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Viking Therapeutics Announces Initiation of Phase 2 VENTURE-Oral Dosing Trial of VK2735 Tablet Formulation in Patients with Obesity
13-Week Study to Evaluate the Safety and Efficacy of Oral VK2735 Dosed Once Daily SAN DIEGO, Jan. 8, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking")
About this update from Viking Therapeutics, Inc.
[{"type":"text","content":"13-Week Study to Evaluate the Safety and Efficacy of Oral VK2735 Dosed Once Daily\nSAN DIEGO, Jan. 8, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. (\"Viking\") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the initiation of a Phase 2 clinical trial of the oral tablet formulation of VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. VK2375 is being developed in both oral and subcutaneous formulations for the potential treatment of various metabolic disorders such as obesity.\n\n \n \n \n \n \n \n\n \nThe Phase 2 VENTURE-Oral Dosing Trial is a randomized, double-blind, placebo-controlled multicenter study designed to evaluate the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 dosed as an oral tablet once daily for 13 weeks. The trial will enroll approximately 280 adults who are obese (BMI ≥30 kg/m2), or adults who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition. Patients will be evenly randomized to one of six dosing arms or placebo. The primary endpoint of the study is the percent change in body weight from baseline after 13 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures.\n\"The VENTURE-Oral Phase 2 study represents an important milestone for the VK2735 program as we advance two formulations of this compound into later-stage development,\" said Brian Lian, chief executive officer of Viking Therapeutics. \"Prior 28-day Phase 1 data demonstrated encouraging tolerability with the tablet formulation, as well as promising reductions in body weight. We believe VK2735's clinical results to-date suggest a differentiated profile, with the potential to provide patients and clinicians the option of two well-tolerated formulations, administered by either subcutaneous injection or as a tablet, that each utilize the same active pharmaceutical ingredient. This may reduce the potential risk of unexpected side effects and provide flexibility for use in either the induction of weight loss or for prevention of weight gain, as in a maintenance setting.\"\nViking previously reported positive results from a 28-day P...