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GLP-1 Agonist

Cohort 2: Semaglutide 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
BMI 30.0-45.4 inclusive
BMI 30.0-45.4 inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up , 0.75, 2, 4, 8, 12, 24, 48, 72, 96, and 120 hours post dose in periods 2, 5, and 8 for cohort 1
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your body mass index (BMI) falls between 30 and 45.4.
Select...
Your body mass index (BMI) falls between 30.0 and 45.4.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~, 0.75, 2, 4, 8, 12, 24, 48, 72, 96, and 120 hours post dose in periods 2, 5, and 8 for cohort 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and , 0.75, 2, 4, 8, 12, 24, 48, 72, 96, and 120 hours post dose in periods 2, 5, and 8 for cohort 1 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 Extrapolated to Infinite Time (AUCinf) for levonorgestrel and ethinyl estradiol.
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 levonorgestrel and ethinyl estradiol.
+1 more
Secondary outcome measures
Apparent Oral Clearance (CL/F) for levonorgestrel and ethinyl estradiol
Apparent Oral Clearance (CL/F) for midazolam and omeprazole.
Apparent Oral Clearance (CL/F) for midazolam.
+24 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: SemaglutideExperimental Treatment1 Intervention
Cohort 2 is an open label, 4-period, fixed-sequence design to evaluate the effect of steady state semaglutide on the SD PK of midazolam in obese adult female participants with a BMI ≥30 kg/m2
Group II: Cohort 1: PF-07081532Experimental Treatment1 Intervention
Cohort 1 is an open-label, 9 period, fixed-sequence design to evaluate the effect of 2 steady state dose levels of PF-07081532 on the SD pharmacokinetics of midazolam and omeprazole, administered simultaneously, and an OC (LE/EE) in otherwise healthy obese adult female participants with a BMI ≥30 kg/m2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-07081532
2022
Completed Phase 1
~170
Semaglutide
2019
Completed Phase 4
~5160

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,556 Previous Clinical Trials
10,907,650 Total Patients Enrolled
40 Trials studying Obesity
116,930 Patients Enrolled for Obesity
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,467 Previous Clinical Trials
8,089,087 Total Patients Enrolled
29 Trials studying Obesity
120,194 Patients Enrolled for Obesity

Media Library

PF-07081532 (GLP-1 Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05671653 — Phase 1
Obesity Research Study Groups: Cohort 2: Semaglutide, Cohort 1: PF-07081532
Obesity Clinical Trial 2023: PF-07081532 Highlights & Side Effects. Trial Name: NCT05671653 — Phase 1
PF-07081532 (GLP-1 Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05671653 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
California
What portion of applicants met pre-screening criteria?
Met criteria
~15 spots leftby Mar 2025