Phase 1
Completed N=16
Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity
Source: ClinicalTrials.gov NCT04621227 ↗Enrolled (actual)
16
Serious AEs
0.9%
Results posted
Dec 2023
Primary outcomePrimary: Area Under the Plasma Concentration-time Profile From Time 0 to Last Quantifiable Concentration (AUClast) of Rosuvastatin in Periods 1, 4 and 7 — 35.17; 72.15; 100.90 nanogram*hour per milliliter (ng*hr/mL)
Summary
A Phase 1 Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Profile From Time 0 to Last Quantifiable Concentration (AUClast) of Rosuvastatin in Periods 1, 4 and 7 |
35.17; 72.15; 100.90 | — |
| PRIMARY AUClast of Midazolam in Periods 2, 5 and 8 |
39.24; 19.98; 20.21 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
0; 2; 13; 6; 5; 11 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality) |
0; 3; 5; 2; 3; 5 | — |
| SECONDARY Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Body Weight |
-1.5; -1.9; -3.3; -4.3; -5.2; -6.1 | — |
| SECONDARY Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria |
0; 0; 0; 1; 1; 0 | — |
| SECONDARY Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9) |
16; 0; 0; 0; 16; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Body Mass Index (BMI) ≥ 30.0 kg/m2 and not more than 45.4 kg/m2 at Screening.
- Stable body weight, defined as <5 kg change (per participant report) for 90 days before Screening
Exclusion Criteria
- Known prior participation in a trial involving PF-06882961.
- Known intolerance or hypersensitivity to GLP-1R agonists.
- Known hypersensitivity to rosuvastatin or midazolam.
- Diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at screening. Note: prior diagnoses of gestational diabetes during pregnancy only are eligible if they meet the other eligibility criteria
- Any lifetime history of a suicide attempt.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
- Participation in a formal weight reduction program (eg, Weight Watchers) within 90 days prior to Screening.
Data sourced from ClinicalTrials.gov (NCT04621227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.