A Study to Evaluate the Effect of the Experimental GLP-1 Drug PF-07081532 on Blood Levels of Common Birth Control Pills, and Drugs Omeprazole and Midazolam, and Effect of GLP-1 Drug Semaglutide on Midazolam Blood Levels in Healthy Adults With Weight in the Obesity Range

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Obesity

Treatments: Drug: Semaglutide; Drug: PF-07081532

Study type: Interventional

Funder types: Industry

Identifiers

NCT05671653

C3991040

NCT05671653 (Registry Identifier)

Details and patient eligibility

About

Two different groups of healthy volunteers will be chronically treated with GLP-1 drugs PF-07081532 or alternatively Semaglutide. The effect of these GLP-1 drugs on a single dose of the common sedative medication midazolam blood levels will be measured. The effect of chronic PF-07081532 on single doses of the common stomach acid medication omeprazole, and common birth control medication blood levels will also be measured. The hypothesis is that chronic administration of the GLP-1 drugs will minimally affect blood levels from these common medications.

Enrollment: 32 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy (no clinically relevant abnormalities)
• BMI 30.0-45.4 inclusive

Exclusion criteria

• Current or history of significant clinical condition
• Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 or 14 days or 5 half-lives (whichever is longer)
• Pregnant
• Breast feeding

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Cohort 1: PF-07081532

Experimental group

Description:

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:

Drug: PF-07081532

Cohort 2: Semaglutide

Experimental group

Description:

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

Treatment:

Drug: Semaglutide