VK2735 Oral / Viking Therap - LARVOL DELTA

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 Announces Completion of Enrollment in Phase 2 VENTURE-Oral Dosing Trial of VK2735 Tablet Formulation in Patients with Obesity (PRNewswire) - "Viking Therapeutics, Inc...announced the completion of subject enrollment in its 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....Viking expects to report data from the study in the second half of 2025."

Enrollment closed • 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

VK2735 for Weight Management Phase 2 (Venture Oral Dosing) (clinicaltrials.gov) - P2 | N=280 | Recruiting | Sponsor: Viking Therapeutics, Inc.

New P2 trial • 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

Viking Therapeutics Announces Initiation of Phase 2 VENTURE-Oral Dosing Trial of VK2735 Tablet Formulation in Patients with Obesity (PRNewswire) - "Viking Therapeutics, Inc...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...The company plans to initiate Phase 3 development with the subcutaneous formulation of VK2735 in the first half of 2025."

New P3 trial • Trial status • Obesity

First-in-Human Study of an Oral Formulation of the GLP-1/GIP Co-Agonist VK2735 in Healthy Adults (OBESITY WEEK 2024) - " Oral VK2735 demonstrated encouraging safety and tolerability following 28 days of once-daily dosing at doses up to 40 mg per day... A oral tablet formulation of the peptide GLP-1/GIP agonist VK2735 demonstrated encouraging signs of weight loss with a benign safety and tolerability profile following 28 days of once-daily dosing in healthy obese volunteers. Further evaluation of the tablet formulation in a Phase 2 trial is planned."

Clinical • P1 data • Gastrointestinal Disorder • Obesity

Viking Therapeutics stock rises on positive Phase 1 weight-loss pill data (Yahoo Finance) - "Viking Therapeutics...reported positive early phase results for its oral weight-loss drug Tuesday, sending the stock soaring more than 25% in early trading. Viking said its Phase 1 results, which are supposed to test the safety of the drug, showed up to 5.3% weight loss in patients after 28 days. The pill showed no safety issues and a majority of side effects were mild — a key differentiator from current market injectable leaders Novo Nordisk (NVO) and Eli Lilly (LLY)."

Stock price • Metabolic Disorders • Obesity

Viking Therapeutics to Highlight Data from Phase 1 Clinical Trial of Dual GLP-1/GIP Receptor Agonist VK2735 in Oral Presentation at ObesityWeek 2023 (Yahoo Finance) - "Viking Therapeutics, Inc...announced that data from the company's Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of VK2735 will be highlighted as part of an oral presentation at ObesityWeek 2023, the annual meeting of The Obesity Society. VK2735 is a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors in development for the potential treatment of various metabolic disorders such as obesity. ObesityWeek 2023 is being held October 14-17, 2023, at the Kay Bailey Hutchison Convention Center in Dallas, Texas."

P1 data • Metabolic Disorders • 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