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    HP:0001397: Hepatic steatosis

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

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    Correlated Drug Terms (3)


    Name (Synonyms) Correlation
    drug166 AZD2693 Wiki 0.71
    drug3885 TERN-101 Wiki 0.71
    drug2916 Placebo Wiki 0.06

    Correlated MeSH Terms (4)


    Name (Synonyms) Correlation
    D065626 Non-alcoholic Fatty Liver Disease NIH 1.00
    D005234 Fatty Liver NIH 1.00
    D008659 Metabolic Diseases NIH 0.35
    Name (Synonyms) Correlation
    D050177 Overweight NIH 0.24

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There are 2 clinical trials


    1 A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2693 Following Single Ascending Dose Administration in Male and Female Subjects of Non-childbearing Potential in Overweight But Otherwise Healthy Subjects, and Healthy Chinese and Japanese Subjects

    This Phase 1, first-in-human (FiH), single-ascending-dose (SAD) study, will assess the safety and tolerability and characterize the pharmacokinetics (PK) of AZD2693, following subcutaneous (SC) SAD administration of AZD2693 in male and female subjects of non-childbearing potential in overweight but otherwise healthy subjects, and healthy Chinese and Japanese subjects.

    NCT04142424
    Conditions
    1. Metabolic Disorders
    2. Non-alcoholic Steatohepatitis
    Interventions
    1. Drug: AZD2693
    2. Drug: Placebo
    MeSH:Fatty Liver Non-alcoholic Fatty Liver Disease Metabolic Diseases Overweight
    HPO:Hepatic steatosis

    Primary Outcomes

    Description: To investigate the safety and tolerability of SC administration of SAD of AZD2693

    Measure: Number of subjects experiencing adverse events and serious adverse events

    Time: From baseline (Day 1) until Day 112 (Week 16, Final follow-up)

    Secondary Outcomes

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Area under the concentration-time curve from time zero extrapolated to infinity (AUC)

    Time: At Day 1 pre-dose, 0.25 hours [h], 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Area under the plasma concentration-time curve from time zero to 48 hours after dosing [AUC(0-48h)]

    Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D)

    Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast)

    Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUC/D)

    Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Maximum observed plasma drug concentration (Cmax) of AZD2693

    Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Observed maximum plasma concentration divided by the dose administered (Cmax/D)

    Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Time to reach maximum observed concentration following drug administration (tmax)

    Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693.

    Measure: Apparent terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic concentration-time curve, estimated as (ln2)/λz (t½λz)

    Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Apparent total body clearance of drug from plasma after extravascular administration calculated as Dose/AUC (CL/F)

    Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Apparent volume of distribution for parent drug at terminal phase (extravascular administration), estimated by dividing CL/F by λz (Vz/F)

    Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Mean residence time (MRT)

    Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Terminal elimination rate constant, estimated by log-linear least-squares regression of the terminal part of the concentration-time curve (λz)

    Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Time delay between drug administration and the first observed concentration in plasma (tlag)

    Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Time of the last quantifiable concentration (tlast)

    Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Cumulative fraction (%) of dose excreted unchanged into the urine from time zero to the last measured time point [fe(0-last)]

    Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Cumulative amount of analyte excreted into the urine from time zero through the last sampling interval [Ae(0-last)]

    Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Renal clearance of drug from plasma, estimated by dividing Ae(0-t) by AUC(0-t) where the 0-t interval is the same for both Ae and AUC [CLR]

    Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Amount of analyte excreted into the urine from time t1 to t2 [Ae(t1-t2)]

    Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-dose

    Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

    Measure: Fraction of dose excreted unchanged into the urine from time t1 to t2 [fe(t1-t2)]

    Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-dose
    2 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered TERN-101 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)

    This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of TERN-101 in non-cirrhotic NASH patients.

    NCT04328077
    Conditions
    1. NASH - Nonalcoholic Steatohepatitis
    Interventions
    1. Drug: TERN-101
    2. Other: Placebo
    MeSH:Fatty Liver Non-alcoholic Fatty Liver Disease
    HPO:Hepatic steatosis

    Primary Outcomes

    Measure: Subject incidence of adverse events for TERN-101 versus placebo

    Time: 16 weeks

    Secondary Outcomes

    Measure: Percent change from baseline in ALT for TERN-101 versus placebo at 12 weeks

    Time: 12 weeks

    Description: Area under the curve

    Measure: Plasma concentration of TERN-101 - AUC

    Time: 12 weeks

    Description: Maximum observed concentration

    Measure: Plasma concentration of TERN-101 - Cmax

    Time: 12 weeks

    Description: Time to reach maximum measured plasma concentration

    Measure: Plasma concentration of TERN-101 - Tmax

    Time: 12 weeks

    Description: Determination of half-life

    Measure: Plasma concentration of TERN-101 - t1/2

    Time: 12 weeks

    HPO Nodes


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    Data processed on September 26, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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