A Phase 1 Study of VK2735 in Obese Adults Without Comorbidities

Approximately 270 participants will be enrolled across two study parts: Part A and Part B. A total of 18 treatment groups are planned. Part A contains Groups 1 to 12, and Part B contains Groups 13 to 18. Part A will be completed prior to the enrollment of Part B.

Participants in Part A will be randomized equally across 12 treatment arms to receive one of 11 VK2735 dose regimens or a matching placebo regimen. Participants in Part B will be randomized equally across 6 treatment arms to receive one of four VK2735 dose regimens or matching placebo regimen. Each study part is comprised of treatment periods 1 and 2, lasting 21 weeks and 12 weeks, respectively. Study participants may receive a different dosing frequency and/or route of administration between the two periods.

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.