Dual GLP-1/GIP Receptor Agonist Shows Positive Results in Phase 2 Study

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Viking Therapeutics’ VK2735 met both of its primary and secondary endpoints in the VENTURE trial, demonstrating statistically significant reductions in body weight compared to placebo.

A dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist from Viking Therapeutics has demonstrated positive top-line results in a phase 2 study for the potential treatment of various metabolic disorders such as obesity, the company announced in a release.1

Scale and measuring tape for weight loss / 9dreamstudio - stock.adobe.com

Scale and measuring tape for weight loss / 9dreamstudio - stock.adobe.com

Results from the phase 2 VENTURE trial (NCT06068946) showed the GLP-1/GIP receptor agonist (VK2735) met its primary endpoint and demonstrated statistically significant reductions in body weight compared to placebo. The treatment also met the secondary endpoint and was seen to be safe and well tolerated, with most adverse events being mild or moderate.

Key Takeaways

  • Viking Therapeutics has reported positive top-line results from the phase 2 VENTURE trial for VK2735, a dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist.
  • The VENTURE trial evaluated the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735 in 176 adults with obesity or overweight and at least one weight-related comorbid condition. The trial demonstrated that VK2735 met its primary endpoint by achieving statistically significant reductions in body weight compared to placebo.
  • Viking Therapeutics plans to meet with the FDA to discuss the next steps for the development of VK2735 based on the positive results. The company aims to progress the therapy into further clinical development later this year. Additionally, data from a Phase 1 study of an oral formulation of VK2735 is expected to be reported later in the quarter.

"We are excited to report the top-line results from this important Phase 2 study,” Brian Lian, CEO of Viking, said in a release.1 “VK2735 continues to demonstrate a promising efficacy and tolerability profile following 13 weeks of repeat dosing in obese subjects. 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.”

The phase 2 VENTURE trial was a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735. The study enrolled 176 adults with obesity or overweight with at least 1 comorbid condition related to weight. The participants received either 2.5 mg, 5 mg, 10 mg, or 15 mg of VK2735 once a week administered subcutaneously or placebo for a total of 13 weeks.

READ MORE: Short-Acting GLP-1 RAs Linked With Increased Risk of GERD, Barret’s Esophagus

The study showed that patients receiving VK2735 had statistically significant reductions in mean body weight after 13 weeks and mean body weight relative to placebo, ranging up to 14.7% and 13.1% from baseline, respectively. Reductions in body weight were progressive throughout the study period and were observed for all doses. No plateau was observed at 13 weeks. All doses showed statistically significant differences compared to placebo in patients who experienced at least 10% weight loss: 88% of treated patients had 10% or more weight loss, compared to 4% in placebo.

VK2735 also demonstrated strong safety and tolerability. The majority of treated patients with adverse reactions reported them as either mild or moderate in severity, with the most common being gastrointestinal issues, such as nausea and vomiting. A total of 23 patients discontinued treatment during the study, 18 among those treated with VK2735 and 8 in the placebo cohort. These adverse events were generally seen early in the study and decreased upon repeat dosing.

In response to the positive data on VK2735 from the phase 2 VENTURE trial, Viking said that it intends to meet with the FDA in the near future to open up discussion on what the next steps are for the development of the treatment.

“We look forward to progressing this important therapy into further clinical development later this year,” Lian said. “Separately, we remain on track to report data from a Phase 1 study of an oral formulation of VK2735 later this quarter."

GLP-1 agonists—such as semaglutide (Ozempic)—have skyrocketed in popularity recently due to the positive effects they have on weight loss. Researchers have also been exploring the potential benefits of co-activating the GIP receptor to enhance the therapeutic benefits of GLP-1 receptor activation.

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 29, 2024. https://ir.vikingtherapeutics.com/2024-02-27-Viking-Therapeutics-Announces-Positive-Top-Line-Results-from-Phase-2-VENTURE-Trial-of-Dual-GLP-1-GIP-Receptor-Agonist-VK2735-in-Patients-with-Obesity
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