A Phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VK2735, a dual glucagon-like peptide-1 and gastric inhibitory polypeptide receptor agonist, in healthy adults and otherwise healthy adults who have an increased body mass index

Viking Therapeutics, Inc.0 个研究点目标入组 88 人开始时间: 2021年12月10日最近更新: 2023年1月9日

适应症

试验速览

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•1. Participants must be capable of giving signed informed consent
•2. 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
•3. Participant body weight must have been stable (no change greater than 5%) for a minimum 8 weeks prior to Screening
•4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical study procedures
•5. Willing to comply with contraception requirements

•1. Participants with any level of disease or organ system dysfunction as identified during physical examination, medical history or laboratory testing, as assessed by the PI
•2. Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption
•3. Participants may be excluded from the study if they have conditions that might compromise safety or other endpoints in the study as judged by the Sponsor (or designee) or Investigator
•4. 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
•5. Use of any investigational drug or product, or participation in an investigational drug study within 30 days prior to dosing or 5 half-lives of the drug (whichever is longest)
•6. Active smoker and/or user of nicotine-containing products unless the participant agrees to discontinue smoking/use of nicotine-containing products from 2 weeks before first IP dose administration through to study completion, including the follow-up period
•7. Have serum triglycerides >5.65 mmol/l (500 mg/dl) at Screening
•8. Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV

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