Viking's Oral VK2735 Enters Phase 3: SUNRISE Program Initiated Oct 14, 2026
Viking Therapeutics (NASDAQ: VKTX) announced on Oct. 14, 2026 the initiation of the SUNRISE Phase 3 clinical program for oral VK2735, its dual GLP-1/GIP receptor agonist — delivering on the Q4 2026 commitment and making Viking the first independent challenger to run both an oral and an injectable obesity asset through Phase 3 registration simultaneously.
Program design (per the press release): two randomized, double-blind, placebo-controlled 68-week trials — SUNRISE-1 (obese BMI≥30 or overweight BMI≥27 adults without T2D, ~560 participants) and SUNRISE-2 (obese/overweight adults with T2D, ~560) — testing once-daily oral VK2735 at 27.5 mg, 35 mg, 55 mg vs placebo, primary endpoint percent change in body weight at 68 weeks.
CEO Brian Lian positioned the asset against the incumbents' pills: "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." He also emphasized flexibility: oral VK2735 "together with our subcutaneous formulation, which is currently in the Phase 3 VANQUISH registration program, could provide clinicians and patients with greater choice."
Evidence base: SUNRISE is supported by the Phase 2 VENTURE-Oral study — dose-dependent mean weight loss up to 12.2% at just 13 weeks with no plateau, up to 97% of treated patients achieving ≥5% and 80% achieving ≥10% loss (vs 10%/5% on placebo), and 98% of drug-related TEAEs mild/moderate. The subcutaneous formulation's VANQUISH-1 (~4,500 adults) and VANQUISH-2 (~1,000 T2D adults) trials are fully enrolled, dosing weekly for 78 weeks.
Also this month: Viking initiated Part 2 of its oral maintenance dosing study (Oct. 6) — testing daily oral, monthly subcutaneous, and every-other-week subcutaneous dosing vs placebo — after issuing a correction clarifying the original release wrongly said "weekly oral doses." Solving maintenance/adherence is the differentiator Viking is building its case around (see GLP-1s Reposition as Lifestyle Drugs: Novo Markets "Customers," Not "Patients" — "Live Lighter" and "Summer Glow Up" for the adherence-driven positioning war among incumbents).
Investor take: With Oral GLP-1 Race Goes Global: Foundayo Wins EU CHMP Backing; Lilly's Oct 29 Q3 Print Is the Next Catalyst showing Lilly and Novo absorbing the first wave of oral demand, Viking's oral + subQ pairing is the most advanced duopoly-external threat; Phase 3 data (VANQUISH expected first) is the value driver, and the stock sold off modestly (-2.4%) on the initiation news per MarketScreener — the market wanted the subQ readout, not more trial starts.