Viking Therapeutics initiates VANQUISH phase 3 obesity clinical programme with GLP-1/GIP agonist VK2735

Overview

Viking Therapeutics, Inc. (Viking), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, announced the initiation of the VANQUISH phase 3 clinical programme for 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 VANQUISH phase 3 trial

• The VANQUISH phase 3 programme includes two studies evaluating VK2735: one in adults with obesity and one in obese or overweight adults with 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.  
• The VANQUISH-1 study will target enrollment of approximately 4500 adults who are obese (BMI =30 kg/m2) or who are overweight (BMI =27 kg/m2) with at least one weight-related co-morbid condition.
• The VANQUISH-2 study will target enrollment of approximately 1,100 adults with type 2 diabetes who are obese or overweight.  
• Participants in both trials will be randomized to one of four weekly treatment arms: VK2735 7.5 mg, VK2735 12.5 mg, VK2735 17.5 mg, and placebo.

The outcomes: 1ry & 2ry endpoints

• The primary endpoint of the 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 =5%, =10%, =15% and =20% body weight reduction.  
• Each study will include an open-label extension allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period.

Statement from the Brian Lian: CEO, Viking

• We are excited to advance VK2735 into phase 3 clinical development, moving one step closer to potentially bringing this important therapeutic to patients with obesity,"" said Brian Lian, Ph.D., chief executive officer of Viking.  
• Along with the successful initiation of the phase 3 programme we continue to make progress on VK2735's broader development.  This includes our plans to initiate an additional clinical study to evaluate a monthly maintenance regimen, which is expected to begin later this year.  We also continue to build on the encouraging early data reported for the oral tablet formulation of VK2735 and expect to report the results of the phase 2 VENTURE-Oral Dosing study in the second half of this year.

Viking’s VK2735 Demonstrates Robust Weight Loss Results in Phase 2 VENTURE Trial

• In 2024, Viking announced positive top-line results from the Phase 2 VENTURE study evaluating subcutaneous VK2735 for the treatment of obesity.
• The trial met its primary and all secondary endpoints, demonstrating clinically meaningful reductions in body weight compared to placebo.
• After 13 weekly doses, patients receiving VK2735 showed:
• Mean body weight reductions of up to 14.7% from baseline
• Placebo-adjusted reductions of up to 13.1%
• Statistically significant differences from placebo were observed from Week 1 onward and persisted throughout the study.
• Follow-up visits conducted four and seven weeks after the final dose revealed that patients maintained the majority of their weight loss, highlighting the durability of VK2735’s effect.

VK2735 safety parameters in VENTURE study

• 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. 
• Of gastrointestinal (GI) related AEs, 95% were reported as mild or moderate.  
• Across all cohorts in the VENTURE study, GI-related AEs were most prevalent during the first week of treatment, with observed rates generally declining through the remainder of the study.

Advancing Metabolic Therapies: GLP-1 and Dual Receptor Agonists

• GLP-1 receptor activation has been shown to:
- Lower blood glucose levels
- Suppress appetite
- Promote weight loss
- Improve insulin sensitivity in patients with type 2 diabetes, obesity, or both.

• Semaglutide, a GLP-1 receptor agonist, is FDA-approved and marketed under:
- Ozempic (injectable)
- Rybelsus (oral)
- Wegovy (higher-dose for obesity)

• Recent research has focused on dual receptor targeting, exploring GIP (glucose-dependent insulinotropic peptide) receptor co-activation to enhance therapeutic outcomes.
• Tirzepatide, a dual GLP-1/GIP receptor agonist, has also received FDA approval and is marketed as:

- Mounjaro (for type 2 diabetes)
- Zepbound (for chronic weight management)
These advancements reflect a paradigm shift in metabolic disease treatment, offering enhanced efficacy through multi-hormonal approaches.

About the company: 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.

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