VK3019 in overweight and obese adults without other health conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose study to characterize safety, tolerability, pharmacodynamics and pharmacokinetics of VK3019. Approximately 56 participants will be enrolled across 7 cohorts, with 8 per cohort, receiving VK3019 or matching placebo in a 6:2 ratio. Sentinel dosing occurs in each cohort to assess safety before expanding to the rest of the cohort, and dose escalation decisions are reviewed by a Safety Review Committee. The study uses subcutaneous VK3019 with appropriate monitoring and follow-up to characterize initial human exposure in overweight and obese adults without comorbidities.

Why it matters

Who can join: the full rules

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.

Where it's running

• Viking Clinical Site #001
  Lake Forest, California, United States Recruiting

Study contacts

• Study coordinator: Hubert C Chen, MD
• Email: clinicaltrials@vikingtherapeutics.com
• Phone: 8587044660

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.