Viking Therapeutics Announces Completion of Enrollment in Phase 3 VANQUISH-1 Trial of VK2735

Rhea-AI Summary

Viking Therapeutics (NASDAQ: VKTX) announced on November 19, 2025 that enrollment is complete in the Phase 3 VANQUISH-1 trial of subcutaneous VK2735 ahead of schedule and above target. The randomized, double-blind, placebo-controlled trial enrolled ~4,650 adults with obesity or overweight plus comorbidity, randomized to VK2735 7.5 mg, 12.5 mg, 17.5 mg, or placebo. The study will evaluate percent change in body weight at 78 weeks as the primary endpoint and includes secondary/exploratory responder endpoints (≥5%, ≥10%, ≥15%, ≥20% weight loss) plus a 52-week extension. Viking said VANQUISH-2 (type 2 diabetes with obesity) is enrolling and expects enrollment completion in Q1 2026. Prior Phase 2 VENTURE showed up to 14.7% mean weight reduction after 13 weekly doses with generally mild-to-moderate adverse events.

Positive

• Enrollment complete for VANQUISH-1 at ~4,650 participants
• Enrollment finished ahead of schedule and above target
• Phase 2 VENTURE showed up to 14.7% mean weight reduction

Negative

• Primary endpoint assessed at 78 weeks, extending time to topline results
• Large Phase 3 safety and efficacy readouts still pending despite Phase 2 success

Insights

Clinical development strategist

Completion of VANQUISH-1 enrollment early and above target materially advances VK2735 Phase 3 development.

Enrollment of approximately 4,650 adults in a randomized, double‑blind, placebo‑controlled Phase 3 that runs 78 weeks signals operational execution and strong patient demand for subcutaneous VK2735. A four‑arm dosing design (7.5 mg, 12.5 mg, 17.5 mg, placebo) preserves the ability to compare dose responses and to evaluate both primary percent change in body weight at week 78 and secondary categorical endpoints (achieving 5, 10, 15, 20 weight reductions).

Key dependencies and risks include final data on the primary endpoint at week 78 and the safety profile over the extended 52‑week extension; prior Phase 2 VENTURE showed up to 14.7 mean weight reduction after 13 weeks and mostly mild‑to‑moderate AEs, which is supportive but not determinative for Phase 3 outcomes. Watch for topline efficacy and detailed safety disclosures at the end of the primary period and any imbalance in discontinuations or serious adverse events; expect initial topline readouts after the last subject completes the 78-week dosing window and any subsequent extension analyses in the months that follow.

78-Week Study Evaluating Subcutaneous VK2735 in Adults with Obesity

Enrollment Completed Ahead of Schedule and Above Target Size, Indicating Strong Interest in VK2735

SAN DIEGO, Nov. 19, 2025 /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 the completion of patient enrollment in its Phase 3 VANQUISH-1 clinical trial of subcutaneous VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.  VK2375 is being developed in both oral and subcutaneous formulations for the potential treatment of metabolic disorders such as obesity.

The Phase 3 VANQUISH-1 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.  The trial enrolled approximately 4,650 adults with obesity (BMI ≥30 kg/m²) or who are overweight (BMI ≥27 kg/m²) with at least one weight-related co-morbid condition.  Enrolled patients have been randomized to one of four weekly treatment arms: VK2735 7.5 mg, 12.5 mg, 17.5 mg, and placebo. 

The primary endpoint of the trial 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 are evaluating a range of additional safety and efficacy measures, including the percentage of patients who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction.  The study includes a 52-week extension period allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period.

"We are excited to announce completion of enrollment in VANQUISH-1 ahead of schedule," said Brian Lian, Ph.D., chief executive officer of Viking.  "As with prior VK2735 studies, the trial accrued rapidly and exceeded our enrollment target.  We believe this speaks to the enthusiasm for new obesity treatments beyond those currently available.  We look forward to completing enrollment in the VANQUISH-2 study in the first quarter of 2026."

Concurrently, Viking is conducting the Phase 3 VANQUISH-2 study of subcutaneous VK2735 in patients with type 2 diabetes who have obesity or are overweight.  That trial is currently enrolling patients, and the company expects to complete enrollment in the first quarter of 2026.

