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

What Was Tested

In this phase 1 trial, researchers set out to test Semaglutide.

Two different groups of healthy volunteers will be chronically treated with GLP-1 drugs PF-07081532 or alternatively Semaglutide.

It had two arms (groups): Cohort 1: PF-07081532 (experimental) and Cohort 2: Semaglutide (experimental).

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.

The registry classes the interventions as drug.

Who Took Part

The registry lists 32 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy (no clinically relevant abnormalities). BMI 30.0-45.4 inclusive.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: use of prescription or nonprescription drugs and dietary and herbal supplements within 7 or 14 days or 5 half-lives (whichever is longer); breast feeding.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

The Semaglutide group and the comparison group ran side by side rather than switching.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-01-19 with completion listed for 2023-11-03.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Cohort 1: Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Midazolam in Periods 1, 4 and 7. Cohort 1: Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Omeprazole in Periods 1, 4 and 7. Cohort 1: AUClast of Levonorgestrel (LE) in Periods 2, 5,and 8.

It also tracked 43 secondary outcomes, for example Cohort 1: Number of Participants With All-Causality and Treatment-Related TEAEs, Cohort 1: Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality), Cohort 1: Percentage of Change From Baseline in Body Weight by Period 9 Day 1, Cohort 1: Patient Health Quessionare-9 (PHQ-9) Total Scores, Cohort 1: AUCinf of Midazolam in Period 9 and Cohort 1: Maximum Observed Concentration (Cmax) of Midazolam in Period 1, 4, 7.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Semaglutide in 32 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, all human trials.