VK2735 SC / Viking Therap - LARVOL DELTA

Viking Therapeutics Announces Initiation of Phase 3 Obesity Clinical Program with GLP-1/GIP Agonist VK2735 (PRNewswire) - "Viking Therapeutics...announced the initiation of the VANQUISH Phase 3 clinical program for VK2735....The VANQUISH Phase 3 program includes two studies evaluating VK2735....Each study is a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks. The VANQUISH-1 study will target enrollment of approximately 4500 adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition. The VANQUISH-2 study will target enrollment of approximately 1100 adults with type 2 diabetes who are obese or overweight. Participants in both trials will be randomized to one of four weekly treatment arms: VK2735 7.5 mg, VK2735 12.5 mg, VK2735 17.5 mg, and placebo....'We...expect to report the results of the Phase 2 VENTURE-Oral Dosing study in the second half of this year'."

New P3 trial • P2 data • Obesity

Viking Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update (PRNewswire) - "Phase 3 Trials for Subcutaneous VK2735 Expected to Begin 2Q25; Phase 2 VENTURE-Oral Dosing Trial in Obesity Fully Enrolled; Data Expected 2H25; Broad Manufacturing Agreement with CordenPharma to Support Future Commercialization of VK2735; Strong Quarter-End Cash Position of $852 Million"

Commercial • New P3 trial • P2 data • Obesity

Viking Therapeutics Signs Broad Manufacturing Agreement With CordenPharma to Support Commercialization of VK2735 (PRNewswire) - "Viking Therapeutics, Inc...announced that it has signed a broad, multi-year manufacturing agreement with CordenPharma, an industry-leading contract development and manufacturing organization (CDMO), covering both the active pharmaceutical ingredient (API) and final finished product supply for its VK2735 program for obesity. The agreement provides Viking with sufficient long-term supply of both subcutaneous and oral VK2735 product forms to support a potential multi-billion-dollar annual product opportunity. Under the terms of the agreement, Viking has secured dedicated capacity for the manufacture of, and a commitment to supply annually, multiple metric tons of VK2735 API. In addition, CordenPharma will provide fill/finish capacity for both the injectable and oral formulations of VK2735.... Additionally, the company plans to initiate Phase 3 development with the subcutaneous formulation of VK2735 in the second quarter of 2025."

Commercial • New P3 trial • Obesity

Phase 1 Study to Evaluate the Safety and Tolerability of VK2735 (clinicaltrials.gov) - P1 | N=92 | Completed | Sponsor: Viking Therapeutics, Inc. | Recruiting ➔ Completed | N=136 ➔ 92 | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Nov 2023 ➔ Nov 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

Viking Therapeutics Reports Fourth Quarter and Year-End 2024 Financial Results and Provides Corporate Update (PRNewswire) - "Initiation of Phase 3 Studies for Subcutaneous VK2735 for Obesity Planned for 2Q25. Phase 2 VENTURE-Oral Dosing Trial Evaluating VK2735 in Obesity Underway....The primary endpoint of the study is the percent change in body weight from baseline after 13 weeks of treatment....The company expects to report data from this study in 2H25....Best-in-Class Data from Phase 2b VOYAGE Trial in MASH Highlighted in Oral Late Breaker Presentation at The Liver Meeting 2024....Dual Amylin and Calcitonin Receptor Agonist (DACRA) Program Ongoing; IND Planned for 2025...Viking is evaluating an internally developed dual amylin and calcitonin receptor agonist (DACRA) program for the potential treatment of obesity."

IND • Late-breaking abstract • New P3 trial • P2 data • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

Results From the 13-Week VENTURE Phase 2a Study of the GLP-1/GIP Co-Agonist VK2735 in Obese Subjects (OBESITY WEEK 2024) - " The Phase 2 VENTURE trial was a randomized, double-blind, placebo-controlled study intended to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735, administered subcutaneously, once weekly for 13 weeks in 176 adults who are obese (BMI ≥30 kg/m2), or adults who are overweight (BMI ≥27 kg/m2) with at least one weight-related comorbid condition... The Phase 2 VENTURE trial successfully achieved its primary endpoint and all secondary endpoints, with patients receiving VK2735 demonstrating statistically significant reductions in body weight compared with placebo. These results support further evaluation of VK2735 in a longer-term clinical study."

Clinical • P2a data • Diabetes • Gastrointestinal Disorder • Genetic Disorders • Obesity • Type 2 Diabetes Mellitus

Viking Therapeutics Announces Positive Top-Line Results from Phase 2 VENTURE Trial of Dual GLP-1/GIP Receptor Agonist VK2735 in Patients with Obesity (PRNewswire) - P3 | N=125 | VENTURE (NCT06068946) | Sponsor: Viking Therapeutics, Inc. | "Viking Therapeutics, Inc...today announced positive top-line results from the company's Phase 2 clinical trial of VK2735....The Phase 2 VENTURE trial successfully achieved its primary endpoint and all secondary endpoints, with patients receiving VK2735 demonstrating statistically significant reductions in body weight compared with placebo....Based on these findings, Viking intends to meet with the FDA and discuss next steps in the development of VK2735....Patients receiving weekly doses of VK2735 demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to 14.7% from baseline. Patients receiving VK2735 also demonstrated statistically significant reductions in mean body weight relative to placebo, ranging up to 13.1%."

P2 data • Metabolic Disorders • Obesity

Viking Therapeutics Announces Completion of Enrollment in Phase 2 VENTURE Trial of Dual GLP-1/GIP Receptor Agonist VK2735 in Patients with Obesity (PRNewswire) - P2 | N=125 | VENTURE (NCT06068946) | Sponsor: Viking Therapeutics, Inc. | "Viking Therapeutics, Inc...announced the completion of patient enrollment in its 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. Viking expects to report data from the study in the first half of 2024."

Enrollment closed • P2 data • Metabolic Disorders • Obesity

Viking Therapeutics Presents New Data from Phase 1 Clinical Trial of Dual GLP-1/GIP Receptor Agonist VK2735 in Oral Presentation at ObesityWeek 2023 (PRNewswire) - P1 | N=136 | NCT05203237 | Sponsor: Viking Therapeutics, Inc. | "Viking Therapeutics, Inc...announced that new results from the company's Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of VK2735 were featured in an oral presentation at ObesityWeek 2023, the annual meeting of The Obesity Society...results demonstrated reductions in liver fat content, both as compared to baseline and as compared to placebo. Subjects receiving VK2735 experienced reductions in liver fat ranging up to 47.2% from baseline....Study investigators also evaluated the change in subjects' levels of plasma lipids, including apolipoprotein B (ApoB), low-density lipoprotein cholesterol (LDL-C), and total cholesterol, following 28 days of once-weekly treatment with VK2735."

P1 data • PK/PD data • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Obesity

Phase 1 Study to Evaluate the Safety and Tolerability of VK2735 (clinicaltrials.gov) - P1 | N=136 | Recruiting | Sponsor: Viking Therapeutics, Inc. | N=88 ➔ 136

Enrollment change • Hepatology • Non-alcoholic Steatohepatitis

Viking Therapeutics Announces Initiation of Phase 2 VENTURE Trial of Dual GLP-1/GIP Receptor Agonist VK2735 in Patients with Obesity (PRNewswire) - "Viking Therapeutics, Inc...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....Viking is also conducting a Phase 1 trial of a novel oral formulation of VK2735...The company expects to report initial data from the oral formulation Phase 1 study in the fourth quarter of 2023."

P1 data • Trial status • Metabolic Disorders • Obesity