Viking Therapeutics (VKTX) Study result summary

Study design and objectives

• Randomized, double-blind, placebo-controlled trial in approximately 180 adults with obesity (BMI ≥30 kg/m²), using weekly, every-other-week, and monthly dosing regimens after a 21-week induction period.

• Induction doses ranged from 15 mg to 22.5 mg weekly or placebo, followed by a 12-week maintenance phase with flexible dosing or placebo.

• Objectives included evaluating safety, tolerability, pharmacokinetics, and weight change under various dosing regimens.

• Exploratory endpoints included changes in body weight from baseline and during maintenance, informing future phase III extension studies.

• The study aimed to provide flexible, less frequent dosing options for long-term weight loss maintenance.

Efficacy and weight loss results

• VK2735-treated subjects achieved 16–19% weight loss at week 21 versus 0% for placebo, with all doses significantly outperforming placebo (p<0.0001).

• 98% of treated subjects achieved ≥5% weight loss, 90% ≥10%, 65% ≥15%, and 32% ≥20% at week 21, compared to 13% for ≥5% in placebo.

• At week 33, continued weekly dosing at 17.5 mg achieved up to 22% weight loss, with no plateau observed.

• Every-other-week dosing maintained up to 97% of initial weight loss at week 33, and monthly dosing maintained up to 90%, both significantly better than placebo (61% retention, p<0.01).

• VK2735's efficacy compares favorably to currently approved and investigational agents, with higher placebo-adjusted weight loss at 33 weeks.

Safety and tolerability

• Discontinuation rates due to adverse events were very low across all regimens, with most adverse events being mild or moderate.

• GI adverse events (nausea, vomiting, diarrhea, constipation) were consistent with prior studies and similar to placebo during maintenance, with slightly lower nausea and slightly higher vomiting rates.

• Every-other-week and monthly dosing regimens showed adverse event rates similar to placebo, indicating excellent tolerability.

• No incremental increase in GI adverse events was observed with less frequent dosing, even with rapid titration.

• The PK profile and extended half-life of VK2735 may contribute to its favorable tolerability and dosing flexibility.