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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05158244
• Other study ID #: C3991003
• Status: Completed
• Phase: Phase 1
• Start date: December 22, 2021
• Est. completion date: June 14, 2022

Study information

• Verified date: June 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 14, 2022
• Est. primary completion date: June 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• PF-07081532
Study Drug, once daily for 42 days
• Placebo
Placebo, once daily for 42 days

Locations

Country	Name	City	State
United States	Qps-Mra, Llc	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-emergent treatment-related adverse events		Baseline to minimum 28 days after last administration of investigational product
Primary	Number of participants with clinically significant, abnormal safety laboratory tests		Baseline to 7-14 days after last administration of investigational product
Primary	Number of participants with clinically significant, abnormal vital sign parameters		Baseline to 7-14 days after last administration of investigational product
Primary	Number of participants with clinically significant, abnormal 12-lead ECG parameters		Baseline to 7-14 days after last administration of investigational product
Secondary	Area under the curve from 0 to 24 hours post-dose (AUC24) of PF-07081532 plasma concentration		Day 1
Secondary	Area under the curve from 0 to 24 hours post-dose (AUC24) of PF-07081532 plasma concentration		Day 42
Secondary	Maximum Observed Plasma Concentration (Cmax) of PF-07081532		Day 1
Secondary	Maximum Observed Plasma Concentration (Cmax) of PF-07081532		Day 42
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07081532		Day 1
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07081532		Day 42
Secondary	Plasma Decay Half-Life (t1/2) of PF-07081532		Day 42

External Links

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