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Trial · Interventional

TerminatedPhase 1Results postedRegistry data

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

NCTNCT05671653 (opens ClinicalTrials.gov in a new tab)Other idC3991040Other idNCT05671653
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 1
Enrollment
32 participants (actual)
Sponsor
Pfizer · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
19 Jan 2023
Primary completion
3 Nov 2023
Completion
3 Nov 2023
First posted
5 Jan 2023
Last update posted
14 Jan 2025
Conditions
Obesity

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20232024
  1. Ph 1

    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

    NCT05671653

    19 Jan 2023 to 3 Nov 2023

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • PF-07081532Drug
  • SemaglutideDrug

Arms2

  • Experimental

    Cohort 1: PF-07081532

    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.

  • Experimental

    Cohort 2: Semaglutide

    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

Primary outcomes5

Outcomes the sponsor listed as primary.

  1. 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

    Time frame · For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period

    Registry description

    Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.

  2. 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

    Time frame · For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period

    Registry description

    Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. AUClast calculated area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.

  3. Cohort 1: AUClast of Levonorgestrel (LE) in Periods 2, 5,and 8

    Time frame · For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period

    Registry description

    LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. AUClast calculated area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.

  4. Cohort 1: AUCinf of Ethinyl Estradiol (EE) in Periods 2, 5,and 8

    Time frame · For Cohort 1 Periods 2, 5, and 8: At 0 (prior to EE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period

    Registry description

    EE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for EE PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.

  5. Cohort 2: AUCinf of Midazolam in Period 1 and 3

    Time frame · For Cohort 2 Periods 1 and 3: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period

    Registry description

    Midazolam was given on Day 1 in Period 1 and 3 of Cohort 2 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.

Secondary outcomes(20)

  1. Cohort 1: Number of Participants With All-Causality and Treatment-Related TEAEs

    Time frame · From first dose (Day 1) to follow-up telephone contact (Days 153 to 160) in Cohort 1

    Registry description

    An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Relatedness to study treatment was assessed by the investigator. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were events between first dose of study treatment and up to approximately 35 days that were absent before treatment or that worsened relative to pretreatment state.

  2. Cohort 1: Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)

    Time frame · From first dose (Day 1) to follow-up telephone contact (Days 153 to 160) in Cohort 1

    Registry description

    Laboratory tests (including hematology, clinical chemistry, urinalysis) were reported and abnormalities were defined for laboratory values that met specific criteria.

  3. Cohort 1: Percentage of Change From Baseline in Body Weight by Period 9 Day 1

    Time frame · From baseline (last pre-dose measurement in Period 1) to Period 9 Day 1 (Day 124)

    Registry description

    Percentage of changes from Baseline in body weight of the participants were measured.

  4. Cohort 1: Number of Participants With Completed Suicide, Suicide Attempt, Preparatory Acts Towards Imminent Suicidal Behavior, Suicidal Ideation, or Self-Injurious Behavior of No Suicidal Intent As Assessed on the C-SSRS

    Time frame · Screening, Study Day -1 (D-1) (ie, Period 1 Day -1 [P1D-1]), D7 (P3D1), D21 (P3D15), D35 (P4D1), D54 (P6D14), D68 (P6D28), D82 (P6D42), D96 (P6D56), D103 (P6D63), D110 (P8D6) and at follow up visit D132-135

    Registry description

    The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS items were mapped to the following categories: completed suicide, suicide attempt, preparatory acts towards imminent suicidal behavior, suicidal ideation, and self-injurious behavior of no suicidal intent. Number of participants with completed suicide, suicide attempt, preparatory acts towards imminent suicidal behavior, suicidal ideation, or self-injurious behavior of no suicidal intent as assessed on the C-SSRS are reported below.

  5. Cohort 1: Patient Health Quessionare-9 (PHQ-9) Total Scores

    Time frame · Screening, Study Day -1 (D-1) (ie, Period 1 Day -1 [P1D-1]), D7 (P3D1), D21 (P3D15), D35 (P4D1), D54 (P6D14), D68 (P6D28), D82 (P6D42), D96 (P6D56), D103 (P6D63), D110 (P8D6) and at follow up visit D132-135

    Registry description

    The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The PHQ-9 is completed by participants and reviewed by site staff at the pre-defined time points. The total score is derived by adding the corresponding values of responses to each item. The total score ranges from 0 to 27, with the following interpretation: 1-4: Minimal depression; 5-9: Mild depression; 10-14: Moderate depression; 15-19: Moderately severe depression; 20-27: Severe depression.

