ObesityWeek 2024: Viking Therapeutics Presents New Positive Data from VK2735 Obesity Program

New clinical trial data regarding Viking Therapeutics' VK2735, an investigational dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, will be highlighted at ObesityWeek 2024, being held November 3-6 in San Antonio, Texas.

One poster presentation will summarize results from the company’s phase 2 VENTURE clinical trial, which evaluated 13 weeks of weekly treatment with a subcutaneous formulation of VK2735 in individuals with obesity, according to a Viking Therapeutics' press release. A second poster presentation will highlight findings from the phase 1 multiple ascending dose (MAD) trial of an oral tablet formulation of VK2735 dosed daily for 28 days.

Updated results from VENTURE trial

VENTURE was a randomized, double-blind, placebo-controlled study aimed at assessing the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735. Investigators enrolled 176 adults with obesity or overweight and at least 1 weight-related comorbid condition. The primary endpoint was the percentage change in body weight from baseline to week 13 in patients treated with VK2735 compared to placebo. Secondary endpoints aimed to evaluate a range of additional safety and efficacy measures.

Previous topline results from the VENTURE study showed that participants receiving VK2735 demonstrated up to 14.7% weight loss from baseline, with 88% of patients in the VK2735 group achieving ≥10% weight loss compared to just 4% in the placebo group.

In the presentation given at ObesityWeek 2024, researchers reported new data from a subset of people (n=75) assessed for pharmacokinetic (PK) measures. Findings showed that all participants who received VK2735 maintained the majority of their weight loss at 4 weeks after taking the final dose (P < .0001 vs baseline and placebo, all cohorts), according to Viking’s announcement. This included the lowest dose examined (2.5 mg weekly), for which 98% of the initial weight loss was maintained 4 weeks after the last dose was administered. Moreover, follow-up assessments performed 7 weeks after administration of the final dose showed continued maintenance effects, with over 80% of the original weight loss maintained in the combined PK subset (P < .0005 vs baseline and placebo, all cohorts).

In addition, an exploratory analysis of changes in diabetes status was performed. Investigators observed that VK2735 increased the odds of participants with prediabetic status at baseline to shift to normoglycemic status over 13 weeks. Similarly, the proportion of people with normal glycemic status at baseline transitioning to prediabetic status favored VK2735, with approximately 31% of patients in the placebo group transitioning to prediabetic status, compared with 2% among those in the VK2735 arm, according to Viking.

Data regarding safety and tolerability of VK2735 was the same as previously reported, with the majority (92%) of treatment emergent adverse events (TEAEs) being categorized as mild or moderate.

Updated results from Phase 1 MAD study

In a second poster, researchers reported updated data from the previously reported 28-day MAD study of an oral tablet formulation of VK2735, including new results from participants dosed at 60 mg, 80 mg, and 100 mg daily. Participants in the VK2735 group demonstrated dose-dependent reductions in mean body weight from baseline, ranging up to 8.2%. Additionally, patients demonstrated reductions in mean body weight relative to placebo, ranging up to 6.8%, according to the press release.

Further, an exploratory assessment of the proportion of participants achieving at least 5% weight loss after 28 days showed that up to 100% of people in the VK2735 group achieved ≥5% weight loss, compared with 0% for placebo. Following 28 days of once-daily dosing, oral VK2735 continued to demonstrate encouraging safety and tolerability at doses up to and including 100 mg. The majority (99%) of TEAEs reported were mild or moderate, as well as all observed gastrointestinal adverse events. Additionally, mild nausea was reported in 32% of patients in the VK2735 group and 11% in the placebo group.

"We believe the VENTURE data demonstrate VK2735's promising efficacy and tolerability profile through 13 weeks of weekly dosing and support our belief that less frequent dosing regimens may provide effective maintenance of weight control,” Brian Lian, PhD, CEO, Viking Therapeutics, said in the press release. “The updated oral Phase 1 study results continue to demonstrate an encouraging tolerability profile and promising signs of clinical activity at doses of up to 100 mg daily. We believe the durable effects observed following 28 days of dosing suggest potential opportunities to introduce lower dose regimens following an initial induction of weight loss.”

Lian continued: “We plan to discuss with the FDA the clinical path forward for injectable VK2735 later this quarter and we expect to initiate a Phase 2 study of the oral tablet formulation of VK2735 by the end of this year."

Reference: Viking Therapeutics reports new data from VK2735 obesity program at ObesityWeek® 2024. News release. Viking Therapeutics. November 4, 2024. Accessed November 4, 2024. https://ir.vikingtherapeutics.com/2024-11-04-Viking-Therapeutics-Reports-New-Data-from-VK2735-Obesity-Program-at-ObesityWeek-R-2024