Phase
Condition
Weight Loss
Diabetes Prevention
Liver Disease
Treatment
VK2735
Placebo
VK2735 Drug
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must be capable of giving signed informed consent
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
Participant body weight must have been stable (no change greater than 5%) for a minimum 8 weeks prior to Screening
Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical study procedures
Willing to comply with contraception requirements
Exclusion
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 PI
Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption
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
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
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)
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
Have serum triglycerides > 5.65 mmol/L (500 mg/dL) at Screening
Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV
Study Design
Study Description
Connect with a study center
Viking Clinical Site
Randwick, New South Wales 2031
AustraliaSite Not Available
Viking Clinical Site
Adelaide, South Australia 5000
AustraliaSite Not Available
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