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NCT04305587 · ClinicalTrials.gov registry record · Phase 1
Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
A Phase 1 study of Diabetes Mellitus, Type 2, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 2
- Study locations
NCT04305587: Completed Phase 1 study of Diabetes Mellitus, Type 2, sponsored by Pfizer.
NCT04305587 is a Phase 1 study of Diabetes Mellitus, Type 2 that has completed, run by Pfizer. The registered enrollment target is 66 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04305587, a Phase 1 study of Diabetes Mellitus, Type 2, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open, dose-escalating study of PF-07081532 in patients with Type 2 diabetes on metformin (Parts A and C). The study may also enroll non-diabetic participants with obesity (Part B). Study participants will receive an investigational product or placebo every day for up to 28 days (Part A) or up to 42 days (Part B, optional; Part C, optional). The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of PF-07081532 in participants with inadequately controlled T2DM on metformin and optionally in non-diabetic obese participants.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an impo
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Clopidogrel
- DRUG PF-07081532
Study Locations (2)
California
- Anaheim Clinical Trials, LLC - Anaheim
Florida
- Qps-Mra, Llc - South Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2020-03-16 |
| Est. Completion | 2021-07-14 |
| Phase | Phase 1 |
What the finished NCT04305587 record still lists
NCT04305587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04305587 reports a single indexed study location in California, Florida.
Frequently Asked Questions
What is clinical trial NCT04305587 about?
NCT04305587 is a clinical study titled "Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus". This is a randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open, dose-escalating study of PF-07081532 in patients with Type 2 diabetes on metformin (Parts A and C). The study may also enroll non-diabetic participants with obesity (Part B). Study participa...
What is the current status of trial NCT04305587?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2020-03-16. Estimated completion is 2021-07-14.
What conditions does trial NCT04305587 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT04305587?
The interventions under investigation include: Placebo (OTHER), Clopidogrel (DRUG), PF-07081532 (DRUG).
Who is sponsoring clinical trial NCT04305587?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04305587 being conducted?
This trial has 2 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04305587's enrollment target sits among peer trials
66 231st of 348 higher than 115 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 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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