Viking Therapeutics Starts Phase 2 VENTURE Trial of VK2735 Tablets for Obesity

Viking Therapeutics, Inc., a clinical-stage biopharmaceutical company, has commenced a Phase 2 clinical trial of an oral tablet formulation of VK2735. This dual agonist targets the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors and is being developed in both oral and subcutaneous forms for potential treatment of metabolic disorders such as obesity.

The Phase 2 trial, known as the VENTURE-Oral Dosing Trial, is a randomized, double-blind, placebo-controlled study that will assess the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735 when dosed as an oral tablet once daily for 13 weeks. Approximately 280 adult participants, who are either obese or overweight with at least one weight-related co-morbid condition, will be enrolled. They will be randomly divided into six dosing arms or a placebo group. The primary goal of the study is to measure the change in body weight from baseline after 13 weeks. Additional safety and efficacy measures will also be analyzed as secondary and exploratory endpoints.

Brian Lian, CEO of Viking Therapeutics, highlighted the significance of the VENTURE-Oral Phase 2 study as it moves the VK2735 program into later stages of development. He noted that previous Phase 1 trials over 28 days showed promising results with the tablet formulation, including good tolerability and significant body weight reduction. VK2735 offers a differentiated profile by providing both oral and subcutaneous formulations, potentially leading to reduced risks of side effects and offering flexibility in treatment settings, whether for inducing weight loss or maintaining weight.

Earlier, Viking reported favorable outcomes from a 28-day Phase 1 multiple ascending dose (MAD) study with the VK2735 tablet formulation in healthy volunteers with a BMI of 30 or more. Participants who received VK2735 showed dose-dependent reductions in body weight from baseline, with decreases of up to 8.2%. The weight loss effects persisted through follow-up visits, with reductions reaching 8.3% from baseline four weeks after the final dose. In this assessment, up to 100% of individuals treated with VK2735 achieved at least a 5% weight loss, compared to none in the placebo group. Viking believes further weight reductions might be achievable with treatment durations beyond 28 days.

In the MAD trial, VK2735 demonstrated promising safety and tolerability during 28 days of once-daily dosing at levels up to 100 mg. Most adverse events were mild or moderate, with the majority being mild. Similar results were observed for gastrointestinal adverse events.

Alongside the oral version, Viking is advancing the subcutaneous formulation of VK2735, with Phase 2 VENTURE study data showing successful achievement of primary and all secondary endpoints. Patients using VK2735 experienced significant reductions in mean body weight from baseline, with weight loss progressing through 13 weeks without plateauing. The drug also demonstrated good safety and tolerability, with most adverse events being mild or moderate. Viking plans to advance to Phase 3 development of this formulation in the first half of 2025.