Viking Therapeutics Advances 3 Potential Obesity Treatments Based on Promising 2024 Clinical Trial Results

Viking Therapeutics, Inc announced its plans for continued development of potential therapies for obesity and other metabolic disorders in a February 5 report of year-end 2024 financials and other corporate news. Of the scientific results provided, Viking CEO Brian Lian, PhD, said, "Each of these studies successfully achieved their objectives with each in our view demonstrating best-in-class data."¹

Subcutaneous VK2735. The company plans to initiate phase 3 clinical trials for once-weekly subcutaneous VK2735, a dual glucagon-like peptide 1/gastric inhibitory polypeptide (GLP-1/GIP) receptor agonist for the potential treatment of obesity and other metabolic disorders, in the second quarter of 2025.

This decision follows strong results from the phase 2 VENTURE trial,² in which VK2735 led to statistically significant reductions in mean body weight from baseline of up to 14.7% after 13 weeks and of up to 13.1% compared with placebo.² The separation from placebo for weight loss for all doses of VK2735 began as early as the first week and were sustained through study end. Cohorts that received the study drug maintained weight loss through 7 weeks after receiving the final dose. The investigational drug demonstrated a favorable safety profile, with most gastrointestinal adverse events being mild or moderate and generally declining throughout the study.²

During an End-of-phase 2 meeting with the FDA, Viking received feedback on the company’s proposed plans for the phase 3 program as well as overall development for the GLP-1/GIP receptor agonist. The VENTURE findings were presented at ObesityWeek 2024.

Oral formulation. The company is also evaluating an oral formulation of VK2735³ and announced that a 13-week phase 2a trial (VENTURE-Oral Dosing) is currently underway with plans to report data in the second half of 2025, the company stated.¹ The randomized double-blind, placebo-controlled multicenter study is evaluating the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 dosed as an oral tablet once daily.

VENTURE-Oral Dosing will enroll a cohort of 280 adults who have obesity or who have overweight with at least one weight-related comorbid condition. Based on random assignment, participants will receive 1 of 6 VK2735 doses or placebo. The primary endpoint is the percent change in body weight at study week 13 with secondary and exploratory endpoints established to assess a range of safety and efficacy measures.¹

This study follows positive results of the phase 1 dose-finding study,³ also announced at ObesityWeek 2024, which showed dose-dependent reductions in mean body weight of up to 8.2% and persistent weight loss effects through study day 57. The weight loss trajectories observed in the phase 1 trial of doses up to 100 mg suggest that treatment beyond the 28-day period will provide additional benefits, Viking suggested at the time. ³

The oral administration route has a number of benefits that include the potential to transition individuals from the subcutaneous formulation to the same molecule taken by mouth. The tablet also could be more acceptable to some who are hesitant to commit to subcutaneous injections, the company suggested.¹

DACRA. Viking is also developing a novel dual amylin and calcitonin receptor agonist (DACRA) for the potential treatment of obesity, which demonstrated significant reductions in food intake and body weight in preclinical models. An investigational new drug (IND) application for this program is planned for later this year, according to the release. The early topline data were presented during the American Diabetes Association 2024 Annual Scientific Sessions.¹

MASH. Additionally, Viking reported positive findings from the phase 2b VOYAGE trial of VK2809 for metabolic dysfunction-associated steatohepatitis (MASH). The study demonstrated significant liver fat reduction of 38% to 55% and improvements in MASH resolution and fibrosis. The company also highlighted favorable effects of VK2809 on plasma lipids, including reductions in low-density lipoprotein cholesterol and atherogenic proteins. Viking is evaluating next steps in the development program for VK2809.¹

Reporting on the strength of the 2024 balance sheet, CEO Lian said the company has the "resources to achieve important clinical goals, including the completion of Phase 3 trials for VK2735 in obesity."

References
1. Viking Therapeutics reports fourth quarter and year-end 2024 financial results and provides corporate update. News release. Viking Therapeutics. February 5, 2025. Accessed February 6, 2025. https://prnmedia.prnewswire.com/news-releases/viking-therapeutics-reports-fourth-quarter-and-year-end-2024-financial-results-and-provides-corporate-update-302369377.html
Jennings S. Viking Therapeutics launches phase 2 trial for oral VK2735 in patients with obesity. Patient Care Online. January 9, 2025. https://www.patientcareonline.com/view/viking-therapeutics-launches-phase-2-trial-for-oral-vk2735-in-patients-with-obesity
3. Halsey G. Viking Therapeutics oral antiobesity agent returns positive results in small study. Patient Care Online. March 27, 2024. https://www.patientcareonline.com/view/viking-therapeutics-oral-antiobesity-agent-returns-positive-results-in-small-study