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NCT03625778 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of MEDI0382 in Non-diabetic Obese Participants
A Phase 1 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT03625778: Completed Phase 1 study, sponsored by MedImmune.
NCT03625778 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03625778, a Phase 1 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
This is a Phase 1, randomized, blinded, placebo-controlled study in up to approximately 51 non-diabetic obese participants with a body mass index (BMI) ≥ 35 kg/m\^2. The participants will be observed among 3 separate cohorts and participate in the study for up to approximately 27 weeks, including a screening period (including a run-in), treatment period, and safety follow-up.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at
Interventions
- DRUG Placebo
- DRUG MEDI0382
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2018-08-14 |
| Est. Completion | 2019-08-25 |
| Phase | Phase 1 |
What the finished NCT03625778 record still lists
NCT03625778 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03625778 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03625778 about?
NCT03625778 is a clinical study titled "A Study to Assess Safety, Tolerability, and Pharmacokinetics of MEDI0382 in Non-diabetic Obese Participants". This is a Phase 1, randomized, blinded, placebo-controlled study in up to approximately 51 non-diabetic obese participants with a body mass index (BMI) ≥ 35 kg/m\^2. The participants will be observed among 3 separate cohorts and participate in the study for up to approximately 27 weeks, including a ...
What is the current status of trial NCT03625778?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2018-08-14. Estimated completion is 2019-08-25.
What interventions are being tested in trial NCT03625778?
The interventions under investigation include: Placebo (DRUG), MEDI0382 (DRUG).
Who is sponsoring clinical trial NCT03625778?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03625778's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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