Viking Therapeutics二季度更新重申VK2735三期推进但未披露新增临床数据

Conference call scheduled for 4:30 p.m. ET today
-- Phase 3 VANQUISH 1 & 2 Trials for Subcutaneous VK2735 in Obesity Fully Enrolled and Advancing --
-- Oral Phase 3 VK2735 Trial Initiation Expected 4Q26 --
-- VK2735 Maintenance Dosing Data Expected 3Q26 --
-- Phase 1 Study of Amylin Agonist VK3019 Underway --
-- Strong Quarter-End Cash Position of $502 Million --
SAN DIEGO, July 29, 2026 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (Nasdaq: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced its financial results for the second quarter and six months ended June 30, 2026, and provided an update on its clinical pipeline and other corporate developments.
Highlights from the Second Quarter Ended June 30, 2026, and Other Recent Events:
"During the second quarter, we continued to advance each program in our expanding obesity franchise," stated Brian Lian, Ph.D., chief executive officer of Viking. "With respect to our lead compound, VK2735, Viking's Phase 3 VANQUISH-1 and -2 trials are fully enrolled and proceeding according to plan. During the period, the company continued to prepare for initiation of Phase 3 trials with the oral formulation of VK2735, expected to begin in the fourth quarter of this year. Oral VK2735 is positioned to potentially become the first orally available dual GLP-1/GIP agonist to reach the market, potentially offering a competitive advantage compared to GLP-1 mono-agonist oral products currently available. Viking's novel maintenance dosing study also continued to progress. This study is designed to explore the effects of various maintenance regimens, including monthly and every other week dosing, to help us identify and optimize the individualized and long-term care often required to achieve and sustain a healthy weight. We expect to report the results of this study later this quarter. Also during the second quarter, Viking expanded its obesity portfolio with the initiation of a Phase 1 clinical trial of VK3019, an investigational amylin receptor agonist. We are excited to advance this new program into clinical development, which we believe may offer another important potential treatment option to patients living with obesity and overweight. Along with our novel pipeline, we are also carefully expanding our internal infrastructure adding capabilities to maximize the opportunities ahead. To this end, during the quarter, Viking appointed Hubert Chen, M.D., as chief medical officer. Hubert brings more than two decades of leadership experience in senior executive roles spanning drug discovery, clinical development, regulatory strategy, and product approvals across multiple therapeutic areas, including an extensive knowledge of obesity, metabolic disorders, and endocrinology. We are thrilled to have Hubert join the team and we look forward to his many valuable contributions."
Pipeline and Recent Corporate Highlights
Phase 3 VANQUISH 1 & 2 Trials for Subcutaneous VK2735 in Obesity Fully Enrolled and Advancing. VK2735 is a wholly owned long-acting dual agonist of the glucagon like peptide-1, or GLP-1 receptor, and the glucose dependent insulinotropic polypeptide, or GIP receptor, in development for the potential treatment of obesity and other metabolic disorders.
Top-line data from the company's prior Phase 2 VENTURE study of VK2735 in adults with obesity demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7% after 13 weekly doses, with no signs of plateau. Importantly, the VENTURE study also showed VK2735 to be safe and well tolerated through 13 weeks of dosing, with the majority of treatment emergent adverse events characterized as mild or moderate and resolving quickly. These results were highlighted in a presentation at the 2025 ObesityWeek conference last November. The final results were also published in January 2026 in Obesity, the peer-reviewed journal of The Obesity Society.
Following these positive findings, and the receipt of feedback from Viking's Type C and end-of-Phase-2 meetings with the U.S. Food and Drug Administration (FDA), the company advanced subcutaneous VK2735 into Phase 3 development, initiating the VANQUISH Phase 3 registration program in June of last year. The VANQUISH program consists of two clinical trials: one in adults with obesity and one in adults with obesity and type 2 diabetes. Each study is a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks.
Enrollment in each of these trials was rapid, with the VANQUISH-1 study enrolling approximately 4,500 patients by November 2025, approximately five months after trial initiation. Enrollment in the VANQUISH-2 study was completed in the first quarter, enrolling approximately 1,000 patients. Participants in each trial have been randomized to weekly doses of 7.5 mg, 12.5 mg, 17.5 mg, or placebo.
The primary endpoint of the VANQUISH trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures, including the percentage of patients who achieve at least 5%, 10%, 15%, and 20% weight loss. Each study will include an extension portion allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period, including patients who were randomized to placebo for the initial 78-week treatment period.
During the second quarter, both VANQUISH studies continued to proceed according to plan.
Oral Phase 3 VK2735 Trial Initiation Expected 4Q26. In addition to the development of a subcutaneous formulation, Viking is also advancing an oral tablet formulation of VK2735 which, if successful, is positioned to become the first oral dual GLP-1/GIP agonist to reach the market. The company believes the availability of both oral and injectable formulations is a key differentiating feature of VK2735, as no other dual or triple agonist is currently available in both formulations. The availability of both a tablet and a subcutaneous formulation may represent an attractive option for those who prefer to initiate treatment with an oral therapy, or for those seeking to maintain the weight loss they have already achieved with an injectable therapy. Using the same active ingredient across formulations may also reduce the risk of unexpected side effects compared with switching between therapies that do not share the same active agent.
Consistent with Viking's subcutaneous results, the company's prior Phase 1 and Phase 2 studies evaluating oral VK2735 successfully achieved their objectives. In addition to encouraging safety and tolerability, the company's Phase 1 study demonstrated dose-dependent reductions in mean body weight from baseline, ranging up to 8.2% after 28 daily doses.
The Phase 2 VENTURE-oral dosing study of VK2735 also produced positive results. Participants receiving once daily doses of the tablet formulation demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to 12.2% from baseline. Statistically significant differences compared to both baseline and placebo were observed for all doses above 15 mg starting at Week 1 and continuing throughout the 13-week treatment period. Up to 80% of subjects in VK2735 treatment groups achieved at least 10% weight loss after 13 weeks, compared with only 5% of placebo treated subjects.
The tablet formulation of VK2735 also demonstrated encouraging safety and tolerability through 13 weeks of once-daily dosing. The vast majority of drug-related treatment-emergent adverse events were characterized as mild or moderate in severity. Importantly, in the dose range that Viking plans to explore in future studies