VK3019A Phase 1 Study of VK3019 in Overweight and Obese Adults Without Comorbidities

Sponsor:

Viking Therapeutics, Inc.

Code:

NCT07846033

Conditions

Obese Adults

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

SC VK3019

Matching placebo

Study Details

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.

Conditions

Obese Adults

Study ID

NCT07846033

Start date

Jul 6, 2026

Status verified date

Sep, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Oct 2, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment