TerminatedPhase 1Results posted

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

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE PHARMACOKINETICS OF PF-07081532 IN ADULT PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT RENAL IMPAIRMENT

Lead sponsor

Pfizer

Asset

Lotiglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Renal impairment, Type 2 diabetes

Eligibility highlights

•BMI 17.5-45.4•HbA1c 6-10.5%

Primary endpoints

•Cmax for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg•Unbound Cmax for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg•AUC From Time 0 to Infinity (AUCinf) for PF-07081532 Following a Single Oral

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05510245

Org study IDC3991007

Timeline

Milestones

Study first posted2022-08-22actual

Study start2022-08-29actual

Primary completion2023-07-20actual

Study completion2023-07-20actual

Last update posted2024-11-05actual

Results first posted2024-11-05actual

Assets

Investigational agents

Lotiglipron

Who this study enrolls

Renal impairmentType 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Renal / kidney

5 endpoints

Primary/registry result

Maximum Observed Concentration (Cmax) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment

Time frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1

concentration, descriptive

Posted result

Group	Geometric mean · Nanograms per milliliter (ng/mL)	95% CI
Mild Renal Impairment	2084	-
Moderate Renal Impairment	1823	-
Severe Renal Impairment	1978	-

Primary/registry result

Unbound Cmax (Cmax,u) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment

Time frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1

concentration, descriptive

Posted result

Group	Geometric mean · ng/mL	95% CI
Mild Renal Impairment	0.6178	-
Moderate Renal Impairment	0.5895	-
Severe Renal Impairment	0.8239	-

Primary/registry result

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment

Time frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1

concentration, descriptive

Posted result

Group	Geometric mean · Nanogramshours/milliliter (ngh/mL)	95% CI
Mild Renal Impairment	59820	-
Moderate Renal Impairment	45600	-
Severe Renal Impairment	43870	-

Primary/registry result

Unbound AUCinf (AUCinf,u) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment

Time frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1

descriptive

Posted result

Group	Geometric mean · ng*h/mL	95% CI
Mild Renal Impairment	17.51	-
Moderate Renal Impairment	14.75	-
Severe Renal Impairment	18.44	-

Primary/registry result

Unbound Fraction (fu) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment

Time frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1

descriptive

Posted result

Group	Geometric mean · Ratio	95% CI
Mild Renal Impairment	0.0002964	-
Moderate Renal Impairment	0.0003234	-
Severe Renal Impairment	0.0004163	-

Safety / tolerability / PK

13 endpoints

Primary/protocol endpoint

Maximum Observed Concentration (Cmax) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment

Time frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1

Cmax

concentration, descriptive

Primary/protocol endpoint

Unbound Cmax (Cmax,u) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment

Time frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1

Cmax

concentration, descriptive

Primary/protocol endpoint

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment

Time frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Unbound AUCinf (AUCinf,u) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment

Time frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Unbound Fraction (fu) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment

Time frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1

ratio, descriptive

Secondary/registry result

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame:From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose)

event count, event

Posted result

Group	Participants	95% CI
Mild Renal ImpairmentParticipants With All-Causality TEAEs	1	-
Participants With All-Causality SAEs	0	-
Participants With All-Causality Severe TEAEs	0	-
Participants With Treatment-Related TEAEs	0	-
Participants With Treatment-Related SAEs	0	-
Participants With Treatment-Related Severe TEAEs	0	-
Moderate Renal ImpairmentParticipants With All-Causality TEAEs	2	-
Participants With All-Causality SAEs	0	-
Participants With All-Causality Severe TEAEs	0	-
Participants With Treatment-Related TEAEs	2	-
Participants With Treatment-Related SAEs	0	-
Participants With Treatment-Related Severe TEAEs	0	-
Severe Renal ImpairmentParticipants With All-Causality TEAEs	1	-
Participants With All-Causality SAEs	0	-
Participants With All-Causality Severe TEAEs	0	-
Participants With Treatment-Related TEAEs	0	-
Participants With Treatment-Related SAEs	0	-
Participants With Treatment-Related Severe TEAEs	0	-

