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

NCT07846033 | Recruiting Phase 1 FDA Drug

• 1 other identifier: VK3019-101
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Keywords

Weight loss

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety of single doses of subcutaneous administration of VK3019

  -Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)

  36 days

Secondary Outcomes (1)

• Evaluate the Pharmacokinetic profile of single doses of subcutaneous administration of VK3019

  36 days

Study Arms (7)

VK3019 Dose Level 1

EXPERIMENTAL

Single-dose VK3019 or placebo administered subcutaneously

Drug: SC VK3019; Drug: Matching placebo

VK3019 Dose Level 2

EXPERIMENTAL

Single-dose VK3019 or placebo administered subcutaneously

Drug: SC VK3019; Drug: Matching placebo

VK3019 Dose Level 3

EXPERIMENTAL

Single-dose VK3019 or placebo administered subcutaneously

Drug: SC VK3019; Drug: Matching placebo

VK3019 Dose Level 4

EXPERIMENTAL

Single-dose VK3019 or placebo administered subcutaneously

Drug: SC VK3019; Drug: Matching placebo

VK3019 Dose Level 5

EXPERIMENTAL

Single-dose VK3019 or placebo administered subcutaneously

Drug: SC VK3019; Drug: Matching placebo

VK 3019 Dose Level 6

EXPERIMENTAL

Single-dose VK3019 or placebo administered subcutaneously

Drug: SC VK3019; Drug: Matching placebo

VK3019 Dose Level 7

EXPERIMENTAL

Single-dose VK3019 or placebo administered subcutaneously

Drug: SC VK3019; Drug: Matching placebo

Interventions

SC VK3019 DRUG

Single dose VK3019

VK 3019 Dose Level 6; VK3019 Dose Level 1; VK3019 Dose Level 2; VK3019 Dose Level 3; VK3019 Dose Level 4; VK3019 Dose Level 5; VK3019 Dose Level 7

Matching placebo DRUG

Single dose matching placebo

VK 3019 Dose Level 6; VK3019 Dose Level 1; VK3019 Dose Level 2; VK3019 Dose Level 3; VK3019 Dose Level 4; VK3019 Dose Level 5; VK3019 Dose Level 7

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Viking Therapeutics, Inc.: lead

Study Sites (1)

Viking Clinical Site #001

Lake Forest, California, 92630, United States

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hubert C Chen, MD

CONTACT

8587044660; clinicaltrials@vikingtherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 29, 2026
• Study Start: July 6, 2026
• Primary Completion: October 2, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)