VK2735 Oral / Viking Therap - LARVOL DELTA

A Phase 1 Study of VK2735 in Obese Adults Without Comorbidities (clinicaltrials.gov) - P1 | N=270 | Recruiting | Sponsor: Viking Therapeutics, Inc.

New P1 trial • Obesity

Viking Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update (PRNewswire) - "Oral Phase 3 VK2735 Trial Initiation Expected 4Q26."

New P3 trial • Obesity

Pipeline and Recent Corporate Highlights (PRNewswire) - "Phase 3 VANQUISH 1 & 2 Trials for Subcutaneous VK2735 in Obesity Fully Enrolled and Advancing...During the second quarter, both VANQUISH studies continued to proceed according to plan....VK2735 Maintenance Dosing Study Data Expected 3Q26...Exploratory endpoints will assess change in body weight from baseline, as well as change in body weight before and after transitioning to maintenance dosing."

P1 data • Trial status • Obesity • Type 2 Diabetes Mellitus

The company plans to initiate a Phase 3 trial to evaluate oral VK2735 for the treatment of obesity and overweight later this year (PRNewswire)

New P3 trial • Obesity

Viking Therapeutics Presents Data from its 13-Week Phase 2 VENTURE-Oral Dosing Trial of VK2735 at European Congress on Obesity (ECO) 2026 (PRNewswire) - "Participants receiving once-daily oral VK2735 demonstrated statistically significant, dose-dependent weight loss from baseline of up to 12.2% (26.6 lbs) at 13 weeks across all dose cohorts. Compared with placebo, doses >15 mg demonstrated dose-dependent and progressive weight loss starting early in treatment and continuing through the 13-week treatment window, with no plateau. Up to 97% of VK2735-treated participants achieved ≥5% weight loss, and up to 80% achieved ≥10%, compared with 10% and 5%, respectively, for placebo...Across all dose cohorts, the male-to-female ratio ranged from 15:85 to 45:55...'We look forward to initiating Phase 3 trials with the tablet later this year.'"

New P3 trial • P2 data • Obesity

Treatment with Oral VK2735 Results in Significant Weight Loss: the Randomized, Placebo-Controlled, Dose-Finding VENTURE-2 Study (ECO 2026) - P2 | "Treatment discontinuation rates were 18% with placebo vs 20-38% with VK2735 and study discontinuation rates were 5% with placebo vs 8-13% with VK2735 in this dose-finding study. Preliminary findings with an oral tablet formulation of VK2735 show significant weight reduction in a short time span and a tolerability profile consistent with the clinical trial experience with activation of the incretin axis. Funding: Research relating to this abstract was funded by Viking Therapeutics, Inc Statistically significant differences in % change in body weight vs baseline and placebo were observed for all VK2735 doses >15 mg starting at Week 1 and continuing through 13 weeks. Fig."

Clinical • Constipation • Diabetes • Dyslipidemia • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Hypertension • Immunology • Metabolic Disorders • Obesity • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder • Type 2 Diabetes Mellitus

Viking Therapeutics Announces Two Poster Presentations at European Congress on Obesity (ECO) 2026 (PRNewswire) - "At ECO, Viking will present a poster highlighting data from its Phase 2 VENTURE-Oral Dosing trial, focusing on key efficacy and safety endpoints, including weight loss and tolerability during the 13-week study. The second poster will highlight the design and enrollment demographics of the ongoing Phase 3 VANQUISH-1 study of subcutaneous VK2735 in adults with obesity or who are overweight and have at least one weight-related comorbidity."

P2 data • Trial status • Obesity

Pipeline and Recent Corporate Highlights (PRNewswire) - "Phase 3 VANQUISH Trials for Subcutaneous VK2735 in Obesity Advance; VANQUISH-1 and VANQUISH-2 Trials Fully Enrolled...Initiation of Phase 3 Oral VK2735 Trial for Obesity Expected 4Q26...VK2735 Maintenance Dosing Study Advances; Data Expected 3Q26....During the first quarter, the company filed an Investigational New Drug (IND) application for its lead amylin agonist VK3019. The company plans to initiate a Phase 1 trial evaluating VK3019 in 2Q26."

IND • New P1 trial • New P3 trial • P3 data • Obesity • Type 2 Diabetes Mellitus

VK2735 Phase 1 Maintenance Dosing Study Fully Enrolled; Data Expected 3Q26. (PRNewswire) - "This trial is a randomized, double-blind, placebo-controlled trial in approximately 180 adults with obesity (BMI ≥30 kg/m2). All participants will receive initial weekly subcutaneous doses of VK2735 or placebo for 19 weeks."

Enrollment closed • P1 data • Obesity

Oral VK2735 to Advance into Phase 3 Trials, Expected to Begin 3Q26. (PRNewswire)

New P3 trial • Obesity

Viking Therapeutics Announces Completion of Enrollment in Maintenance Dosing Clinical Trial of VK2735 in Obesity (PRNewswire) - "The trial enrolled approximately 180 adults with BMI ≥30 kg/m2 but who are otherwise healthy...All enrolled participants receive initial weekly subcutaneous doses of VK2735 or placebo for 19 weeks. Following Week 19, participants are transitioned to a range of VK2735 maintenance dosing regimens including weekly, every other week, or monthly subcutaneous dosing, as well as daily oral dosing, weekly oral dosing, or placebo....'We look forward to reporting the results of this important study later this year.'"

Enrollment closed • P1 data • Obesity

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

Trial completion • Obesity

Viking Therapeutics Announces Positive Top-Line Results from Phase 2 VENTURE-Oral Dosing Trial of VK2735 Tablet Formulation in Patients with Obesity (PRNewswire) - "Participants receiving VK2735 also demonstrated statistically significant reductions in mean body weight relative to placebo, ranging up to 10.9%. Reductions in body weight were progressive at all doses through the course of the study, with no plateau observed for weight loss at 13 weeks....All doses of VK2735 >15 mg also demonstrated statistically significant differences relative to placebo on the key secondary endpoint assessing the proportion of subjects demonstrating at least 5% and 10% weight loss."

P2 data • Obesity

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 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