In 2024, Viking announced positive results from the Phase 2 VENTURE study of VK2735 in obesity.  This trial successfully achieved its primary and secondary endpoints, with subjects receiving VK2735 demonstrating statistically significant reductions in body weight compared with placebo.  After 13 weekly subcutaneous doses, subjects receiving VK2735 demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7% with no signs of plateau.  VK2735 also demonstrated encouraging safety and tolerability in the VENTURE study, with the majority of observed adverse events (AEs) being reported as mild or moderate.  Treatment and study discontinuation rates among VK2735 cohorts were well-balanced compared with placebo.

About GLP-1 and Dual GLP-1/GIP Agonists

Activation of the glucagon-like peptide 1 (GLP-1) receptor has been shown to decrease glucose, reduce appetite, lower body weight, and improve insulin sensitivity in patients with type 2 diabetes, obesity, or both. Semaglutide is a GLP-1 receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Ozempic^®, Rybelsus^®, and Wegovy^®. More recently, research efforts have explored the potential co-activation of the glucose-dependent insulinotropic peptide (GIP) receptor as a means of enhancing the therapeutic benefits of GLP-1 receptor activation. Tirzepatide is a dual GLP-1/GIP receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Mounjaro^® and Zepbound^®.

About Viking Therapeutics, Inc.

Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with two programs currently in clinical trials. Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. Viking's clinical programs include VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. Data from a Phase 1 and a Phase 2 trial evaluating VK2735 (dosed subcutaneously) for metabolic disorders demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. Concurrently, the company is evaluating an oral formulation of VK2735 in a Phase 2 trial. Viking is also developing VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders. The compound successfully achieved both the primary and secondary endpoints in a recently completed Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. In a Phase 2a trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. The company's newest program is evaluating a series of internally developed dual amylin and calcitonin receptor agonists (or DACRAs) for the treatment of obesity and other metabolic disorders.  In the rare disease space, Viking is developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the potential treatment of X-linked adrenoleukodystrophy (X-ALD).  In a Phase 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of X-ALD, VK0214 was shown to be safe and well-tolerated, while driving significant reductions in plasma levels of very long-chain fatty acids (VLCFAs) and other lipids, as compared to placebo.

For more information about Viking Therapeutics, please visit www.vikingtherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its clinical and preclinical development programs, anticipated timing for reporting clinical data and cash resources.  Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance.  These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials, including those for VK2735, VK0214, VK2809, and the company's other incretin receptor agonists; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; and other risks that are described in Viking's most recent periodic reports filed with the Securities and Exchange Commission including Viking's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings.  These forward-looking statements speak only as of the date hereof.  Viking disclaims any obligation to update these forward-looking statements except as required by law.

View original content to download multimedia:https://www.prnewswire.com/news-releases/viking-therapeutics-announces-completion-of-enrollment-in-phase-3-vanquish-1-trial-of-vk2735-302619296.html

SOURCE Viking Therapeutics, Inc.

FAQ

How many patients did Viking enroll in the VANQUISH-1 Phase 3 trial (VKTX) and when was enrollment completed?

VANQUISH-1 enrolled approximately 4,650 patients and enrollment was completed on November 19, 2025.

What doses of subcutaneous VK2735 are being tested in VANQUISH-1 (VKTX)?

Patients were randomized to weekly subcutaneous VK2735 at 7.5 mg, 12.5 mg, 17.5 mg, or placebo.

What is the primary endpoint and treatment duration for VANQUISH-1 (VKTX)?

The primary endpoint is percent change in body weight from baseline versus placebo after 78 weeks of treatment.

When does Viking expect to finish enrollment for the VANQUISH-2 Phase 3 trial (VKTX)?

Viking expects to complete enrollment in VANQUISH-2 in the first quarter of 2026.

What were the Phase 2 VENTURE results for VK2735 cited by Viking (VKTX)?

VENTURE demonstrated statistically significant weight reductions versus placebo, with mean reductions up to 14.7% after 13 weekly subcutaneous doses.