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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests single doses of VK3019 in overweight or obese adults who are otherwise healthy. It looks at safety, side effects, how the drug affects the body, and how the body handles it. Participants get either VK3019 or a placebo, which has no active drug.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can sign a consent form and follow the study rules.
  • Are medically healthy, with no major medical history or important problems found during a physical exam.
  • Have a body mass index (BMI) of at least 27 but less than 40. BMI is a measure based on height and weight.
  • Are willing to follow the study’s birth control rules.

Who can't join

  • Have any disease or problem with how an organ works, as judged by the study doctor.
  • Have a medical condition or past surgery that could affect how the body takes in, moves, breaks down, or removes the study drug.
  • Have or have had a serious sudden or unstable illness that the study doctor thinks would pose a major risk. This includes stroke or problems with the liver, kidneys, digestion, lungs, immune system, hormones, blood, cancer, or brain and nerves.
  • Have ever been diagnosed with diabetes, except diabetes during pregnancy.
  • Have or have had major liver or gallbladder disease, as judged by the study doctor. Gilbert’s syndrome is an exception.
  • Have a history of drug or alcohol abuse in the 12 months before screening. The listed alcohol limits are more than 14 drinks a week for women or 21 for men. One drink means 150 mL of wine, 360 mL of beer, or 45 mL of hard liquor.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

CA