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Formulation A (Reference) followed by Formulation B (Test) for Obesity

Phase 1

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (hour) 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, day 2 (hour) 24 and 36, day 3 (hour) 48, day 4 (hour) 72 and day 5 (hour) 96

Awards & highlights

Study Summary

This trial compares two forms of a drug to see how much of it is in the blood after taking it. Participants must be 18+, overweight/obese and have a 70-day study duration with 1st visit being a screening.

Eligible Conditions

Obesity

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (hour) 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, day 2 (hour) 24 and 36, day 3 (hour) 48, day 4 (hour) 72 and day 5 (hour) 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (hour) 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, day 2 (hour) 24 and 36, day 3 (hour) 48, day 4 (hour) 72 and day 5 (hour) 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (hour) 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, day 2 (hour) 24 and 36, day 3 (hour) 48, day 4 (hour) 72 and day 5 (hour) 96 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Formulations A and B

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Formulations A and B

Maximum Observed Plasma Concentration (Cmax) for Formulations A and B

Secondary outcome measures

Number of Participants Reporting Treatment-Emergent Adverse Events

Number of Participants with Abnormal Electrocardiogram (ECG)

Number of Participants with Clinical Laboratory Abnormalities

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Formulation B (Test) followed by Formulation A (Reference)Experimental Treatment2 Interventions

Group II: Formulation A (Reference) followed by Formulation B (Test)Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Formulation B (PF-07081532 80 mg)

2023

Completed Phase 1

~20

Formulation A (PF-07081532 20 mg plus 60 mg)

2023

Completed Phase 1

~20

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor

4,575 Previous Clinical Trials

10,923,081 Total Patients Enrolled

40 Trials studying Obesity

116,942 Patients Enrolled for Obesity

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,482 Previous Clinical Trials

8,099,343 Total Patients Enrolled

29 Trials studying Obesity

120,206 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree is Formulation B (Test) followed by Formulation A (Reference) considered safe for those participating?

"Due to the limited safety and efficacy data available, our team at Power rated Formulation B (Test) followed by Formulation A (Reference)'s safety on a scale of 1-3 as a 1."

Answered by AI

Are there any vacancies for individuals to join this experiment?

"The clinical trial is currently in the recruitment phase, as denoted by data posted on clinicaltrials.gov from January 18th to 25th 2023."

Answered by AI

What is the enrollment quota for this research study?

"Affirmative. According to the information present on clinicaltrials.gov, this trial is actively looking for volunteers and was initially posted on January 18th 2023 with a recent edit made on the 25th of that same month. To date, they are searching for 20 participants at 1 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Compare Two Different Forms of PF-07081532 in Adults Who Are Overweight or Obese

2023. "A Study to Compare Two Different Forms of PF-07081532 in Adults Who Are Overweight or Obese". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05677867.