Presentation Highlights Previously Reported Weight Loss of up to 7.8% From Baseline as well as Significant Liver Fat, Plasma Lipid Reductions following 28 Days of Treatment with VK2735
SAN DIEGO, Oct. 17, 2023 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that new results from the company's Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of VK2735 were featured in an oral presentation at ObesityWeek 2023, the annual meeting of The Obesity Society. VK2735 is a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors in development for the potential treatment of various metabolic disorders such as obesity.
Highlights from the oral presentation include newly reported data demonstrating that 28 days of once-weekly treatment with VK2735 resulted in reductions in subjects' liver fat content and plasma lipid levels, both from baseline and as compared to placebo.
Data presented at ObestityWeek 2023 include:
Reduction in Liver Fat Content
Following 28 days of once-weekly treatment with VK2735, study results demonstrated reductions in liver fat content, both as compared to baseline and as compared to placebo. Subjects receiving VK2735 experienced reductions in liver fat ranging up to 47.2% from baseline.
In the subgroup of study subjects with non-alcoholic fatty liver disease (NAFLD), defined as those with greater than 5% liver fat at baseline, the reductions in liver fat levels were more pronounced. For these subjects, reductions from baseline after four weekly doses ranged up to 49.7%, and placebo-adjusted reductions of up to 58.5% were reported. These results suggest that treatment with VK2735 may provide benefit among patients with NAFLD or non-alcoholic steatohepatitis (NASH).
Change in Liver Fat Content Following 28 Days of Dosing with VK2735
Multiple Ascending Dose Level | Placebo (n=8) | VK2735 0.5 mg (n=6) | VK2735 1.5 mg (n=6) | VK2735 1.5/3/5/5 mg2 (n=6) | VK2735 3/5/5/7.5 mg (n=6) | VK2735 5/5/7.5/10 mg (n=4) |
Mean baseline liver fat content (%)1 | 6.59 | 2.58 | 7.84 | 8.14 | 11.1 | 3.96 |
Mean percent change from baseline 3 | -0.7 | 3.9 | -24.2 | -24.0 | -47.2 | -8.4 |
p-value vs. placebo4 | - | 0.74 | 0.09 | 0.10 | 0.002 | 0.62 |
NAFLD subset | n=3 | n=0 | n=4 | n=4 | n=4 | n=1 |
Mean baseline liver fat content (%)1 | 12.7 | - | 10.6 | 10.6 | 15.2 | 7.7 |
Mean percent change from baseline 3 | 8.8 | - | -33.8 | -32.5 | -49.7 | -10.7 |
p-value vs. placebo4 | - | - | 0.03 | 0.03 | 0.006 | - |
Notes: 1) MRI-PDFF; all subjects enrolled in MAD portion of study were required to have baseline BMI ≥30 kg/m2. 2) Subjects received escalating weekly doses of 1.5 mg, 3.0 mg, 5.0 mg, 5.0 mg. 3) Least squares mean. 4) Two-sided t test using ANCOVA.
Reduction in Plasma Lipid Levels
Study investigators also evaluated the change in subjects' levels of plasma lipids, including apolipoprotein B (ApoB), low-density lipoprotein cholesterol (LDL-C), and total cholesterol, following 28 days of once-weekly treatment with VK2735. Dose dependent reductions from baseline in these plasma lipid levels were observed across VK2735 treatment cohorts after four weekly doses. No meaningful changes in levels of high-density lipoprotein cholesterol (HDL-C) were observed following treatment with VK2735.
Change in Plasma Lipids Following 28 Days of Dosing with VK2735
Multiple Ascending Dose Level | Placebo (n=9) | VK2735 0.5 mg (n=6) | VK2735 1.5 mg (n=6) | VK2735 1.5/3/5/5 mg2 (n=6) | VK2735 3/5/5/7.5 mg (n=6) | VK2735 5/5/7.5/10 mg (n=4) |
Mean change in Apo(B) from baseline (%)1 | 1.8 | 3.3 | -1.8 | -12.9 | -12.5* | -20.5 |
Mean change in LDL-C from baseline (%) | -9.5 | 1.4 | -10.6 | -13.7 | -20.3* | -23.0 |
Mean change in total cholesterol from baseline (%) | -5.1 | -1.7 | -10.8 | -14.9* | -17.4* | -21.0 |
Notes: *p