaining tolerability. Viking is also conducting a maintenance dosing trial of oral VK2735 and two Phase 3 studies (VANQUISH-1 and VANQUISH-2) evaluating subcutaneous VK2735. VANQUISH-1 is fully enrolled with approximately 4,500 adults without type 2 diabetes who are obese or overweight with at least one weight-related comorbidity, and VANQUISH-2 is fully enrolled with approximately 1,000 adults with type 2 diabetes who are obese or overweight. Both VANQUISH trials randomize patients to weekly subcutaneous VK2735 doses of 7.5 mg, 12.5 mg, 17.5 mg, or placebo for 78 weeks. A correction note clarified that the oral VK2735 maintenance dosing trial evaluates daily oral, monthly subcutaneous, every-other-week subcutaneous, or placebo dosing, not weekly oral doses as previously stated. Viking is also advancing additional obesity and metabolic disease programs, including VK3019, VK2809, and VK0214.

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