Viking Therapeutics Launches Phase 2 Trial for Oral VK2735 in Patients with Obesity
The trial builds on results from a previous phase 1 study that showed dose-dependent weight loss and favorable tolerability for VK2735 in people with obesity.
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Viking Therapeutics has announced the initiation of a phase 2 clinical trial evaluating an oral tablet formulation of VK2735, a dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, for the potential treatment of obesity.
The VENTURE-Oral Dosing Trial is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety, tolerability, pharmacokinetics, and weight loss efficacy of once-daily oral VK2735 over 13 weeks, according to the company’s January 8, 2025, press release.
The trial will enroll approximately 280 adults with obesity (body mass index [BMI] ≥30 kg/m2 or overweight (BMI ≥27 kg/m2) with at least 1 weight-related comorbidity. Participants will be randomized to 1 of 6 dosing arms or placebo. The primary endpoint is the percent change in body weight from baseline after 13 weeks. The primary endpoint is the percentage change in body weight from baseline, while secondary and exploratory endpoints will assess additional safety and efficacy measures.
“The VENTURE-Oral Phase 2 study represents a significant milestone as we advance two formulations of VK2735 into later-stage development,” Brian Lian, PhD, chief executive officer of Viking Therapeutics, said in the press release. “Our data suggest VK2735 offers a differentiated profile, providing patients with a choice of either oral or subcutaneous administration for weight management.”
The VENTURE-Oral Dosing trial builds on encouraging data from a 28-day phase 1 multiple ascending dose (MAD) study of the tablet formulation of VK2735 in healthy individuals with obesity. Results showed that people receiving VK2735 demonstrated dose-dependent reductions in body weight, with mean decreases ranging up to 8.2%. Sustained weight loss effects were observed at follow-up through day 57, with reductions of up to 8.3% recorded 4 weeks after the final dose. Notably, up to 100% of VK2735-treated participants achieved at least 5% weight loss within 28 days, compared with 0% in the placebo group.
The phase 1 trial also highlighted VK2735’s safety and tolerability. Most treatment-emergent adverse events were mild or moderate (99%), with gastrointestinal symptoms being the most common.
Viking Therapeutics is concurrently developing a subcutaneous formulation of VK2735, which recently achieved all primary and secondary endpoints in a separate phase 2 study. This formulation demonstrated weight loss of up to 14.7% without plateauing over 13 weeks, and the company plans to advance it to phase 3 trials in 2025.
Reference: Viking Therapeutics Announces Initiation of Phase 2 VENTURE-Oral Dosing Trial of VK2735 Tablet Formulation in Patients with Obesity. News release. Viking Therapeutics. January 8, 2025. Accessed January 9, 2025. https://ir.vikingtherapeutics.com/2025-01-08-Viking-Therapeutics-Announces-Initiation-of-Phase-2-VENTURE-Oral-Dosing-Trial-of-VK2735-Tablet-Formulation-in-Patients-with-Obesity
