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Viking Therapeutics Announces Initiation of Phase 2 VENTURE Trial of Dual GLP-1/GIP Receptor Agonist VK2735 in Patients with Obesity
13-Week Study to Evaluate the Safety and Efficacy of VK2735 Dosed Weekly SAN DIEGO, Sept. 6, 2023 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ:
About this update from Viking Therapeutics, Inc.
[{"type":"text","content":"13-Week Study to Evaluate the Safety and Efficacy of VK2735 Dosed Weekly\nSAN DIEGO, Sept. 6, 2023 /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 VK2735, the company's wholly-owned dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. VK2735 is in development for the potential treatment of various metabolic disorders such as obesity.\n\n \n \n \n \n \n \n\n \nThe Phase 2 VENTURE trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of four different doses of VK2735, administered subcutaneously, once weekly. The 13-week trial will enroll approximately 125 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. The primary endpoint of the study is the percent change in body weight from baseline to Week 13, with secondary and exploratory endpoints evaluating a range of additional safety and efficacy measures.\n\"We are excited to announce the initiation of the VENTURE study, which will build upon the promising VK2735 Phase 1 data we reported earlier this year,\" said Brian Lian, Ph.D., chief executive officer of Viking. \"Obesity is a major healthcare challenge, and recent data confirm that effective weight loss agents can reduce a patient's cardiovascular risk profile, providing important health benefits. We look forward to exploring VK2735's safety and weight loss efficacy over this study's 13-week dosing window.\"\nViking previously reported positive results from a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of VK2735 in healthy volunteers with a BMI ≥30. In the SAD portion of the study, VK2735 demonstrated promising safety and tolerability, as well as a predictable pharmacokinetic profile. In the 28-day MAD portion of the study, VK2735 was well-tolerated and showed positive signs of clinical activity. All MAD cohorts receiving VK2735 experienced reductions in mean body weight from baseline, ranging up to 7.8%. Cohorts receiving VK2735 also demon...