STUDY OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT AND PARTICIPANTS WITHOUT RENAL IMPAIRMENT

Completed · Phase 1

Conditions studied: Diabetes Mellitus, Type 2, Renal Impairment, Healthy

In brief

This study will characterize the effect of varying degrees of renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of PF- 06882961 compared with participants with normal renal function.

Key facts

Study ID

NCT04616027

Run by

Pfizer

People needed

42

Starts

2021-01-13

Expected to finish

2022-02-18

Last updated by the study team

2024-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Stable renal function (for participants not on dialysis) defined as ≤25% difference between 2 measurements of eGFR (as calculated by the sponsor-identified central laboratory using the CKD-EPI equation)1 obtained at Screening visits S1 and S2. The average of the 2 eGFR values obtained from S1 and S2 will be used for study enrollment and assignment to appropriate renal function group. Note: participants on dialysis will be placed in Group 5 regardless of eGFR from S1 and S2 (S2 is optional for dialysis participants only).
• Male and female participants must be ≥18 years of age, inclusive, at the time of signing the informed consent document (ICD).
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures, including the ability to perform self-monitoring blood glucose at a frequency deemed appropriate by the investigator.
• Body mass index (BMI) of ≥18.0 kg/m2 and <45.4 kg/m2; and a total body weight >50 kg (110 lb).
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
• Additional Inclusion Criteria for Healthy Participants with Normal Renal
• Function (Group 1):
• No clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate measurement, standard 12-lead ECG and clinical laboratory tests.
• Normal renal function (mean eGFR ≥90 mL/min) based on an average of measures from Screening visits S1 and S2.
• Demographically comparable to participants with impaired renal function:
• A body weight within ±15 kg of the mean body weight of the pooled renal impairment groups (Groups 3, 4, and 5), as provided by sponsor;
• An age within ±10 years of the mean age of the pooled renal impairment groups (Groups 3, 4 and 5), as provided by sponsor;
• Attempts will be made to ensure that the male to female distribution in Group 1 is comparable to that in the pooled renal impairment groups (Cohorts 3, 4, and 5).
• Additional Inclusion Criteria for T2DM Participants with Normal Renal
• Function (Group 2):
• A prior diagnosis of T2DM with an HbA1c ≥6% and ≤10.5%, at Screening visit S1, confirmed by a single repeat, if deemed necessary.
• Normal renal function (mean eGFR ≥90 mL/min) based on an average of measures from Screening visits S1 and S2.
• Prohibited prior/concomitant medications.
• Demographically comparable to participants with impaired renal function:
• A body weight within ±15 kg of the mean body weight of the pooled renal impairment groups (Groups 3, 4, and 5), as provided by sponsor;
• An age within ±10 years of the mean age of the pooled renal impairment groups (Groups 3, 4, and 5), as provided by sponsor;
• Attempts will be made to ensure that the male to female distribution in Group 2 is comparable to that in the pooled renal impairment groups (Cohorts 3, 4, and 5).
• Additional Inclusion Criteria for T2DM Participants with Impaired Renal Function (Groups 3-5):
• A prior diagnosis of T2DM with an HbA1c ≥6% and ≤10.5%, at Screening visit S1, confirmed by a single repeat, if deemed necessary.
• Meet the eGFR criteria listed for Groups 3, 4, or 5 (for participants not on dialysis) in Table 1 based on an average of measures from Screening visits S1 and S2.

You may not qualify if…

• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, or any area of intestinal resection, active inflammatory bowel disease or pancreatic insufficiency). NOTE: subjects who have undergone cholecystectomy and/or appendectomy are eligible for this study so long as the surgery occurred more than 6 months prior to Screening;
• Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin); a participant is considered cured if there has been no evidence of cancer recurrence in the previous 5 years.
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the investigator's judgement.
• History of chronic or acute pancreatitis within 5 years.
• Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes.
• History of diabetic ketoacidosis.
• History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II-IV heart failure, or transient ischemic attack within 3 months of Screening visit S1.
• Urinary incontinence.
• Participants with acute renal disease.
• Renal allograft recipients.
• Participants with other clinically significant disease, in the judgment of the investigator that may affect the safety of the participant or that may affect the PK of PF 06882961.
• Prohibited prior/concomitant medications.
• Compliance with details regarding prohibited prior/concomitant medications.
• Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of IP used in this study (whichever is longer).
• Known prior participation in a trial involving PF 06882961 or known hypersensitivity or intolerance to a GLP-1R agonist.
• Screening standard 12-lead ECG that demonstrates a clinically relevant abnormality that requires further diagnostic evaluation or intervention (eg, new, clinically relevant arrhythmia, conduction disturbance, findings suggestive of ischemia). A potential participant whose pre-dose ECG (on Day 1, 0 hour) demonstrates a clinically relevant abnormality that requires further diagnostic evaluation or intervention will be considered a screen failure.
• A positive COVID-19 test in the screening period.
• A positive urine drug test (or other type of drug test in anuric participants on dialysis only).
• Participants with ANY of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study specific central laboratory and confirmed by a single repeat test, if deemed necessary:
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥2 × upper limit of normal (ULN);
• Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
• Fasting C-peptide <0.8 ng/mL.
• Fasting plasma glucose (FPG) >270 mg/dL (15 mmol/L) at screening (S1).
• History of regular alcohol consumption exceeding 7 drinks/week for female participants or 14 drinks/week for male participants (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.

Where it is running

• University of Miami Hospital — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• Prism Research LLC dba Nucleus Network — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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