Investigational GLP-1 Medication Found to Reduce Body Weight

Positive topline results from a phase 2 clinical trial evaluating VK2735 (Viking Therapeutics), a dual agonist of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), demonstrated statistically significant reductions in body weight compared to a placebo. The drug is currently being developed as a potential treatment for various metabolic disorders, including obesity, according to a press release from the company.¹

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"VK2735 continues to demonstrate a promising efficacy and tolerability profile following 13 weeks of repeat dosing in obese subjects," Brian Lian, PhD, CEO of Viking Therapeutics, said in a press release from the company. "Notably, robust weight loss compared with placebo was observed early across all doses evaluated in the VENTURE study and continued throughout the treatment period in all treatment groups. No evidence of a plateau was observed at Week 13 for any VK2735 dose, suggesting further weight loss might be achieved from extended dosing periods."¹

The VENTURE (NCT06068946) phase 2 trial is a randomized, double-blinded study to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of the drug, which is administered as a subcutaneous injection once weekly. Investigators included 176 adults for the 13-week trial. Individuals were either obese, with a body mass index of 30 kg/m2 or greater, or were overweight, with a BMI of 27 kg/m2 or greater and at least 2 weight related comorbidities, according to the press release.¹

The primary endpoint included body weight change from baseline to week 13 for those treated with the investigational drug compared to the placebo. The secondary endpoint included the proportion of individuals who lost 5% or greater and 10% or greater of their baseline weight by Week 13, and the safety measures included the incidence of treatment-emergent adverse events (TEAEs), according to the clinical trial information.²

Investigators found that there was a statistically significant reduction in mean body weight at week 12, ranging up to 14.7%, according to the press release. Additionally, the investigational drug also showed mean body weight reductions relative to the placebo up to 13.1%. There were also statistically significant differences relative to the placebo for all doses regarding the secondary endpoint of those having at least 10% weight loss. They found that up to 88% of individuals in the VK2735 treatment group achieved 10% or greater weight loss compared to 4% for the placebo, according to the press release.¹

Furthermore, VK2735 had encouraging safety and tolerability with a low discontinuation rate of 14% in the placebo group and 13% in the VK2735 group. Approximately 92% of drug related TEAEs were mild or moderate in severity and 95% were gastrointestinal. Nausea was reported in approximately 43% of those receiving VK2735 and 20% receiving the placebo.¹

Nausea was generally reported as mild at 68% and 32% were moderate, but none were severe. Approximately 18% reported vomiting in the VK2735 group with none in the placebo group. Investigators reported that GI-related AEs were generally observed early in treatment and decreased in frequency with more dosing. One individual who received VK2735 experienced a serious AE of dehydration that was related to the study drug, according to the press release.¹

Reference

1. Viking Therapeutics Announces Positive Top-Line Results from Phase 2 VENTURE Trial of Dual GLP-1/GIP Receptor Agonist VK2735 in Patients with Obesity. News release. Viking Therapeutics. February 27, 2024. Accessed February 28, 2024. https://prnmedia.prnewswire.com/news-releases/viking-therapeutics-announces-positive-top-line-results-from-phase-2-venture-trial-of-dual-glp-1gip-receptor-agonist-vk2735-in-patients-with-obesity-302072459.html

2. VK2735 for Weight Management Phase 2. ClinicalTrials.gov. Updated October 5, 2023. Accessed February 28, 2024. https://clinicaltrials.gov/study/NCT06068946