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NCT03654313 · ClinicalTrials.gov registry record · Phase 1
Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus
A Phase 1 study of Cardiovascular Disease and Atherosclerosis, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 88
- Enrollment target
- 9
- Study locations
NCT03654313: Completed Phase 1 study of Cardiovascular Disease and Atherosclerosis, sponsored by MedImmune.
NCT03654313 is a Phase 1 study of Cardiovascular Disease and Atherosclerosis that has completed, run by MedImmune. The registered enrollment target is 88 participants, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (97% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03654313, a Phase 1 study of Cardiovascular Disease and Atherosclerosis, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 88 participants
- Enrollment target
- 9
- Study locations
Study Summary
To evaluate the safety, tolerability, PK and immunogenicity of single and multiple ascending doses of MEDI6570 in subjects with Type 2 Diabetes Mellitus
Primary Outcome
Measured by the incidence of treatment- emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL MEDI6570
- BIOLOGICAL Part B Placebo
Study Locations (9)
Florida
- Research Site - Jacksonville
- Research Site - Miami
- Research Site - Port Orange
Alabama
- Research Site - Anniston
Hawaii
- Research Site - Honolulu
North Carolina
- Research Site - High Point
Ohio
- Research Site - Cincinnati
Tennessee
- Research Site - Knoxville
Texas
- Research Site - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2018-09-28 |
| Est. Completion | 2020-07-21 |
| Phase | Phase 1 |
What the finished NCT03654313 record still lists
NCT03654313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Cardiovascular Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03654313 lists 9 locations in 7 states (Florida, Alabama, Hawaii).
Frequently Asked Questions
What is clinical trial NCT03654313 about?
NCT03654313 is a clinical study titled "Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus". To evaluate the safety, tolerability, PK and immunogenicity of single and multiple ascending doses of MEDI6570 in subjects with Type 2 Diabetes Mellitus
What is the current status of trial NCT03654313?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2018-09-28. Estimated completion is 2020-07-21.
What conditions does trial NCT03654313 study?
This clinical trial studies the following conditions: Cardiovascular Disease, Atherosclerosis.
What interventions are being tested in trial NCT03654313?
The interventions under investigation include: Placebo (BIOLOGICAL), MEDI6570 (BIOLOGICAL), Part B Placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT03654313?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03654313 being conducted?
This trial has 9 study locations across Alabama, Florida, Hawaii, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cardiovascular Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03654313's enrollment target sits among peer trials
88 83rd of 137 higher than 55 of 137 other Cardiovascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Disease 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.
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