Don Tracy, Associate Editor

Reportedly, the oral weight loss pill VK2735 showed promising signs of effectiveness and a tolerable safety profile.
Today, Viking Therapeutics announced promising results from a Phase I trial of VK2735, an investigational oral tablet targeting both GLP-1 and GIP receptors for the treatment of metabolic disorders, such as obesity. Results from the 28-day trial show that patients administered VK2735 experienced up to 5.3% weight loss, Additionally, 57% achieved more than 5% in weight loss resulting from treatment with VK2735, a major difference compared to those treated with a placebo. The tablet’s safety profile was reported to be well tolerated, with most adverse effects (AEs) being mild and no serious AEs reported.1
"These Phase I results highlight VK2735's promising early weight loss and tolerability profile when dosed as an oral tablet," said Brian Lian, PhD, CEO, Viking, in a press release. "We believe these data indicate that longer treatment duration, at potentially higher doses, may result in additional weight loss. We are particularly pleased with the initial safety and tolerability data, which suggest a differentiated profile with minimal gastrointestinal-related side effects. We believe that an oral agent with good tolerability could represent an attractive potential treatment option for patients with obesity. We look forward to exploring longer treatment windows and potentially higher doses in an upcoming Phase 2 trial."
Viking plans on starting their Phase II trial to further explore VK2735's efficacy and safety in obesity treatment. The company anticipates that further trials offer the potential for greater weight loss benefits over longer treatment periods or at higher doses.1
Last month, Viking also announced positive results from its Phase II VENTURE trial for VK2735. In this study, results show that after 13 weeks, there were weight reductions of up to 14.7% in baseline from participants who received weekly doses of the treatment. Investigators enrolled 176 adults who struggled with obesity or other weight-related conditions. There didn’t appear to be any plateau for weight loss at the end of the 13 weeks. Common AEs included gastrointestinal issues, nausea, vomiting, with one patient also experiencing dehyrdration.2
The findings of these trials are notable, as the experimental therapy could be an orally administered alternative to Eli Lilly’s injectable Zepbound and Novo Nordisk’s injectable Wegovy. However, VK2735 and Zepbound both imitate the naturally produced gut hormones GLP-1 and GIP, whereas Wegovy just targets GLP-1.
"We are excited to report the top-line results from this important Phase II study. VK2735 continues to demonstrate a promising efficacy and tolerability profile following 13 weeks of repeat dosing in obese subjects," said Lian, in a press release. "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. We look forward to progressing this important therapy into further clinical development later this year. Separately, we remain on track to report data from a Phase I study of an oral formulation of VK2735 later this quarter."