Viking Therapeutics Oral Antiobesity Agent Returns Positive Results in Small Study
The once daily tablet, VK2375, is headed to a phase 2 trial later this year and is an oral version of Viking's investigational injectable GLP-1/GIP mimetic currently in phase 2.
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Viking Therapeutics announced positive weight loss findings from the phase 1 multiple ascending dose trial of an oral tablet formulation of VK2735, a dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist the company is developing for treatment of metabolic disorders, including obesity.
The results follow topline findings published in February from the company’s phase 2 VENTURE clinical trial program that is exploring a once-weekly injectable formulation of VK2735 for htt. The current study is an extension of the early single ascending dose iteration of that trial.
The small placebo-controlled trial evaluated the safety and tolerability of VK2735 administered orally once daily for 28 days. Clinical activity of 5 doses was investigated: 2.5 mg, 5 mg, 10 mg, 20 mg, and 40 mg, according to the company announcement. All participants enrolled had a baseline body mass index (BMI) of 30 mg/m2 or greater. Researchers observed dose-dependent reductions in mean body weight from baseline that reached 5.3% and reductions relative to placebo, ranging up to 3.3%.
The company also reported that for doses of 10 mg or more, placebo-adjusted reductions in mean body weight were either maintained or improved at study day 34, six days after the last dose of VK2735. Compared with placebo those reductions ranged up to 3.6%, said Viking. The study included an exploratory assessment of the proportion of participants that achieved weight loss of 5% or more of baseline body weight after 28 days of treatment and said that up to 57% of participants treated with VK2735 reached that target compared with none of those receiving placebo.
After a preliminary evaluation of the weight loss trajectory seen in the trial, Viking suggested that treatment beyond 28 days “may provide” further reductions in body weight.
Adverse events were GI related, reported as mild or moderate, and observed at a low rate, according to the release. Overall, there were no clinically meaningful differences reported for GI-related adverse events between VK2735- and placebo-treated participants, Viking said.
"These Phase 1 results highlight VK2735's promising early weight loss and tolerability profile when dosed as an oral tablet," Brian Lian, PhD, chief executive officer of Viking said in the 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.”
The oral formulation combined with good tolerability could be an “attractive” option for individuals with obesity, he said. “We look forward to exploring longer treatment windows and potentially higher doses in an upcoming Phase 2 trial."
Currently Viking plans to begin phase 2 trials in obesity in the second half of the year.
