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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT05158244
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
5.7
Actual Duration (Months)
5.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Dec 22, 2021
Actual Primary Completion Date :
Jun 14, 2022
Actual Study Completion Date :
Jun 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: PF-07081532

multiple dosing, once-daily for 42 days

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

multiple dosing, once-daily for 42 days

Drug: Placebo
Placebo, once daily for 42 days

Outcome Measures

Primary Outcome Measures

  1. Number of participants with treatment-emergent treatment-related adverse events [Baseline to minimum 28 days after last administration of investigational product]

  2. Number of participants with clinically significant, abnormal safety laboratory tests [Baseline to 7-14 days after last administration of investigational product]

  3. Number of participants with clinically significant, abnormal vital sign parameters [Baseline to 7-14 days after last administration of investigational product]

  4. Number of participants with clinically significant, abnormal 12-lead ECG parameters [Baseline to 7-14 days after last administration of investigational product]

Secondary Outcome Measures

  1. Area under the curve from 0 to 24 hours post-dose (AUC24) of PF-07081532 plasma concentration [Day 1]

  2. Area under the curve from 0 to 24 hours post-dose (AUC24) of PF-07081532 plasma concentration [Day 42]

  3. Maximum Observed Plasma Concentration (Cmax) of PF-07081532 [Day 1]

  4. Maximum Observed Plasma Concentration (Cmax) of PF-07081532 [Day 42]

  5. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07081532 [Day 1]

  6. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07081532 [Day 42]

  7. Plasma Decay Half-Life (t1/2) of PF-07081532 [Day 42]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qps-Mra, Llc South Miami Florida United States 33143

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT05158244
Other Study ID Numbers:
  • C3991003
First Posted:
Dec 15, 2021
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pfizer
Type 2 Diabetes Mellitus
Obesity
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jun 30, 2022