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Clinical Trial 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 VK2735 in healthy adults and otherwise healthy adults who have an increased body mass index (BMI).

Clinical Trial Description

This study comprises 2 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 VK2735 or VK2735 matching placebo (SAD Cohort 1 through SAD Cohort 6). Part B (Multiple Ascending Dose [MAD]) will be conducted to assess the safety, tolerability, PK and PD profile in otherwise healthy participants who have an increased BMI following single SC injections of VK2735 or matched placebo administered once weekly for 4 consecutive weeks (MAD Cohort 1 through MAD Cohort 5). Safety Review Committee (SRC) meetings will be held prior to dose escalation for both the Part A (SAD) and Part B (MAD) cohorts in the study. The decisions on dose escalation will be based on safety and laboratory data from each cohort. ;

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • NASH - Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease

NCT number NCT05203237
Study type Interventional
Source Viking Therapeutics, Inc.
Contact Marianne Mancini
Phone 858-704-4674
Email [email protected]
Status Recruiting
Phase Phase 1
Start date December 14, 2021
Completion date December 2022

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