Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04019561 | A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH. | PHASE2 | COMPLETED | 74 | — | — | Sep 23, 2019 | May 6, 2021 | Jan 17, 2023 | 27 | United States, Puerto Rico |
The number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE) through the end of the follow-up period
| Arm | Type | Description |
|---|---|---|
| MEDI0382 high dose | EXPERIMENTAL | MEDI0382 high dose administered subcutaneously |
| Placebo for MEDI0382 high dose | PLACEBO_COMPARATOR | Placebo for MEDI0382 high dose administered subcutaneously |
| MEDI0382 low dose | EXPERIMENTAL | MEDI0382 low dose administered subcutaneoously |
| Placebo for MEDI0382 low dose | PLACEBO_COMPARATOR | Placebo for MEDI0382 low dose administered subcutaneously |
| Name | Type | Description |
|---|---|---|
| MEDI0382 high dose | DRUG | MEDI0382 high dose administered subcutaneously |
| Placebo for MEDI0382 high dose | DRUG | Placebo for MEDI0382 high dose administered subcutaneously |
| MEDI0382 low dose | DRUG | MEDI0382 low dose administered subcutaneously |
| Placebo for MEDI0382 low dose | DRUG | Placebo for MEDI0382 low dose administered subcutaneously |
Inclusion Criteria: 1. Provision of informed consent (with the exception of consent for future genetic and non genetic research) prior to performing any study-specific procedures, including screening evaluations. 2. Subjects aged ≥ 18 years at the time of consent. 3. Body mass index ≥ 30 kg/m2 at s...