A Clinical Trial of the Study Medicine (PF-07081532) in People With Diabetes and Kidney Dysfunction

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Renal Impairment; Type 2 Diabetes

Treatments: Drug: PF-07081532

Study type: Interventional

Funder types: Industry

Identifiers

NCT05510245

C3991007

Details and patient eligibility

About

The purpose of this study is to understand the effects of kidney functional impairment may have on the study medicine (PF-07081532). People with certain level of kidney functional impairment may process PF-07081532 differently from healthy people. PF-07081532 is developed as a potential treatment for type II diabetes.

Participants will take the study medicine as a tablet by mouth once at the study clinic and then will stay at the study clinic for about 7 days. During that time, the study team will monitor their treatment experience and take some blood samples to test the level of PF-07081532. This will help us understand if certain degree of kidney functional impairment will have an effect on the study medicine PF-07081532.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Stable renal function (for participants not on dialysis) defined as ≤25% difference between 2 measurements of BSA-unnormalized eGFR

2. A prior diagnosis of T2DM with an HbA1c ≥6% and ≤10.5%

3. Women may be of child-bearing potential

4. BMI of 17.5 to 45.4 kg/m2

5. NORMAL FUNCTION (GROUP 1): Normal renal function (mean eGFR ≥90 mL/min) based on an average of measures from Screening visits S1 and S2 (eGFR should be calculated using the 2021 CKD EPI Scr-Scys combined equation:

   • Demographically comparable to participants with impaired renal function at Screening
   • A body weight within ±15 kg of the mean body weight of the pooled renal impairment groups (Groups 2, 3 and 4)
   • An age within ±10 years of the mean age of the pooled renal impairment groups (Groups 2, 3 and 4)
   • 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 (Groups 2, 3 and 4).

Exclusion criteria

1. Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes, or history of diabetic ketoacidosis.
2. 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
3. Personal or family history of MTC or MEN2, or participants with suspected MTC per the investigator's judgement.
4. History of acute pancreatitis within 6 months before Screening or any history of chronic pancreatitis.
5. Urinary incontinence.
6. Participants with acute renal disease.
7. Renal allograft recipients.
8. Participants who have previously received a kidney, liver, or heart transplant.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

18 participants in 4 patient groups

Group 1

Experimental group

Description:

Participants without renal impairment will receive a single 20 mg dose of PF 07081532, administered orally

Treatment:

Drug: PF-07081532

Group 2

Experimental group

Description:

Participants with mild renal impairment will receive a single 20 mg dose of PF 07081532, administered orally

Treatment:

Drug: PF-07081532

Group 3

Experimental group

Description:

Participants with moderate renal impairment will receive a single 20 mg dose of PF 07081532, administered orally

Treatment:

Drug: PF-07081532

Group 4

Experimental group

Description:

Participants with severe renal impairment will receive a single 20 mg dose of PF 07081532, administered orally

Treatment:

Drug: PF-07081532