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

Viking Therapeutics, Inc.1 个研究点分布在 1 个国家目标入组 56 人开始时间: 2026年7月6日最近更新: 2026年9月29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: 56
试验地点: 1
主要终点: Evaluate the safety of single doses of subcutaneous administration of VK3019

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

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.

详细描述

Approximately 56 participants will enroll into one of 7 cohorts (Cohort 1 through Cohort 7 N=8 per cohort) and will receive either VK3019 or VK3019 matching placebo (for a total of 6 VK3019 and 2 placebo per cohort).

All dose cohorts will first dose 2 sentinels (1 active and 1 placebo) to be followed by the rest of the cohort (ROC) no sooner than 48 hours following sentinel dosing. In all cohorts, the first 2 enrolled participants (sentinel pair) will be randomized in a 1:1 ratio and in a double-blind fashion, to receive either VK3019 or matching VK3019 placebo. The 2 sentinel participants will be dosed on the same day (Day 1). If deemed safe by the Investigator, a minimum 2 days after sentinel pair dosing, the same dose will be administered to the ROC participants. The rest of the participants within cohort will be randomized 5:1 where 1 is the remaining placebo.

Safety Review Committee (SRC) meetings will be held prior to dose escalation during the study in a blinded fashion. The decisions on dose escalation will be based on safety and laboratory data from each cohort.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
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 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/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.
•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.