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Study of Multiple Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-07081532

Placebo

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Females of non childbearing potential;
Patients with T2DM, inadequately controlled with metformin;
HbA1c ≥7.0% to ≤10.5% (for T2DM); HbA1c <6.5% (for non-diabetic obese, if enrolled)
Total body weight >50 kg (110 lbs)
BMI ≥24.5 to ≤45.5 kg/m2 (T2DM), BMI >30.5 to ≤45.5 kg/m2 (for non-diabetic obese)

Exclusion Criteria

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, neurological, dermatological, or allergic disease;
Medical history of T2DM (for non-diabetic obese participants, if enrolled);
Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;
Evidence or history of clinically significant cardiovascular disease;
Any malignancy not considered cured;
Acute pancreatitis or history of chronic pancreatitis;
Acute gallbladder disease;
Any condition possibly affecting drug absorption;
Personal or family history of MTC or MEN2;
Medical or psychiatric condition that may increase the risk of study participation;
Any vaccination within the 1 week prior to admission to the CRU;
Previous administration with an investigational drug within 30 days or 5 half-lives preceding first dose;
Known prior participation in a trial involving PF-07081532;
A positive urine drug screen at screening or admission;
Positive testing at screening for HIV, HBsAg, HBcAb, HBsAb or HCVAb;
Positive COVID-19 test at screening or admission;
Supine BP ≥160 mm Hg (systolic) or ≥100 mm Hg (diastolic);
12-lead ECG clinically relevant abnormalities that may affect participant safety or interpretation of study results;
Participants with ANY of the following abnormalities in clinical laboratory tests: *AST or ALT level ≥1.5x ULN;
- Total bilirubin level ≥1.5x ULN;
- TSH> ULN;
- Fasting C-peptide <0.8 ng/mL;
- Serum calcitonin > ULN;
- Amylase > ULN;
- Lipase > ULN;
- eGFR <60 mL/min/1.73m2 (per MDRD equation);
- FPG >270 mg/dL
History of alcohol abuse, binge drinking and/or any illicit drug use or dependence within 6 months of Screening;
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing;
History of sensitivity to heparin or heparin induced thrombocytopenia;
Known intolerance to any GLP-1R agonist.

Sites / Locations

Qps-Mra, Llc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-07081532

Placebo

Arm Description

multiple dosing, once-daily for 42 days

Outcomes

Primary Outcome Measures

Number of participants with treatment-emergent treatment-related adverse events

Number of participants with clinically significant, abnormal safety laboratory tests

Number of participants with clinically significant, abnormal vital sign parameters

Number of participants with clinically significant, abnormal 12-lead ECG parameters

Secondary Outcome Measures

Area under the curve from 0 to 24 hours post-dose (AUC24) of PF-07081532 plasma concentration

Maximum Observed Plasma Concentration (Cmax) of PF-07081532

Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07081532

Plasma Decay Half-Life (t1/2) of PF-07081532

Full Information

NCT ID

NCT05158244

First Posted

December 2, 2021

Last Updated

June 28, 2022

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT05158244

Brief Title

Study of Multiple Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus

Official Title

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE ORAL DOSES OF PF-07081532 IN ADULT PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

December 22, 2021 (Actual)

Primary Completion Date

June 14, 2022 (Actual)

Study Completion Date

June 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a Phase 1, randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open study of PF-07081532. Study participants will receive the investigational product or placebo every day for 42 days. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of multiple oral doses of PF-07081532 in participants with inadequately controlled type 2 diabetes mellitus, on metformin and optionally in non-diabetic participants with obesity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, Obesity

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-07081532

Arm Type

Experimental

Arm Description

multiple dosing, once-daily for 42 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

multiple dosing, once-daily for 42 days

Intervention Type

Drug

Intervention Name(s)

PF-07081532

Intervention Description

Study Drug, once daily for 42 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo, once daily for 42 days

Primary Outcome Measure Information:

Title

Number of participants with treatment-emergent treatment-related adverse events

Time Frame

Baseline to minimum 28 days after last administration of investigational product

Title

Number of participants with clinically significant, abnormal safety laboratory tests

Time Frame

Baseline to 7-14 days after last administration of investigational product

Title

Number of participants with clinically significant, abnormal vital sign parameters

Time Frame

Baseline to 7-14 days after last administration of investigational product

Title

Number of participants with clinically significant, abnormal 12-lead ECG parameters

Time Frame

Baseline to 7-14 days after last administration of investigational product

Secondary Outcome Measure Information:

Title

Area under the curve from 0 to 24 hours post-dose (AUC24) of PF-07081532 plasma concentration

Time Frame

Day 1

Title

Area under the curve from 0 to 24 hours post-dose (AUC24) of PF-07081532 plasma concentration

Time Frame

Day 42

Title

Maximum Observed Plasma Concentration (Cmax) of PF-07081532

Time Frame

Day 1

Title

Maximum Observed Plasma Concentration (Cmax) of PF-07081532

Time Frame

Day 42

Title

Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07081532

Time Frame

Day 1

Title

Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07081532

Time Frame

Day 42

Title

Plasma Decay Half-Life (t1/2) of PF-07081532

Time Frame

Day 42

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Females of non childbearing potential; Patients with T2DM, inadequately controlled with metformin; HbA1c ≥7.0% to ≤10.5% (for T2DM); HbA1c <6.5% (for non-diabetic obese, if enrolled) Total body weight >50 kg (110 lbs) BMI ≥24.5 to ≤45.5 kg/m2 (T2DM), BMI >30.5 to ≤45.5 kg/m2 (for non-diabetic obese) Exclusion Criteria Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, neurological, dermatological, or allergic disease; Medical history of T2DM (for non-diabetic obese participants, if enrolled); Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes; Evidence or history of clinically significant cardiovascular disease; Any malignancy not considered cured; Acute pancreatitis or history of chronic pancreatitis; Acute gallbladder disease; Any condition possibly affecting drug absorption; Personal or family history of MTC or MEN2; Medical or psychiatric condition that may increase the risk of study participation; Any vaccination within the 1 week prior to admission to the CRU; Previous administration with an investigational drug within 30 days or 5 half-lives preceding first dose; Known prior participation in a trial involving PF-07081532; A positive urine drug screen at screening or admission; Positive testing at screening for HIV, HBsAg, HBcAb, HBsAb or HCVAb; Positive COVID-19 test at screening or admission; Supine BP ≥160 mm Hg (systolic) or ≥100 mm Hg (diastolic); 12-lead ECG clinically relevant abnormalities that may affect participant safety or interpretation of study results; Participants with ANY of the following abnormalities in clinical laboratory tests: *AST or ALT level ≥1.5x ULN; Total bilirubin level ≥1.5x ULN; TSH> ULN; Fasting C-peptide <0.8 ng/mL; Serum calcitonin > ULN; Amylase > ULN; Lipase > ULN; eGFR <60 mL/min/1.73m2 (per MDRD equation); FPG >270 mg/dL History of alcohol abuse, binge drinking and/or any illicit drug use or dependence within 6 months of Screening; Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing; History of sensitivity to heparin or heparin induced thrombocytopenia; Known intolerance to any GLP-1R agonist.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Qps-Mra, Llc

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=C3991003

Description

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Study of Multiple Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus

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