NCT07846033 A Phase 1 Study of VK3019 in Overweight and Obese Adults Without Comorbidities

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 56 participants in total. It began in 2026-07-06 with a primary completion date of 2026-10-02.

Brief 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.

Eligibility Criteria

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.

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