Status:
COMPLETED
Phase 1 Study to Evaluate the Safety and Tolerability of VK2735
Lead Sponsor:
Viking Therapeutics, Inc.
Conditions:
Weight Loss
NASH
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VK273...
Detailed Description
This study comprises 3 parts: Part A (Single Ascending Dose \[SAD\]) will be conducted to assess the safety, tolerability, and PK profile in healthy participants following 1 single SC injection of VK...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT05203237
Start Date
December 14 2021
End Date
December 3 2024
Last Update
February 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Viking Clinical Site
Adelaide, South Australia, Australia, 5000