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A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.

NCT04019561 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2023-01-17

Study results available
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Summary

A Phase 2 study with 4 treatment groups of two differing doses and matched placebos designed to evaluate the safety (including hepatic safety), tolerability and pharmacodynamic effects of two dose levels of MEDI0382 in obese subjects with non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH). The subjects will have biopsy-confirmed NAFLD/NASH with liver fibrosis stage F1, F2 or F3. Approximately 72 subjects will be randomized

Conditions

  • Non-alcoholic Fatty Liver Disease (NAFLD)
  • Non-alcoholic Steatohepatitis (NASH)

Interventions

DRUG

MEDI0382 high dose

MEDI0382 high dose administered subcutaneously

DRUG

Placebo for MEDI0382 high dose

Placebo for MEDI0382 high dose administered subcutaneously

DRUG

MEDI0382 low dose

MEDI0382 low dose administered subcutaneously

DRUG

Placebo for MEDI0382 low dose

Placebo for MEDI0382 low dose administered subcutaneously

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
101 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-23
Primary Completion
2021-05-06
Completion
2021-05-06
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04019561 on ClinicalTrials.gov