Viking Therapeutics Completes Enrollment in VK2735 Maintenance Dosing Clinical Trial for Obesity
Viking Therapeutics, Inc. (NASDAQ: VKTX), a clinical-stage biopharmaceutical company specializing in therapies for metabolic and endocrine disorders, has announced the successful completion of patient enrollment in its maintenance dosing study for VK2735. This dual agonist targets the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors and is designed to evaluate various dosing regimens following initial weight loss.
Key Details of the VK2735 Clinical Trial
The maintenance dosing study is a Phase 1, randomized, double-blind, placebo-controlled trial that included approximately 180 adults with a body mass index (BMI) of ≥30 kg/m². Participants were initially administered weekly subcutaneous doses of VK2735 or a placebo for a 19-week period.
Post Week 19, they will transition to different maintenance dosing regimens, which include:
- Weekly subcutaneous dosing
- Every other week subcutaneous dosing
- Monthly subcutaneous dosing
- Daily oral dosing
- Weekly oral dosing
- Placebo
The study’s objectives are to evaluate the safety, tolerability, and pharmacokinetic profile of VK2735 under these varied regimens. Additionally, it aims to assess changes in body weight from baseline and during the final assessment at Week 31.
Significance of the VK2735 Dosing Regimens
Dr. Brian Lian, CEO of Viking Therapeutics, emphasized the importance of developing effective maintenance dosing regimens for long-term weight loss benefits. "The successful development of maintenance dosing regimens is critical to realizing the long-term health benefits from weight loss and may provide an opportunity to further differentiate VK2735 from currently available obesity treatments," he stated.
He also highlighted the potential advantages of using the same dual-acting GLP-1/GIP agonist molecule for both subcutaneous and oral formulations, as this could offer enhanced treatment flexibility with VK2735.
Other Ongoing Studies Involving VK2735
In addition to the maintenance dosing trial, Viking Therapeutics is conducting two Phase 3 studies, known as VANQUISH-1 and VANQUISH-2, which are also evaluating the efficacy and safety of subcutaneous VK2735. The VANQUISH-1 trial has enrolled approximately 4,650 adults with obesity, while VANQUISH-2 aims to enroll around 1,100 adults with type 2 diabetes.
Both studies feature a randomized controlled design where participants will receive doses of VK2735 at three different strengths (7.5 mg, 12.5 mg, and 17.5 mg) or a placebo, administered weekly for a total of 78 weeks.
Understanding GLP-1 and Dual GLP-1/GIP Agonists
GLP-1 receptor activation has proven effective in lowering glucose, reducing appetite, and improving insulin sensitivity in patients suffering from type 2 diabetes or obesity. Approved therapies such as Semaglutide are already utilized extensively under various brand names, including Ozempic® and Wegovy®.
Recent studies have begun to explore dual agonism, combining GLP-1 with GIP receptor activation, which has shown promise in enhancing therapeutic outcomes. Tirzepatide is an example of a dual agonist already on the market.
About Viking Therapeutics, Inc.
Viking Therapeutics, Inc. is dedicated to developing first-in-class therapies targeting metabolic and endocrine disorders, leveraging its metabolism expertise. The company is advancing clinical programs, including VK2735, and is pursuing innovative candidates such as VK2809 for lipid and metabolic disorders.
As Viking Therapeutics progresses with its clinical trials, stakeholders can track updates on the VKTX symbol for potential investment insight and developments.
Forward-Looking Statements
This article includes forward-looking statements that relate to Viking Therapeutics' expectations concerning its clinical development programs and potential market dynamics. These statements involve significant risks and uncertainties that could lead to different outcomes than anticipated. It is advised that readers consider these risks and refer to Viking's official reports for detailed insights.