Viking Therapeutics Dual GIP/GLP-1 Mimetic Drives Weight Loss of Up to 14.7% in Phase 2 Findings
Viking's VENTURE trial met primary and all secondary endpoints, with GI-related TAEAs reported as mild/moderate and diminishing over the course of the 13-week study.
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Weight reduction of up to 14.7% from baseline among individuals with obesity/overweight leads topline findings from the phase 2 VENTURE clinical trial reported by Viking Therapeutics on Tuesday.
The company compared VK2735, an investigational dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) mimetic, administered subcutaneously once weekly over 13 weeks, with placebo and announced “robust” and early weight loss across all doses evaluated that were statistically significant from placebo at week 1 and continued through week 13, satisfying the study’s primary endpoint.
With no plateau of weight loss observed at week 13, Viking anticipates that “further weight loss might be achieved from extended dosing periods.”
The company also reported statistically significant differences for VK2735 compared with placebo on the study’s key secondary endpoint, which assessed the proportion of patients who achieved weight loss of at least 10%. Up to 88% of participants treated with the investigational compound reached weight loss of 10% or more while those who received placebo reached 4%, Viking stated in the announcement.
VENTURE was a phase 2 randomized, double-blind, placebo-controlled study launched to assess the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735. Investigators enrolled 176 adults with obesity (BMI ≥30 kg/m2), or adults with overweight (BMI ≥27 kg/m2) and at least one weight-related comorbid condition, according to the announcement. The trial’s primary endpoint was the assessment of the percent change in body weight from baseline to week 13 among VK2735-treated participants compared with those who received placebo. The secondary and exploratory endpoints evaluated outcomes of additional safety and efficacy measures.
Viking described safety and tolerability outcomes as “encouraging” after 13 weeks of once-weekly treatment with VK2735.
The treatment emergent adverse events (TEAEs) reported by the majority (92%) of VK2735 group participants were mild or moderate with gastrointestinal events most common (95%). Nausea (43% VK2735, 30% placebo) was also reported as moderate with no reports of severe symptoms. Fewer than 1 in 5 (18%) of those treated with the study drug reported vomiting; there were no reports of vomiting in the placebo group.
Importantly the company states that the GI-related events occurred early in treatment and decreased as dosing continued. Further, across all VK2735 dosing groups, the weekly rate of nausea did not exceed 5% after the first week of study treatment.
The rates of study discontinuation were “low and well balanced” among participants who received the active study drug compared with those treated with placebo, according to the announcement. One serious adverse event was reported in a single VK2735-treated participant, described as dehydration, and most likely related to the study drug.
“We look forward to progressing this important therapy into further clinical development later this year,” Brian Lian, PhD, Viking CEO said in the press statement. “ Separately, we remain on track to report data from a Phase 1 study of an oral formulation of VK2735 later this quarter."
