Clinical Data from Oral and Subcutaneous Doses Show Effective Weight Loss and Support Potential for Long-Term Dosing Strategies
Viking Therapeutics (VKTX), a clinical-stage biopharmaceutical company, recently presented promising data for its VK2735 obesity treatment at ObesityWeek 2024. Findings highlight significant weight loss outcomes, encouraging tolerability, and the potential for monthly dosing regimens.
Viking Therapeutics shared new insights into VK2735, an investigational treatment for obesity and other metabolic disorders, during its presentation at ObesityWeek 2024. VK2735 is a dual agonist targeting glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, both of which are involved in regulating appetite and glucose metabolism. The company’s recent trials have focused on both oral and subcutaneous formulations of VK2735, showcasing its efficacy and tolerability across various dosing regimens.
Oral VK2735: Positive Weight Loss and Safety Profile
In a Phase 1 study of the oral VK2735 tablet, Viking Therapeutics tested doses up to 100 mg daily over 28 days. Patients receiving VK2735 showed significant weight loss, with placebo-adjusted reductions in body weight reaching up to 6.8%. Results demonstrated a dose-dependent effect, with mean weight loss reaching 8.2% from baseline by the end of the treatment period. Additionally, follow-up visits revealed sustained weight loss, with participants maintaining up to an 8.3% reduction in body weight four weeks after the last dose.
Encouragingly, up to 100% of subjects receiving VK2735 achieved a weight reduction of at least 5% over the course of the study, in stark contrast to the placebo group, where no participants met this benchmark. Viking Therapeutics is optimistic about the potential for even greater weight loss with extended dosing beyond 28 days, given the positive weight-loss trajectory observed across multiple dose levels.
Safety results from the Phase 1 study further support the potential for VK2735 as a viable treatment option. Most adverse events were mild to moderate, with gastrointestinal (GI) symptoms—such as nausea, diarrhea, and mild vomiting—being the most commonly reported. Nausea, reported by 32% of VK2735-treated participants, was the most prevalent adverse effect, though it was typically mild. Only 4% of subjects experienced vomiting, with 7% reporting mild diarrhea. Viking’s findings suggest that the oral VK2735 formulation is both effective in promoting weight loss and generally well-tolerated.
Exploring Dose Frequency for Maintenance
In an exploratory cohort within the Phase 1 study, subjects were initially titrated up to 80 mg daily, but then transitioned to an 80 mg dose every other day from Day 15 to Day 28. Despite the lower dosing frequency, participants continued to experience weight loss, reaching a mean reduction of 4% from baseline by Day 28. This result is promising, as it suggests that VK2735’s efficacy can be maintained even with reduced dosing. Viking Therapeutics is investigating whether similar strategies could be applied to help patients sustain weight loss over the long term.
Subcutaneous VK2735 in Phase 2 VENTURE Study: Sustained Weight Loss and Potential Monthly Dosing
In addition to the oral tablet, Viking Therapeutics evaluated a subcutaneous injection of VK2735 in the 13-week Phase 2 VENTURE study. Patients who received weekly doses of VK2735 showed consistent and substantial reductions in body weight, with an average decrease of up to 14.7% from baseline at the study’s end. Weight reduction was progressive, with no indication of plateauing, suggesting that VK2735 may support ongoing weight loss with extended dosing.
An impressive 88% of patients in the VK2735 groups achieved a weight loss of at least 10%, compared to only 4% of those in the placebo group. This robust result indicates that VK2735’s effect on weight loss is both significant and durable. Viking’s pharmacokinetic analysis from the VENTURE study further supports the feasibility of a less frequent dosing regimen. After the final dose, patients retained most of their weight loss, with over 80% of the original reduction maintained up to seven weeks post-treatment, even at the lowest dose of 2.5 mg weekly. The findings highlight the potential for monthly dosing, which could offer a convenient and sustainable option for patients.
Glycemic Impact and Safety Findings
Beyond weight loss, VK2735 also demonstrated positive effects on glycemic control in the VENTURE study. Patients with prediabetic conditions at baseline showed improved glucose levels, and a higher proportion returned to normoglycemic status compared to the placebo group. In addition, VK2735 appeared to prevent the development of prediabetes in patients with initially normal blood glucose levels, with only 2% of VK2735-treated subjects shifting to prediabetic status compared to 31% in the placebo group.
Safety data from the VENTURE study further underscore VK2735’s tolerability, with most treatment-related adverse events classified as mild to moderate. As with the oral formulation, GI issues such as nausea were among the most commonly reported events, occurring in 43% of VK2735-treated subjects compared to 20% of the placebo group. Notably, nausea was predominantly mild, with no severe cases reported. Other adverse events, including vomiting, were generally mild and decreased in frequency as the treatment continued, indicating an adjustment period early in the treatment cycle.
Viking’s Path Forward for VK2735
Viking Therapeutics is preparing to discuss VK2735’s development pathway with the U.S. Food and Drug Administration (FDA), focusing on the potential for the injectable version to offer sustained weight management through longer dosing intervals. Additionally, the company plans to initiate a Phase 2 study of the oral formulation of VK2735 by the end of this year.
“These data demonstrate VK2735’s promising efficacy and tolerability,” said Brian Lian, Ph.D., CEO of Viking Therapeutics. “The VENTURE data underscore the potential for less frequent dosing regimens, which could provide patients with a more manageable long-term treatment option. Our goal is to continue exploring ways to optimize VK2735 to offer sustained weight management.”
As Viking Therapeutics moves forward with its clinical program for VK2735, the company’s latest data highlight the compound’s potential as a flexible and effective weight management therapy with both oral and injectable forms. This versatility could position VK2735 as a valuable option for a range of patients seeking sustainable, clinically significant weight loss solutions.
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