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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Placebo
Drug: PF-07081532

Study type

Interventional

Funder types

Industry

Identifiers

NCT05158244
C3991003

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

34 participants in 2 patient groups, including a placebo group

PF-07081532
Experimental group
Description:
multiple dosing, once-daily for 42 days
Treatment:
Drug: PF-07081532
Placebo
Placebo Comparator group
Description:
multiple dosing, once-daily for 42 days
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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