Phase 1
N=34
Study of Multiple Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT05158244 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (All Causalities) — 5; 7; 6; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-07081532 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (All Causalities) |
5; 7; 6; 0; 7; 0 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (Treatment Related) |
5; 6; 6; 0; 7; 0 | — |
| PRIMARY Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Pre-specified Categorical Post-Baseline Vital Signs Data |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Pre-specified Categorical Post-Baseline Electrocardiogram (ECG) Data |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Area Under the Concentration-Time Profile From 0 to 24 Hours (AUC24) of PF-07081532 on Day 1 and Day 42 |
27000; 60280; 27840; 141000; 198400; 146600 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of PF-07081532 on Day 1 and Day 42 |
2877; 5432; 2771; 9877; 14470; 11970 | — |
| SECONDARY Time to Reach Cmax (Tmax) of PF-07081532 on Day 1 and Day 42 |
1.00; 1.00; 2.00; 2.00; 5.00; 2.00 | — |
| SECONDARY Terminal Half-life (t1/2) of PF-07081532 on Day 42 |
25.89; 26.04; 24.37 | — |
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.
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 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 ULN;
- Amylase > ULN;
- Lipase > ULN;
- eGFR 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.
Data sourced from ClinicalTrials.gov (NCT05158244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.