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Phase 1 Study to Evaluate the Safety and Tolerability of VK2735

PHASE1RECRUITING

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).

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Study details:

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 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).

Part C (Multiple Ascending Dose \[MAD\], PO) will be conducted to assess the safety, tolerability, PK and PD profiles in otherwise healthy, but obese, participants who have a BMI ≥30 kg/m2 following daily oral administration of VK2735 or matched placebo administered for 28 consecutive days (MAD-PO Cohort 1 through MAD-PO Cohort 4, with optional additional cohorts). Safety Review Committee (SRC) meetings will be held prior to dose escalation for Part A (SAD), Part B (MAD), and Part C (MAD-PO) cohorts in the study. The decisions on dose escalation will be based on safety and laboratory data from each cohort.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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 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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : Yes

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2021-12-14

    Primary completion: 2023-11-01

    Study completion finish: 2023-12-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

    trial

    Trial ID

    NCT05203237

    Intervention or treatment

    BIOLOGICAL: VK2735

    BIOLOGICAL: Placebo

    DRUG: VK2735 Placebo

    DRUG: VK2735 Drug

    Conditions

    • NASH
    • Weight Loss

    Find a site

    Closest Location:

    Viking Clinical Site

    Research sites nearby

    Select from list below to view details:

    • Viking Clinical Site

      Adelaide, South Australia, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    PLACEBO_COMPARATOR: Placebo (Part A)
    • Placebo administered SC once in healthy participants
    BIOLOGICAL: Placebo
    • Administered SC
    EXPERIMENTAL: VK2735 (Part A)
    • Escalating doses of VK2735 administered subcutaneously (SC) once in healthy participants.
    BIOLOGICAL: VK2735
    • Administered SC
    PLACEBO_COMPARATOR: Placebo (Part B)
    • Placebo administered SC once weekly for four weeks in healthy participants
    BIOLOGICAL: Placebo
    • Administered SC
    EXPERIMENTAL: VK2735 (Part B)
    • Escalating doses of VK2735 administered subcutaneously (SC) once weekly in healthy participants.
    BIOLOGICAL: VK2735
    • Administered SC
    PLACEBO_COMPARATOR: VK2735 (Part C )
    • Placebo administered orally daily for 28 days in healthy participants
    DRUG: VK2735 Placebo
    • Administered orally
    EXPERIMENTAL: VK2735 (Part C)
    • Escalating doses of VK2735 administered daily (PO) in healthy participants.
    DRUG: VK2735 Drug
    • Administered orally

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious AEs (TESAEs)To evaluate the safety and tolerability of single doses of subcutaneous injections of VK2735 in healthy participants8 days

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Evaluate the Pharmacokinetic profile of VK2735Pharmacokinetic profile of VK2735 by measuring peak plasma concentration (Cmax)29 days

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Phase 1 Study to Evaluate the Safety and Tolerability of VK2735

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