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NCT04019561 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.
A Phase 2 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
NCT04019561 is a Phase 2 study that has completed, run by MedImmune. The registered enrollment target is 74 participants.
The verdict
NCT04019561, a Phase 2 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
Study 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
Interventions
- DRUG MEDI0382 low dose
- DRUG MEDI0382 high dose
- DRUG Placebo for MEDI0382 high dose
- DRUG Placebo for MEDI0382 low dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2019-09-23 |
| Est. Completion | 2021-05-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04019561
The ClinicalTrials.gov registry entry for NCT04019561 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MedImmune, which has 210 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which MEDI0382 low dose is the first listed.
NCT04019561 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04019561 about?
NCT04019561 is a clinical study titled "A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.". 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 steat...
What is the current status of trial NCT04019561?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2019-09-23. Estimated completion is 2021-05-06.
What interventions are being tested in trial NCT04019561?
The interventions under investigation include: MEDI0382 low dose (DRUG), MEDI0382 high dose (DRUG), Placebo for MEDI0382 high dose (DRUG), Placebo for MEDI0382 low dose (DRUG).
Who is sponsoring clinical trial NCT04019561?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
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