Viking Therapeutics Announces Initiation of VK2735 Oral Maintenance Dosing Clinical Trial in Patients with Obesity

Study purpose and design

Viking announced the start of Part 2 of a maintenance dosing study of VK2735, described as an exploratory trial to evaluate oral and additional subcutaneous maintenance dosing regimens after an initial induction period with weekly subcutaneous doses. The study is randomized, double-blind, and placebo-controlled and will enroll approximately 195 adults with obesity (BMI ≥30 kg/m 2 ) who are otherwise healthy. All participants receive initial weekly subcutaneous doses of VK2735 or placebo for 21 weeks before transitioning to maintenance options that include daily or weekly oral doses, monthly subcutaneous doses, every-other-week subcutaneous doses, or placebo. Primary assessments are safety, tolerability, and pharmacokinetics; exploratory endpoints include changes in body weight from baseline and from Week 21 to Week 33.

Sources: S1

Context from Part 1 and Phase 3 programs

Viking stated that Part 1 of the maintenance study produced positive top-line results evaluating subcutaneous regimens for maintaining initial weight loss achieved with weekly subcutaneous dosing. Parallel to the maintenance program, Viking is conducting two Phase 3 trials of subcutaneous VK2735 (VANQUISH-1 and VANQUISH-2). The company reported VANQUISH-1 is fully enrolled with approximately 4,500 adults without type 2 diabetes and VANQUISH-2 is fully enrolled with approximately 1,000 adults with type 2 diabetes. In the Phase 3 studies, patients are randomized to one of four weekly treatment arms: VK2735 7.5 mg; VK2735 12.5 mg; VK2735 17.5 mg; and placebo.

Sources: S1

Issuer commentary and next steps

Viking’s CEO described the program as seeking flexibility and optionality to support adherence and long-term weight management, and the company said it expects to report results from Part 2 in 2027. The press release reiterates that VK2735 is being developed in both oral and subcutaneous formulations and that the maintenance study follows positive top-line findings from Part 1.

Sources: S1

What remains uncertain

• All clinical statements and expectations in the press release are issuer-provided and forward-looking; the press release identifies risks including the possibility that prior clinical and preclinical results may not be replicated and the outcome, timing, and cost of development are uncertain.
• The release reports 'positive top-line results' from Part 1 but does not supply detailed data, statistical outcomes, or safety findings for independent assessment.
• Enrollment counts, dosing regimens, and timing for Part 2 results are reported by the company and have not been independently verified in the release.