  6. Cohort 1: AUCinf of Midazolam in Period 9

    Time frame · For Cohort 1 Period 9: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1

    Registry description

    Midazolam was given on Day 1 in Period 9 of Cohort 1 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.

  7. Cohort 1: Maximum Observed Concentration (Cmax) of Midazolam in Period 1, 4, 7

    Time frame · For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period

    Registry description

    Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.

  8. Cohort 1: Time for Cmax (Tmax) of Midazolam in Period 1, 4, 7

    Time frame · For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period

    Registry description

    Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. Tmax was defined as time for Cmax and was observed directly from data.

  9. Cohort 1: Apparent Clearance (CL/F) of Midazolam in Period 1, 4, 7

    Time frame · For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period

    Registry description

    Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. CL/F was defined as apparent clearance and was calculated as dose/AUCinf.

  10. Cohort 1: Apparent Volume of Distribution (Vz/F) of Midazolam in Period 1, 4, 7

    Time frame · For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period

    Registry description

    Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. Vz/F was defined as apparent volume of distribution and was calculated as dose/(AUCinf\*kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.

  11. Cohort 1: Terminal Half-Life (t1/2) of Midazolam in Period 1, 4, 7

    Time frame · For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period

    Registry description

    Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. t1/2 was defined as terminal half life and was calculated as loge(2)/kel.

  12. Cohort 1: Cmax of Omeprazole in Period 1, 4, 7

    Time frame · For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period

    Registry description

    Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.

  13. Cohort 1: Tmax of Omeprazole in Period 1, 4, 7

    Time frame · For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period

    Registry description

    Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. Tmax was defined as time for Cmax and was observed directly from data.

  14. Cohort 1: CL/F of Omeprazole in Period 1, 4, 7

    Time frame · For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period

    Registry description

    Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. CL/F was defined as apparent clearance and was calculated as dose/AUCinf.

  15. Cohort 1: Vz/F of Omeprazole in Period 1, 4, 7

    Time frame · For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period

    Registry description

    Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. Vz/F was defined as apparent volume of distribution and was calculated as dose/(AUCinf\*kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.

  16. Cohort 1: t1/2 of Omeprazole in Period 1, 4, 7

    Time frame · For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period

    Registry description

    Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. Vz/F was defined as apparent volume of distribution and was calculated as dose/(AUCinf ×kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.

  17. Cohort 1: Cmax of LE in Period 2, 5, 8

    Time frame · For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period

    Registry description

    LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.

  18. Cohort 1: Tmax of LE in Period 2, 5, 8

    Time frame · For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period

    Registry description

    LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.

  19. Cohort 1: CL/F of LE in Period 2, 5, 8

    Time frame · For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period

    Registry description

    LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.

  20. Cohort 1: Vz/F of LE in Period 2, 5, 8

    Time frame · For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period

    Registry description

    LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. Vz/F was defined as apparent volume of distribution and was calculated as dose/(AUCinf\*kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period

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

GroupValue (nanogram*hour/milliliter (ng*hr/mL))Spread
Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)39.2733
Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)33.3037
Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)28.2349
Primary outcomeGeometric mean· For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period

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

GroupValue (ng*hr/mL)Spread
Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)956.390
Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)620.5174
Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)602.8154
Primary outcomeGeometric mean· For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period

Cohort 1: AUClast of Levonorgestrel (LE) in Periods 2, 5,and 8

GroupValue (picogram*hour/milliliter (pg*hr/mL))Spread
Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)3136052
Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)4212056
Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)6002063
Primary outcomeGeometric mean· For Cohort 1 Periods 2, 5, and 8: At 0 (prior to EE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period

Cohort 1: AUCinf of Ethinyl Estradiol (EE) in Periods 2, 5,and 8

GroupValue (pg*hr/mL)Spread
Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)754.537
Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)765.526
Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)701.129
Primary outcomeGeometric mean· For Cohort 2 Periods 1 and 3: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period

