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RecruitingPhase 1

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of VK3019, an Amylin and Calcitonin Receptor Agonist, in Overweight and Obese Adults Without Comorbidities

Asset

VK3019

Subcutaneous · Amylin / calcitonin receptor agonist

Listed sites

1

Recruiting sites

1

Estimated enrollment

56

Study population

Obesity / overweight

Eligibility highlights

•BMI 27-40

Primary endpoint

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

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07846033
Org study IDVK3019-101

Timeline

Milestones

Study start2026-07-06actual
Study first posted2026-09-29actual
Last update posted2026-09-29actual
Primary completion2026-10-02estimated
Study completion2026-11estimated (month precision)

Assets

Investigational agents

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot 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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Evaluate the safety of single doses of subcutaneous administration of VK3019

Time frame:36 days

ratio, event

Secondary/protocol endpoint

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

Time frame:36 days

ratio, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.