Non-alcoholic steatohepatitis (NASH) Digestive System Other specified inflammatory liver diseases
Conditions
Interventions
Approximately 48 Part A (SAD) participants will enroll into one of 6 SAD cohorts (SAD Cohort 1 through SAD Cohort 6, N = 8 per cohort) and will be randomized to receive either VK2735 (at doses: 0.25 m
Sponsors
Viking Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety measured as the incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious AEs (TESAEs) measured between baseline and 16 days for part A of the study, and between baseline and 43 days for part B of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma pharmacokinetic analysis of VK2735 measured using Cmax, Tmax, AUC, and other plasma PK analysis of VK2735 from blood samples taken between 30 min pre-dose and 168 h post-dose for part A and part B of the study | — |
Countries
Australia
Contacts
Public ContactMarianne Mancini
Outcome results
None listed