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RecruitingPhase 1

A Phase 1 Study of VK2735 in Obese Adults Without Comorbidities

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VK2735 Administration in Adults Who Are Obese (BMI ≥ 30 kg/m2) 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

  • Time periods mentioned: 21 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Each study part is comprised of treatment periods 1 and 2, lasting 21 weeks and 12 weeks, respectively."
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 early study tests the safety of VK2735 and how well people can handle it. It also looks at how the drug moves through and affects the body, compared with a placebo (a treatment with no active drug). It is for adults with obesity who are otherwise healthy.

The goal of this Phase 1, randomized, double-blind, placebo-controlled study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VK2735 in adults who are obese (BMI ≥ 30 kg/m2) 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 understand and sign a form agreeing to join the study.
  • Are medically healthy, with no major health history or important problems found during the study doctor's exam.
  • Have a body mass index (BMI) of 30 or higher. 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 may affect how the body takes in, moves, breaks down, or removes the study drug.
  • Have any condition that the study team thinks could make the study unsafe or affect its results.
  • Have or have had a serious sudden or unstable illness that the study doctor thinks poses a major risk. This includes stroke, cancer, or problems with the liver, kidneys, gut, lungs, immune system, hormones, blood, brain, or spinal cord.
  • Have or have had diabetes, including type 1 or type 2. Diabetes only during pregnancy is not excluded by this rule.
  • Have a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer), or have MEN-2 (a condition that can cause tumors in hormone-making glands).
  • Have ALT or AST liver blood test results more than 3 times the upper normal limit.
  • Have an eGFR below 60 at screening. This blood test estimate shows how well the kidneys filter blood.

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

Official eligibility criteria

Inclusion Criteria: * Must be capable of giving a signed informed consent form (ICF). * 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 study Investigator. * BMI ≥ 30 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. * Any condition that might compromise safety or other endpoints in the study as judged by the Sponsor (or designee) or Investigator. * History or presence of clinically significant acute or unstable cerebrovascular (stroke), hepatic, renal, gastrointestinal, pulmonary, immunological, endocrine, hematological, oncological, or central nervous disorder that in the opinion of the Investigator would pose a significant risk for the participant. * Current or past diagnosis of diabetes mellitus (including type 1 and type 2, except gestational diabetes). * Have a personal or family history of medullary thyroid carcinoma (MTC) or have multiple endocrine neoplasia syndrome type 2 (MEN-2). * Alanine aminotransferase (ALT) level or aspartate transaminase (AST) level \> 3.0 times the ULN for the reference range. * Impaired renal function with estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 as measured at Screening.

Study sites (2)

CA

FL