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NCT07846033PHASE1Recruiting

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

Viking Therapeutics, Inc.

Start Date

7/6/2026

Completion Date

11/1/2026

Summary

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to 60 years

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 organ system dysfunction as identified during physical examination, medical history or laboratory testing, as assessed by the Investigator. * Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption. * History or presence of clinically significant acute or unstable cerebrovascular (stroke), hepatic, renal, gastrointestinal, pulmonary, immunological, endocrine, diabetes, hematological, oncological, or central nervous disorder that in the opinion of the Investigator would pose a significant risk for the participant. * Current or prior diagnosis of diabetes mellitus (including type 1, type 2, except gestational diabetes). * History of, or current, clinically significant liver disease, gallbladder disease (with the exception of Gilbert's Syndrome), as assessed by the Investigator. * History of drug or alcohol abuse (ie, \>14 drinks/week for women or 21 drinks/week for men \[1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor\]) within 12 months of Screening.

Interventions

DRUG

SC VK3019

DRUG

Matching placebo

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Conditions

Obese Adults

Locations

Viking Clinical Site #001

Lake Forest, California 92630

United States