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

Viking Therapeutics, Inc.2 个研究点分布在 1 个国家目标入组 270 人开始时间: 2025年11月18日最近更新: 2026年9月24日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: Viking Therapeutics, Inc.
入组人数: 270
试验地点: 2
主要终点: Evaluate the Safety and Tolerability VK2735

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•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/m
•Willing to comply with contraceptive requirements.

排除标准

•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.

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo Subcutaneously (SC) weekly

干预措施: Placebo (Drug)

VK2735 Dose Level 2

Experimental

VK2735 subcutaneously weekly followed by Placebo subcutaneously weekly

干预措施: VK2735 Drug (Drug)

VK2735 Dose Level 2

Experimental

VK2735 subcutaneously weekly followed by Placebo subcutaneously weekly

干预措施: Placebo (Drug)

VK2735 Dose Level 3

Experimental

VK2735 subcutaneously weekly followed by VK2735 subcutaneously weekly

干预措施: VK2735 Drug (Drug)

VK2735 Dose Level 4

Experimental

VK2735 subcutaneously weekly followed by VK2735 subcutaneously every other week

干预措施: VK2735 Drug (Drug)