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Cohort 1: PF-07081532 for Obesity

Anaheim Clinical Trials, LLC, Anaheim, CA
ObesityPF-07081532 - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial will study the effects of GLP-1 drugs on the blood levels of 3 common medications. The hypothesis is that their effects will be minimal.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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1
Cohort 1
1
Period 2: Cyclosporine + PF-07081532
1
INDV-2000 BID + Midazolam

Study Objectives

4 Primary · 27 Secondary · Reporting Duration: , 0.75, 2, 4, 8, 12, 24, 48, 72, 96, and 120 hours post dose in Periods 2, 5, and 8 for Cohort 1

Hour 120
Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUClast) for levonorgestrel and ethinyl estradiol.
Hour 24
Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf) for midazolam.
Hour 24
Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUClast) for midazolam.
Hour 24
Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf) for midazolam
Hour 24
Apparent Oral Clearance (CL/F) for midazolam.
Maximum observed plasma concentration (Cmax) for midazolam.
Metabolite/parent ratio for midazolam (MRAUCinf [1-hydroxymidazolam AUCinf/midazolam AUCinf])
Plasma Elimination Half-Life (t1/2) for midazolam.
Time to Reach Maximum Observed Plasma Concentration (Tmax) for midazolam.
Hour 24
Time to Reach Maximum Observed Plasma Concentration (Tmax) for midazolam and omeprazole.
Hour 24
Apparent Oral Clearance (CL/F) for midazolam and omeprazole.
Apparent Volume of Distribution (Vz/F) for midazolam and omeprazole.
Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf) for midazolam and omeprazole.
Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUClast) for midazolam and omeprazole.
Maximum observed plasma concentration (Cmax) for midazolam and omeprazole.
Metabolite/parent ratio for omeprazole (MRAUCinf [5-hydroxyomeprazole AUCinf/omeprazole AUCinf])
Plasma Elimination Half-Life (t1/2) for midazolam and omeprazole.
Day 63
Area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) for PF-07081532.
Maximum observed plasma concentration (Cmax) for PF-07081532
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-07081532.
Hour 120
Apparent Oral Clearance (CL/F) for levonorgestrel and ethinyl estradiol
Apparent Volume of Distribution (Vz/F) for levonorgestrel and ethinyl estradiol.
Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf) for levonorgestrel and ethinyl estradiol.
Maximum observed plasma concentration (Cmax) for levonorgestrel and ethinyl estradiol.
Plasma Elimination Half-Life (t1/2) for levonorgestrel and ethinyl estradiol.
Time to Reach Maximum Observed Plasma Concentration (Tmax) for levonorgestrel and ethinyl estradiol.
Day 200
Number of Participants Reporting Treatment-Emergent Adverse Events
Day 175
Assessment of mental health as determined by Columbia Suicide Severity Rating Scale (C-SSRS)
Assessment of mental health as determined by Patient Health Questionnaire-9P (HQ 9)
Change in Body Weight
Number of Participants with Clinical Laboratory Abnormalities

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Cohort 1
1
Period 2: Cyclosporine + PF-07081532
1
INDV-2000 BID + Midazolam

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Cohort 1: PF-07081532
1 of 2
Cohort 2: Semaglutide
1 of 2

Experimental Treatment

32 Total Participants · 2 Treatment Groups

Primary Treatment: Cohort 1: PF-07081532 · No Placebo Group · Phase 1

Cohort 1: PF-07081532
Drug
Experimental Group · 1 Intervention: PF-07081532 · Intervention Types: Drug
Cohort 2: Semaglutide
Drug
Experimental Group · 1 Intervention: Semaglutide · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-07081532
2022
Completed Phase 1
~150
Semaglutide
2019
Completed Phase 4
~5530

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: , 0.75, 2, 4, 8, 12, 24, 48, 72, 96, and 120 hours post dose in periods 2, 5, and 8 for cohort 1

Who is running the clinical trial?

PfizerLead Sponsor
4,396 Previous Clinical Trials
25,775,000 Total Patients Enrolled
39 Trials studying Obesity
116,867 Patients Enrolled for Obesity
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,340 Previous Clinical Trials
23,427,603 Total Patients Enrolled
28 Trials studying Obesity
120,069 Patients Enrolled for Obesity

Eligibility Criteria

Age 18+ · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a body mass index (BMI) between 30.0 and 45.4.

Who else is applying?

What state do they live in?
California100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

Is this research still recruiting test subjects?

"As advertised on clinicaltrials.gov, this research project is not presently accepting participants. Originally posted January 19th 2023 and last updated a few days later, the study has yet to resume its recruitment efforts. Though inactive at present, there are 923 other trials that are actively seeking patients for their studies." - Anonymous Online Contributor

Unverified Answer

To what degree are patients exposed to risk when taking Cohort 1: PF-07081532?

"Cohort 1: PF-07081532 has limited data gathered from Phase 1, so the safety score was evaluated as a 1 by the Power team." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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