Viking Therapeutics, Inc.
This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics 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 wi…
Inclusion Criteria: * Must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF). * Participants must be medically healthy, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of the initial dose of IP in the opinion of the Investigator. * Body mass index ≥ 27 kg/m2 and \< 40 kg/m2. * Willing to comply with contraceptive requirements. Exclusion Criteria: * Participants with any level of disease or or…
Single dose VK3019
Single dose matching placebo
Arctuva estimate
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