Cohort 2: AUCinf of Midazolam in Period 1 and 3

GroupValue (ng*hr/mL)Spread
Cohort 2: Midazolam 2 mg (Period 1)34.4343
Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3)34.6048
Secondary and other outcome results(3)
Secondary outcomeCount of participants· From first dose (Day 1) to follow-up telephone contact (Days 153 to 160) in Cohort 1

Cohort 1: Number of Participants With All-Causality and Treatment-Related TEAEs

GroupValue (Participants)
Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)1
Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)2
Cohort 1: PF-07081532 Titration up to 80 mg QD (Period 3)14
Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)2
Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)6
Cohort 1: PF-07081532 Titration up to 260 mg QD (Period 6)15
Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)1
Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)2
Cohort 1: Midazolam 2 mg (Period 9)2
Secondary outcomeCount of participants· From first dose (Day 1) to follow-up telephone contact (Days 153 to 160) in Cohort 1

Cohort 1: Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)

GroupValue (Participants)
Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)0
Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)0
Cohort 1: PF-07081532 Titration up to 80 mg QD (Period 3)9
Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)0
Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)3
Cohort 1: PF-07081532 Titration up to 260 mg QD (Period 6)14
Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)3
Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)6
Cohort 1: Midazolam 2 mg (Period 9)7
Secondary outcomeMedian· From baseline (last pre-dose measurement in Period 1) to Period 9 Day 1 (Day 124)

Cohort 1: Percentage of Change From Baseline in Body Weight by Period 9 Day 1

GroupValue (Percentage Change)
All Participants-8.55

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1.0 / 160 / 161 / 16
Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2.0 / 160 / 162 / 16
Cohort 1: PF-07081532 Titration up to 80 mg QD (Period 3)Participants in Cohort 1 received PF-07081532 20 mg once daily (QD) on Day 1-7, 40 mg QD on Day 8-14, 60 mg QD on Day 15-21, 80 mg QD on Day 22-28 of Period 3.0 / 160 / 1614 / 16
Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4.0 / 160 / 162 / 16
Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5.0 / 160 / 166 / 16
Cohort 1: PF-07081532 Titration up to 260 mg QD (Period 6)Participants in Cohort 1 received PF-07081532 100 mg QD on Day 1-7, 120 mg QD on DAY 8-14, 140 mg QD on Day 15-21, 160 mg QD on Day 22-28, 180 mg QD on Day 29-35, 200 mg QD on Day 36-42, 220 mg QD on Day 43-49, 240 mg QD on Day 50-56, 260 mg QD on Day 57-63 of Period 6.0 / 160 / 1615 / 16
Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7.0 / 80 / 81 / 8
Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)Participants in Cohort 1 received PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8.0 / 70 / 72 / 7
Cohort 1: Midazolam 2 mg (Period 9)Participants in Cohort 1 received SD of midazolam 2 mg on Day 1 of Period 9.0 / 80 / 82 / 8
Cohort 2: Midazolam 2 mg (Period 1)Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 1.0 / 160 / 164 / 16
Cohort 2: Semaglutide Titration up to 2.4 mg QW (Period 2)Participants in Cohort 2 received semaglutide 0.25 mg once weekly (QW) on Week 1-4, 0.5 mg QW on Week 5-8, 1.0 mg QW on Week 9-12, 1.7 mg QW on Week 13-16, 2.4 mg QW on Week 17-21 of Period 2.0 / 160 / 1611 / 16
Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3)Participants in Cohort 2 received semaglutide 2.4 mg QW and SD of midazolam 2 mg on Day 1 of Period 3.0 / 110 / 1111 / 11
Cohort 2: Midazolam 2 mg (Period 4)Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 4.0 / 100 / 103 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2026

1 result

Assessment of the Drug-Drug Interaction Potential of Lotiglipron (PF-07081532) with Midazolam, Omeprazole, Dabigatran, Rosuvastatin, and the Oral Contraceptives Levonorgestrel and Ethinyl Estradiol.

Cronenberger et al. 2026Journal of clinical pharmacologycited by 1

PMID 42053447PMC13127352DOI 10.1002/jcph.70158PUB-42053447

Free to read · publisher termsCC BY-NC-ND1 result
Read at sourceSee results (1)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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