VKTX- Viking Therapeutics Announces Completion of Enrollment in Phase 2 VENTURE Trial of Dual GLP-1/GIP Receptor Agonist VK2735 in Patients with Obesity. This is a phase 2 trial of the SubQ version of VK2735 (there is also an ongoing phase 1 trial of the oral version of this compound)
Trial Size Increased from 125 to 176 Patients Due to Elevated Demand
13-Week Study to Evaluate the Safety and Efficacy of VK2735 Dosed Weekly
The VENTURE trial will evaluate weekly VK2735 doses of up to 15 mg, compared to the 10 mg top dose evaluated in the prior Phase 1 multiple ascending dose (MAD) study.
The increase of the top dosage is to 15mg matches the top dose for Mounjaro studied in the SURMOUNT-2 trail. Management must have high confidence in the efficacy of VK2735 drug to make this only a 13-week study. Personally, I would have liked to see a longer duration (e.g.-24-26 weeks.)
As a reference point when LLY did their SURMOUNT-2 phase 3 study for Mounjaro (tirzepatide) they went 72 weeks to get 15.7% weight loss (34.4lb. or 15.6 kg) on 15 mg compared to placebo (3.3%, 7.0 lb. or 3.2 kg) As another comparison in a phase 2 study for LLY's retatrutide (LLY's "triple g") got 16% weight loss at 24 weeks and the extended data at 48 weeks showed 24% weight loss. Retatrutide is currently touted as a potential "best in class" weight loss drug.
Also in the press release Viking re-iterated info from the prior phase 1 study:
Viking previously reported positive results from a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of VK2735 in healthy volunteers with a BMI ≥30. In the SAD portion of the study, VK2735 demonstrated promising safety and tolerability, as well as a predictable pharmacokinetic profile. In the 28-day MAD portion of the study, VK2735 experienced reductions in mean body weight from baseline, ranging up to 7.8%.Cohorts receiving VK2735 also demonstrated reductions in mean body weight relative to placebo, ranging up to 6.0%. Statistically significant differences compared to placebo were maintained or improved at the Day 43 follow-up time point, 21 days after the last dose of VK2735 was administered.
The majority of observed adverse events (98%) in the Phase 1 trial were reported as mild or moderate. The company believes that the tolerability data from the Phase 1 study indicate that higher doses may be achieved with longer titration windows.
These results were featured earlier this month in an oral presentation at ObesityWeek® 2023, the annual meeting of the Obesity Society. The presentation highlighted the previously-reported safety, tolerability, and weight loss findings, as well as new data demonstrating VK2735's impact on liver fat and plasma lipids. Notably, after four weekly doses of VK2735, subjects in the Phase 1 trial reported liver fat reductions of up to 47% from baseline (placebo-adjusted, p<0.01). Among subjects with non-alcoholic fatty liver disease (NAFLD), placebo-adjusted reductions in liver fat reached approximately 59% (p<0.01). Though limited in sample size, these results may indicate VK2735's potential benefit in patients with various forms of fatty liver disease.
The Obesity Week presentation also highlighted VK2735's effects on plasma lipids. Despite normal baseline plasma lipid levels among these healthy volunteers, treatment with VK2735 produced encouraging reductions from baseline in total cholesterol (up to 21%), low-density lipoprotein cholesterol (LDL-C; up to 23%), and apolipoprotein B [Apo(B); up to 21%].
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