Viking Therapeutics Completes Enrollment for Phase 2 Trial of Oral Obesity Tablet

Viking Therapeutics, Inc, announced today the completion of participant enrollment in its phase 2 clinical trial evaluating the safety and efficacy of oral VK2735, a dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) (GLP-1/GIP) receptor agonist, for the treatment of obesity. ¹

The 13-week VENTURE-Oral Dosing Trial, has enrolled approximately 280 adults with obesity (body mass index [BMI] of 30 kg/m² or higher) or overweight (BMI of 27 kg/m2 or higher) with at least one weight-related comorbidity. Viking expects to report study data in the second half of 2025, according to the announcement.¹

VENTURE-Oral Dosing, a randomized, double-blind, placebo-controlled study, will assess the percent change in body weight from baseline after 13 weeks of treatment as its primary endpoint. Participants have been randomly assigned to receive one of 6 dosing regimens or placebo. Secondary and exploratory endpoints will evaluate additional safety and efficacy measures, Viking stated.

"Despite its larger size, VENTURE-Oral was rapidly enrolled, highlighting the continued enthusiasm for new obesity therapeutics such as VK2735. We look forward to reporting data from this trial in the second half of 2025," Viking CEO, Brian Lian, PhD, said in the announcement.

Previous data from a 28-day phase 1 multiple ascending dose (MAD) trial of oral VK2735 demonstrated dose-dependent weight reductions, with mean weight loss reaching up to 8.2% at the end of the dosing period and 8.3% at follow-up.² All VK2735-treated participants achieved at least 5% weight loss, compared to 0% in the placebo group. The treatment was generally well tolerated, with 99% of adverse events reported as mild or moderate, including gastrointestinal side effects, of which 84% were mild.²

In parallel, Viking is advancing a subcutaneous formulation of VK2735, which achieved statistically significant weight loss results in a separate phase 2 VENTURE study.³ Study participants receiving subcutaneous VK2735 experienced mean weight reductions of up to 14.7%, with weight loss continuing through the 13-week study without signs of plateauing. Viking plans to initiate phase 3 development of the subcutaneous formulation in the first half of 2025.³

In its announcement, Viking noted the success of GLP-1 receptor agonists for management of hyperglycemia associated with type 2 diabetes as well obesity and overweight, pointing to the marketed formulations of semaglutide, and the parallel efficacy seen with the dual GLP-1/GIP receptor agonist tirzepatide.¹

References
1. Viking Therapeutics announces completion of enrollment in phase 2 VENTURE-Oral Dosing Trial of VK2735 tablet formulation in patients with obesity. News release. Viking Therapeutics. March 26, 2025. Accessed march 26, 2025. https://ir.vikingtherapeutics.com/2025-03-26-Viking-Therapeutics-Announces-Completion-of-Enrollment-in-Phase-2-VENTURE-Oral-Dosing-Trial-of-VK2735-Tablet-Formulation-in-Patients-with-Obesity
2. Halsey G. Viking Therapeutics oral antiobesity agent returns positive results in small study. Patient Care. March 27, 2024. https://www.patientcareonline.com/view/viking-therapeutics-oral-antiobesity-agent-returns-positive-results-in-small-study
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, 2024. https://www.patientcareonline.com/view/viking-therapeutics-dual-gip-glp-1-mimetic-drives-weight-loss-of-up-to-14-7-in-phase-2-findings