A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.
Public ClinicalTrials.gov record NCT04019561. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacodynamic Effects of MEDI0382 in Obese Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)/ Non-Alcoholic Steatohepatitis (NASH)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04019561
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 74 participants
Conditions and interventions
Interventions
- MEDI0382 high dose Drug
- Placebo for MEDI0382 high dose Drug
- MEDI0382 low dose Drug
- Placebo for MEDI0382 low dose Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 101 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 22, 2019
- Primary completion
- May 5, 2021
- Completion
- May 5, 2021
- Last update posted
- Jan 16, 2023
2019 – 2021
United States locations
- U.S. sites
- 26
- U.S. states
- 10
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Tucson | Arizona | 85712 | — |
| Research Site | Canoga Park | California | 91303 | — |
| Research Site | Chula Vista | California | 91911 | — |
| Research Site | Coronado | California | 92118 | — |
| Research Site | La Jolla | California | 92093 | — |
| Research Site | Lincoln | California | 95648 | — |
| Research Site | Los Angeles | California | 90057 | — |
| Research Site | Montclair | California | 91763 | — |
| Research Site | Torrance | California | 90505 | — |
| Research Site | Westminster | California | 92683 | — |
| Research Site | Doral | Florida | 33166 | — |
| Research Site | Hialeah | Florida | 33016 | — |
| Research Site | Miami | Florida | 33125 | — |
| Research Site | Miami | Florida | 33189 | — |
| Research Site | Palmetto Bay | Florida | 33157 | — |
| Research Site | Marrero | Louisiana | 70072 | — |
| Research Site | Las Vegas | Nevada | 89104 | — |
| Research Site | Las Vegas | Nevada | 89109 | — |
| Research Site | Durham | North Carolina | 27705 | — |
| Research Site | Blue Ash | Ohio | 45242 | — |
| Research Site | Chattanooga | Tennessee | 37421 | — |
| Research Site | Houston | Texas | 77002 | — |
| Research Site | Houston | Texas | 77084 | — |
| Research Site | San Antonio | Texas | 78215 | — |
| Research Site | San Antonio | Texas | 78229 | — |
| Research Site | Richmond | Virginia | 23219 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04019561, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 16, 2023 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04019561 live on ClinicalTrials.gov.