Viking Advances GLP-1/GIP Agonist VK2735 into Late Stage Clinical Program for Obesity

Viking Therapeutics has launched its phase 3 clinical program evaluating VK2735, a once-weekly subcutaneous dual agonist of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, for the treatment of obesity and overweight. The program, announced on June 25, includes two randomized, double-blind, placebo-controlled studies: VANQUISH-1 will enroll approximately 4,500 adults with obesity (body mass index [BMI] 30 kg/m² or greater) or overweight (BMI 27 kg/m² or greater) with at least one weight-related co-morbidity.¹

The phase 3 VANQUISH-2 trial will enroll approximately 1,100 adults with type 2 diabetes (T2D) with overweight or obesity, according to the company announcement.

Viking will evaluate 3 doses of VK2735 in the 2 studies, with participants randomly assigned to receive either 7.5 mg, 12.5 mg, or 17.5 mg or placebo via subcutaneous injection once weekly for 78 weeks. Both trials will evaluate the same primary endpoint, the percent change in body weight from baseline compared to placebo. The company has also identified secondary and exploratory endpoints that include the proportion of participants achieving 5% or greater, 10% or greater, 15% or greater, and 20% or greater weight loss, as well as additional safety and efficacy metrics. At the close of the primary dosing period, participants in both trials will be offered enrollment in an open-label extension for continued treatment.¹

"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," Brian Lian, PhD, chief executive officer of Viking, said in the statement.¹ "Along with the successful initiation of the phase 3 program we continue to make progress on VK2735's broader development," Lian added. He said that Viking will initiate a separate clinical study later this year to evaluate VK2735 as a monthly maintenance treatment¹ and also report results of the company's phase 2 VENTURE-Oral Dosing study, evaluating an oral tablet formulation of VK2735. Findings from the oral dosing study are expected in the second half of 2025.²

The phase 3 program follows positive top-line results from the 2024 phase 2 VENTURE study,³ which met its primary and all secondary endpoints. After 13 weekly doses, VK2735 resulted in statistically significant reductions in mean body weight from baseline of up to 14.7%, with mean weight loss relative to placebo of up to 13.1%, Viking reported. Investigators reported statistically significant differences for all VK2735 doses starting at week 1 and sustained through the study period. Follow-up visits at four and seven weeks post-treatment showed that patients maintained the majority of their weight loss.³

The safety and tolerability profiles of VK2735 in phase 2 were favorable, according to Viking, with most adverse events reported as mild or moderate. The rates of treatment and study discontinuation were similar between participants treated with VK2735 and placebo. Gastrointestinal adverse events, the most commonly reported side effects, were primarily mild or moderate and occurred most frequently during the first week of treatment, with incidence declining thereafter.¹

Viking is also developing VK2809, an oral selective thyroid hormone receptor beta agonist for lipid and metabolic diseases. VK2809 met primary and secondary endpoints in a Phase 2b study in patients with biopsy-confirmed NASH and fibrosis. In a separate Phase 2a study in NAFLD with elevated LDL-C, VK2809 led to statistically significant reductions in both LDL-C and liver fat versus placebo. Viking’s newest program involves a series of internally developed dual amylin and calcitonin receptor agonists (DACRAs) for obesity and other metabolic disorders.¹

References

1. Viking Therapeutics Announces Initiation of Phase 3 Obesity Clinical Program with GLP-1/GIP Agonist VK2735. News release. Viking Therapeutics. June 25, 2025. Accessed June 25, 2025. https://ir.vikingtherapeutics.com/2025-06-25-Viking-Therapeutics-Announces-Initiation-of-Phase-3-Obesity-Clinical-Program-with-GLP-1-GIP-Agonist-VK2735

2. Jennings S. Viking Therapeutics launches phase 2 trial for oral VK2735 in adults with obesity. Patient Care. January 9, 2025. https://www.patientcareonline.com/view/viking-therapeutics-launches-phase-2-trial-for-oral-vk2735-in-patients-with-obesity

3. Halsey G. Viking Therapeutics dual GIP/GLP-1 mimetic drives weight loss of up to 14.7% in phase 2 findings. Patient Care. February 28, 2025. https://www.patientcareonline.com/view/viking-therapeutics-dual-gip-glp-1-mimetic-drives-weight-loss-of-up-to-14-7-in-phase-2-findings