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NCT04483947 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess Safety, Tolerability, PK and PD of AZD2693 in Non-alcoholic Steatohepatitis Patients

A Phase 1 study of Non-alcoholic Steatohepatitis (NASH), sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
74
Enrollment target
16
Study locations

NCT04483947 is a Phase 1 study of Non-alcoholic Steatohepatitis (NASH) that has completed, run by AstraZeneca. The registered enrollment target is 74 participants, below the 163-participant average among 8 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (55% lower). The trial reports 16 study locations across 7 states.

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The verdict

NCT04483947, a Phase 1 study of Non-alcoholic Steatohepatitis (NASH), has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 1
Development phase
74 participants
Enrollment target
16
Study locations

Study Summary

This study is intended to investigate the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD2693, following subcutaneous (SC) administration of multiple ascending doses in participants with Non-alcoholic Steatohepatitis (NASH) with fibrosis Stage 0 to 3 and who are carriers of the patatin-like phospholipase domain-containing 3 (PNPLA3) 148M risk alleles.

Conditions Studied

Non-alcoholic Steatohepatitis (NASH)

Interventions

  • OTHER Placebo
  • DRUG AZD2693

Study Locations (16)

California

  • Research Site - Chula Vista
  • Research Site - La Mesa
  • Research Site - Montclair
  • Research Site - San Diego

Florida

  • Research Site - Doral
  • Research Site - Hialeah
  • Research Site - Hialeah
  • Research Site - Miami Lakes

Texas

  • Research Site - Arlington
  • Research Site - Dallas
  • Research Site - San Antonio
  • Research Site - San Antonio

Indiana

  • Research Site - Indianapolis

North Carolina

  • Research Site - Morehead City

Ohio

  • Research Site - Columbus

Pennsylvania

  • Research Site - Hershey

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2020-11-06
Est. Completion 2023-12-18
Phase Phase 1

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04483947

The ClinicalTrials.gov registry entry for NCT04483947 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 163-participant average among 8 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (55% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-alcoholic Steatohepatitis (NASH) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04483947 reports 16 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Texas.

Frequently Asked Questions

What is clinical trial NCT04483947 about?

NCT04483947 is a clinical study titled "A Study to Assess Safety, Tolerability, PK and PD of AZD2693 in Non-alcoholic Steatohepatitis Patients". This study is intended to investigate the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD2693, following subcutaneous (SC) administration of multiple ascending doses in participants with Non-alcoholic Steatohepatitis (NASH) with fibrosis Stage 0 to 3 and who are carri...

What is the current status of trial NCT04483947?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2020-11-06. Estimated completion is 2023-12-18.

What conditions does trial NCT04483947 study?

This clinical trial studies the following conditions: Non-alcoholic Steatohepatitis (NASH).

What interventions are being tested in trial NCT04483947?

The interventions under investigation include: Placebo (OTHER), AZD2693 (DRUG).

Who is sponsoring clinical trial NCT04483947?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04483947 being conducted?

This trial has 16 study locations across California, Florida, Indiana, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.