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A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE EFFECT OF TWO STEADY-STATE DOSE LEVELS OF PF-07081532 ON THE PHARMACOKINETICS OF SINGLE-DOSE MIDAZOLAM, OMEPRAZOLE AND AN ORAL CONTRACEPTIVE, AND THE EFFECT OF STEADY-STATE SEMAGLUTIDE ON THE PHARMACOKINETICS OF SINGLE-DOSE MIDAZOLAM, IN OBESE ADULT FEMALE PARTICIPANTS

Trial Profile

A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE EFFECT OF TWO STEADY-STATE DOSE LEVELS OF PF-07081532 ON THE PHARMACOKINETICS OF SINGLE-DOSE MIDAZOLAM, OMEPRAZOLE AND AN ORAL CONTRACEPTIVE, AND THE EFFECT OF STEADY-STATE SEMAGLUTIDE ON THE PHARMACOKINETICS OF SINGLE-DOSE MIDAZOLAM, IN OBESE ADULT FEMALE PARTICIPANTS

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 18 Dec 2024

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At a glance

  • Drugs Lotiglipron (Primary) ; Semaglutide (Primary) ; Ethinylestradiol; Levonorgestrel; Midazolam; Omeprazole
  • Indications Obesity
  • Focus Pharmacokinetics
  • Sponsors Pfizer

Most Recent Events

  • 19 Dec 2023 Status changed from completed to discontinued based on based on pharmacokinetic datafrom Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.
  • 08 Nov 2023 Status changed from discontinued to completed.
  • 26 Jun 2023 According to a Pfizer media release, based on pharmacokinetic data from NCT05671653, NCT05788328 and laboratory measurements of elevated transaminases in NCT05579977, the company has decided to terminate the clinical development of lotiglipron.

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