Viking Therapeutics Launches Phase 3 SUNRISE Program for Once-Daily Oral VK2735 in Obesity

Viking Therapeutics, Inc. (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, announced on October 14, 2026 that it has started the SUNRISE Phase 3 clinical program for the oral tablet formulation of VK2735, its dual agonist of the GLP-1 and GIP receptors. As a result, VK2735 now has two late-stage tracks running at the same time. The tablet joins the subcutaneous formulation, which is already in the Phase 3 VANQUISH registration program.

Two 68-Week Studies Targeting 1,120 Adults

The SUNRISE program consists of two randomized, double-blind, placebo-controlled, multicenter trials, each targeting 560 adults. SUNRISE-1 will enroll adults with obesity (BMI of 30 or higher) or who are overweight (BMI of 27 or higher) with at least one weight-related condition, but without type 2 diabetes. SUNRISE-2, by contrast, will enroll adults with type 2 diabetes who are obese or overweight.

In both studies, participants will take VK2735 once daily for 68 weeks at one of three doses (27.5 mg, 35 mg or 55 mg) or placebo. The primary endpoint is the percent change in body weight from baseline compared with placebo after 68 weeks. Secondary and exploratory endpoints will track the share of patients reaching 5%, 10%, 15% or 20% weight loss, along with additional safety and efficacy measures.

“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,” said Brian Lian, Ph.D., chief executive officer of Viking. He added that a once-daily oral therapy “could offer a flexible dosing option that may support improved treatment adherence over time.”

What the Phase 2 Tablet Data Showed

The Phase 3 design follows the Phase 2 VENTURE-Oral Dosing trial, which enrolled 280 adults with obesity and reported results in August 2025. After 13 weeks, patients taking the tablet showed mean weight loss of up to 12.2% from baseline, or up to 10.9% relative to placebo. In addition, up to 80% of patients on VK2735 reached at least 10% weight loss, compared with 5% on placebo.

On tolerability, Viking reported that 98% of drug-related treatment-emergent adverse events were mild or moderate. Gastrointestinal events were the most common and generally occurred early in treatment. Meanwhile, the company disclosed in its August 2025 results that 20% of participants receiving VK2735 discontinued treatment due to an adverse event, compared with 13% of those on placebo.

Parallel Programs and Funding

SUNRISE adds to an already full late-stage slate. The subcutaneous VANQUISH-1 and VANQUISH-2 trials are fully enrolled with approximately 4,500 and 1,000 adults, respectively, and test weekly injections over 78 weeks. Separately, Viking started Part 2 of a maintenance dosing study on October 6 in approximately 195 adults. According to a correction issued with the SUNRISE announcement, that study will compare daily oral doses, monthly and every-other-week subcutaneous doses, and placebo as ways to maintain weight loss after initial weekly injections.

On the financing side, Viking closed concurrent upsized offerings on September 28, 2026 of 9,035,714 common shares at $35.00 per share and $258.75 million of 2.00% convertible senior notes due 2032, for gross proceeds of approximately $575.0 million. Before that raise, the company reported cash, cash equivalents and short-term investments of $502 million as of June 30, 2026. For the second quarter, it posted a net loss of $128.0 million, with research and development expenses of $115.8 million.

Strategic Investment Summary

• Phase 3 Start: Viking Therapeutics, Inc. (NASDAQ: VKTX) initiated the SUNRISE Phase 3 program for once-daily oral VK2735 in obesity on October 14, 2026.
• Trial Design: SUNRISE-1 and SUNRISE-2 will each target 560 adults, with and without type 2 diabetes, over 68 weeks of treatment.
• Primary Endpoint: Both studies measure percent change in body weight from baseline versus placebo at week 68.
• Phase 2 Basis: The tablet produced mean weight loss of up to 12.2% at 13 weeks in the VENTURE-Oral Dosing trial, with up to 80% of patients reaching 10% weight loss.
• Parallel Programs: The subcutaneous VANQUISH trials are fully enrolled with approximately 5,500 adults combined, and a maintenance dosing study is underway.
• Capital Raised: The company closed approximately $575.0 million in gross proceeds from stock and convertible note offerings on September 28, 2026.

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