A Phase 1 Study of VK3019 in Overweight and Obese Adults Without Comorbidities

Approximately 56 participants will enroll into one of 7 cohorts (Cohort 1 through Cohort 7 N=8 per cohort) and will receive either VK3019 or VK3019 matching placebo (for a total of 6 VK3019 and 2 placebo per cohort). All dose cohorts will first dose 2 sentinels (1 active and 1 placebo) to be followed by the rest of the cohort (ROC) no sooner than 48 hours following sentinel dosing. In all cohorts, the first 2 enrolled participants (sentinel pair) will be randomized in a 1:1 ratio and in a double-blind fashion, to receive either VK3019 or matching VK3019 placebo. The 2 sentinel participants will be dosed on the same day (Day 1). If deemed safe by the Investigator, a minimum 2 days after sentinel pair dosing, the same dose will be administered to the ROC participants. The rest of the participants within cohort will be randomized 5:1 where 1 is the remaining placebo. Safety Review Committee (SRC) meetings will be held prior to dose escalation during the study in a blinded fashion. The decisions on dose escalation will be based on safety and laboratory data from each cohort.