Viking Therapeutics Announces Initiation of VK2735 Maintenance Dosing Clinical Trial in Patients with Obesity

Rhea-AI Summary

Viking Therapeutics (NASDAQ: VKTX) initiated a Phase 1 randomized, double-blind, placebo-controlled maintenance dosing study of VK2735 in approximately 180 adults with obesity on Oct 21, 2025. All participants receive initial weekly subcutaneous VK2735 or placebo for 19 weeks, then transition to maintenance arms: monthly subcutaneous, weekly oral, daily oral, or placebo through Week 31.

The study will evaluate safety, tolerability, and pharmacokinetics, with exploratory endpoints including change in body weight from baseline and from Week 19 to Week 31. Viking expects to report results in 2026. Viking is also conducting two Phase 3 weekly subcutaneous trials: VANQUISH-1 (~4,500) and VANQUISH-2 (~1,100), each dosed for 78 weeks.

Positive

• Initiated Phase 1 maintenance trial in ~180 adults with obesity
• Study tests multiple maintenance routes: monthly subcutaneous, weekly oral, daily oral
• All participants receive 19 weeks of weekly subcutaneous dosing before maintenance
• Concurrent Phase 3 programs: VANQUISH-1 ~4,500 and VANQUISH-2 ~1,100 (78 weeks)

Negative

• Phase 1 sample size (~180) limits definitive efficacy conclusions
• Primary objectives are safety/tolerability/PK; weight endpoints are exploratory
• Results not expected until 2026, extending timeline for actionable data

Study to Explore Maintenance Dosing Regimens Following Initial Weight Loss with VK2735

Monthly Subcutaneous, Weekly Oral, and Daily Oral Regimens to be Evaluated

SAN DIEGO, Oct. 21, 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 initiation of an exploratory maintenance dosing study of 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 various metabolic disorders such as obesity.  The trial being announced today is intended to explore the feasibility of various VK2735 maintenance dosing regimens utilizing either the oral tablet or the subcutaneous formulation to sustain the initial weight loss achieved following weekly subcutaneous dosing.

The maintenance dosing study is a Phase 1, randomized, double-blind, placebo-controlled trial in approximately 180 adults with obesity (BMI ≥30 kg/m²) and otherwise healthy.  All participants will receive initial weekly subcutaneous doses of VK2735 or placebo for 19 weeks.  Following Week 19, participants will be transitioned to a range of VK2735 maintenance dosing options including monthly subcutaneous doses, daily oral doses, weekly oral doses, or placebo.  The objectives of the study are to evaluate the safety, tolerability, and pharmacokinetic profile of VK2735 under these various dosing regimens.  Exploratory endpoints will assess change in body weight from baseline, as well as change in body weight from Week 19 to the end of the study at Week 31.

"This study will provide key information to help identify future VK2735 maintenance regimens," said Brian Lian, Ph.D., chief executive officer of Viking.  "Flexible dosing options including potential weekly or monthly subcutaneous administration, as well as potential daily or weekly oral administration, are important differentiating features of our program that could facilitate improved treatment persistence.  Adherence to therapy increases the probability of realizing the long-term benefits of weight loss such as reduced cardiovascular risks, improved physical function and increased quality of life.  We look forward to reporting the results from this study in 2026."

In addition to the maintenance dosing study, Viking is currently conducting two Phase 3 studies evaluating subcutaneous VK2735 (VANQUISH-1 and VANQUISH-2).  These trials are randomized, double-blind, placebo-controlled, multicenter trials designed to assess the efficacy and safety of subcutaneous VK2735 dosed weekly for 78 weeks.  The VANQUISH-1 study is targeting enrollment of approximately 4,500 adults who do not have type 2 diabetes and who have obesity (BMI ≥30 kg/m²) or are overweight (BMI ≥27 kg/m²) with at least one weight-related co-morbid condition.  The VANQUISH-2 study is targeting enrollment of approximately 1,100 adults with type 2 diabetes who have obesity or are overweight.  Patients in both trials are being randomized to one of four weekly treatment arms: VK2735 7.5 mg; VK2735 12.5 mg; VK2735 17.5 mg; and 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 three compounds 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.

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SOURCE Viking Therapeutics, Inc.

FAQ

What is the design of Viking's VK2735 Phase 1 maintenance dosing trial (VKTX)?

A randomized, double-blind, placebo-controlled Phase 1 trial in ~180 adults with obesity: 19 weeks of weekly subcutaneous dosing, then transition to monthly subcutaneous, weekly oral, daily oral, or placebo through Week 31.

When will Viking report results from the VK2735 maintenance dosing study (VKTX)?

Viking expects to report results from the maintenance dosing study in 2026.

What endpoints will the VK2735 maintenance study (VKTX) evaluate?

The study will evaluate safety, tolerability, and pharmacokinetics, with exploratory endpoints for change in body weight from baseline and from Week 19 to Week 31.

How does the VK2735 maintenance study fit with Viking's Phase 3 programs (VKTX)?

The maintenance study explores dosing flexibility after initial weekly dosing while Viking runs two Phase 3 trials: VANQUISH-1 (~4,500) and VANQUISH-2 (~1,100), each dosed weekly for 78 weeks.

What dosing regimens are being tested for VK2735 maintenance (VKTX)?

Maintenance regimens include monthly subcutaneous, weekly oral, daily oral, or placebo following 19 weeks of weekly subcutaneous dosing.