A Phase 1 Study of VK2735 in Obese Adults Without Comorbidities

Más betegség

• 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).

Laborértékek

• 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.
• 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.

• 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.