Secondary/registry result

Number of Participants With Laboratory Test Abnormalities

Time frame:Pre-dose, 72 and 144 hours post dose on Day 1

event count, event

Posted result

Group	Participants	95% CI
Mild Renal ImpairmentHematology-Hemoglobin (grams per deciliter [g/dL])<0.8*lower limit of normal (LLN)	0	-
Hematology-Hematocrit (%)<0.8*LLN	0	-
Hematology-Erythrocytes (10^12/Liter [L])<0.8*LLN	0	-
Hematology-Eosinophils (10^9/L)>1.2* upper limit of normal (ULN)	0	-
Clinical Chemistry-Gamma Glutamyl Transferase (units [U]/L)>3.0*ULN	0	-
Clinical Chemistry-Urea Nitrogen (milligrams [mg] / dL)>1.3*ULN	1	-
Clinical Chemistry-Creatinine (mg/dL)>1.3*ULN	0	-
Clinical Chemistry-Urate (mg/dL)>1.2*ULN	0	-
Clinical Chemistry-Potassium (milliequivalents [mEq] / L)>1.1*ULN	0	-
Clinical Chemistry-Magnesium (mg/dL)<0.9*LLN	0	-
Clinical Chemistry-Phosphate (mg/dL)<0.8*LLN	0	-
Clinical Chemistry-Phosphate (mg/dL)>1.2*ULN	0	-
Clinical Chemistry-Bicarbonate (mEq/L)<0.9*LLN	0	-
Clinical Chemistry-Fasting Glucose (mg/dL)>1.5*ULN	1	-
Urinalysis-Urine Glucose Positive	0	-
Urinalysis-Urine Protein Positive	0	-
Urinalysis-Urine Hemoglobin Positive	0	-
Urinalysis-Nitrite Positive	1	-
Urinalysis-Leukocyte Esterase Positive	1	-
Moderate Renal ImpairmentHematology-Hemoglobin (grams per deciliter [g/dL])<0.8*lower limit of normal (LLN)	1	-
Hematology-Hematocrit (%)<0.8*LLN	0	-
Hematology-Erythrocytes (10^12/Liter [L])<0.8*LLN	1	-
Hematology-Eosinophils (10^9/L)>1.2* upper limit of normal (ULN)	0	-
Clinical Chemistry-Gamma Glutamyl Transferase (units [U]/L)>3.0*ULN	0	-
Clinical Chemistry-Urea Nitrogen (milligrams [mg] / dL)>1.3*ULN	4	-
Clinical Chemistry-Creatinine (mg/dL)>1.3*ULN	3	-
Clinical Chemistry-Urate (mg/dL)>1.2*ULN	0	-
Clinical Chemistry-Potassium (milliequivalents [mEq] / L)>1.1*ULN	0	-
Clinical Chemistry-Magnesium (mg/dL)<0.9*LLN	1	-
Clinical Chemistry-Phosphate (mg/dL)<0.8*LLN	0	-
Clinical Chemistry-Phosphate (mg/dL)>1.2*ULN	1	-
Clinical Chemistry-Bicarbonate (mEq/L)<0.9*LLN	0	-
Clinical Chemistry-Fasting Glucose (mg/dL)>1.5*ULN	3	-
Urinalysis-Urine Glucose Positive	1	-
Urinalysis-Urine Protein Positive	2	-
Urinalysis-Urine Hemoglobin Positive	0	-
Urinalysis-Nitrite Positive	0	-
Urinalysis-Leukocyte Esterase Positive	1	-
Severe Renal ImpairmentHematology-Hemoglobin (grams per deciliter [g/dL])<0.8*lower limit of normal (LLN)	4	-
Hematology-Hematocrit (%)<0.8*LLN	4	-
Hematology-Erythrocytes (10^12/Liter [L])<0.8*LLN	4	-
Hematology-Eosinophils (10^9/L)>1.2* upper limit of normal (ULN)	1	-
Clinical Chemistry-Gamma Glutamyl Transferase (units [U]/L)>3.0*ULN	1	-
Clinical Chemistry-Urea Nitrogen (milligrams [mg] / dL)>1.3*ULN	7	-
Clinical Chemistry-Creatinine (mg/dL)>1.3*ULN	8	-
Clinical Chemistry-Urate (mg/dL)>1.2*ULN	1	-
Clinical Chemistry-Potassium (milliequivalents [mEq] / L)>1.1*ULN	1	-
Clinical Chemistry-Magnesium (mg/dL)<0.9*LLN	0	-
Clinical Chemistry-Phosphate (mg/dL)<0.8*LLN	1	-
Clinical Chemistry-Phosphate (mg/dL)>1.2*ULN	0	-
Clinical Chemistry-Bicarbonate (mEq/L)<0.9*LLN	1	-
Clinical Chemistry-Fasting Glucose (mg/dL)>1.5*ULN	2	-
Urinalysis-Urine Glucose Positive	1	-
Urinalysis-Urine Protein Positive	5	-
Urinalysis-Urine Hemoglobin Positive	1	-
Urinalysis-Nitrite Positive	1	-
Urinalysis-Leukocyte Esterase Positive	2	-

Secondary/registry result

Number of Participants With Vital Signs Data Meeting Pre-Defined Categorical Criteria

Time frame:At admission on Day -1, pre-dose, and 24, 72, and 144 hours post the dose on Day 1

event count, event

Posted result

Group	Participants	95% CI
Mild Renal ImpairmentSystolic BP (mm Hg) Increase >=30 mm Hg	0	-
Diastolic BP (mm Hg) Increase >=20 mm Hg	0	-
Diastolic BP (mm Hg) Decrease >=20 mm Hg	0	-
Moderate Renal ImpairmentSystolic BP (mm Hg) Increase >=30 mm Hg	1	-
Diastolic BP (mm Hg) Increase >=20 mm Hg	0	-
Diastolic BP (mm Hg) Decrease >=20 mm Hg	0	-
Severe Renal ImpairmentSystolic BP (mm Hg) Increase >=30 mm Hg	1	-
Diastolic BP (mm Hg) Increase >=20 mm Hg	1	-
Diastolic BP (mm Hg) Decrease >=20 mm Hg	1	-

Secondary/registry result

Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Defined Categorical Criteria

Time frame:Pre-dose, and 144 hours post the dose on Day 1

event count, event

Posted result

Group	Participants	95% CI
Mild Renal Impairment	1	-
Moderate Renal Impairment	1	-
Severe Renal Impairment	2	-

Secondary/protocol endpoint

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame:From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Laboratory Test Abnormalities

Time frame:Pre-dose, 72 and 144 hours post dose on Day 1

descriptive

Secondary/protocol endpoint

Number of Participants With Vital Signs Data Meeting Pre-Defined Categorical Criteria

Time frame:At admission on Day -1, pre-dose, and 24, 72, and 144 hours post the dose on Day 1

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Defined Categorical Criteria

Time frame:Pre-dose, and 144 hours post the dose on Day 1

threshold achievement, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.