Health TrialsbyHealthPanel

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

ConditionObese Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorViking Therapeutics, Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Sequential

Treatments tested in this trial

  • SC VK3019

    Drug

    Single dose VK3019

  • Matching placebo

    Drug

    Single dose matching placebo

Treatment groups

56 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: VK3019 Dose Level 1Experimental treatment 2 interventions
Group B: VK3019 Dose Level 2Experimental treatment 2 interventions
Group C: VK3019 Dose Level 3Experimental treatment 2 interventions
Group D: VK3019 Dose Level 4Experimental treatment 2 interventions
Group E: VK3019 Dose Level 5Experimental treatment 2 interventions
Group F: VK 3019 Dose Level 6Experimental treatment 2 interventions
Group G: VK3019 Dose Level 7Experimental treatment 2 interventions

Trial outcomes

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)

Time frame
36 days

Secondary outcomes

1

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

Pharmacokinetic profile of subcutaneous VK3019 by measuring peak plasma concentration (Cmax)

Time frame
36 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Viking Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now