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NCT05677867 · ClinicalTrials.gov registry record · Phase 1
A Study to Compare Two Different Forms of PF-07081532 in Adults Who Are Overweight or Obese
A Phase 1 study of Obesity and Overweight, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05677867: Completed Phase 1 study of Obesity and Overweight, sponsored by Pfizer.
NCT05677867 is a Phase 1 study of Obesity and Overweight that has completed, run by Pfizer. The registered enrollment target is 20 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05677867, a Phase 1 study of Obesity and Overweight, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to compare the amount of PF-07081532 in blood after taking two different forms of PF-07081532. This study is seeking participants who are at least 18 years of age and are overweight and/or obese. All study participants will receive a total of 2 single doses of this study medication in either form. Form A consists of a PF-07081532 20 mg immediate release tablet and a PF-07081532 60 mg immediate release tablet. Form B consists of a PF-07081532 80 mg immediate release tablet. Each single dose will be separated by a minimum of 6 days. The amount of PF-07081532 in the blood for 4 days after taking each single dose will be compared between the two different formulations of PF-07081532. The total time that participants will take part in this study is about 70 days. The first visit is a screening visit to ensure that participants are appropriately qualified for the study. This will occur up to 28 days before the first single dose. Participants will be admitted into the clinic one day prior to the first single dose and will remain in the clinic for a total of 11 days. The study team will phone the participants 28 to 35 days after the last dose of study medication.
Primary Outcome
AUCinf is the area under the concentration-time curve to infinity. AUCinf was calculated by AUClast + (Clast\*/kel), where Clast\* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
Conditions Studied
Interventions
- DRUG Formulation A (PF-07081532 20 mg plus 60 mg)
- DRUG Formulation B (PF-07081532 80 mg)
Study Locations (1)
Connecticut
- New Haven Clinical Research Unit - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-01-18 |
| Est. Completion | 2023-03-14 |
| Phase | Phase 1 |
What the finished NCT05677867 record still lists
NCT05677867 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Formulation A (PF-07081532 20 mg plus 60 mg) is the first listed.
NCT05677867 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT05677867 about?
NCT05677867 is a clinical study titled "A Study to Compare Two Different Forms of PF-07081532 in Adults Who Are Overweight or Obese". The purpose of this study is to compare the amount of PF-07081532 in blood after taking two different forms of PF-07081532. This study is seeking participants who are at least 18 years of age and are overweight and/or obese. All study participants will receive a total of 2 single doses of this study...
What is the current status of trial NCT05677867?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-01-18. Estimated completion is 2023-03-14.
What conditions does trial NCT05677867 study?
This clinical trial studies the following conditions: Obesity, Overweight.
What interventions are being tested in trial NCT05677867?
The interventions under investigation include: Formulation A (PF-07081532 20 mg plus 60 mg) (DRUG), Formulation B (PF-07081532 80 mg) (DRUG).
Who is sponsoring clinical trial NCT05677867?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05677867 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05677867's enrollment target sits among peer trials
20 946th of 1053 higher than 80 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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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