Phase 1
Completed N=66
Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT04305587 ↗Enrolled (actual)
66
Serious AEs
1.5%
Results posted
Feb 2024
Primary outcomePrimary: Number of Participants With Treatment Emergent Treatment-Related Adverse Events — 5; 2; 6; 6 Participants
Summary
This is a randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open, dose-escalating study of PF-07081532 in patients with Type 2 diabetes on metformin (Parts A and C). The study may also enroll non-diabetic participants with obesity (Part B). Study participants will receive an investigational product or placebo every day for up to 28 days (Part A) or up to 42 days (Part B, optional; Part C, optional).
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of PF-07081532 in participants with inadequately controlled T2DM on metformin and optionally in non-diabetic obese participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Treatment-Related Adverse Events |
5; 2; 6; 6; 8; 2 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities |
2; 0; 3; 2; 1; 1 | — |
| PRIMARY Number of Participants With Vital Signs Abnormalities |
0; 1; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Abnormal Electrocardiogram (ECG) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Area Under the Curve From Time 0 to 24 Hours (AUC24) Post Dose for PF-07081532 |
15530; 14430; 17220; 15100; 14340; 14560 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for PF-07081532 |
1599; 1518; 1699; 1548; 1531; 1587 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-07081532 |
1.00; 1.00; 2.00; 1.00; 1.50; 1.00 | — |
| SECONDARY Time Measured for the Plasma Concentration to Decrease by One-Half (t1/2) for PF-07081532 |
26.50; 26.36; 23.68; 24.50; 20.70; 23.07 | — |
| SECONDARY Cumulative Amount of Drug Recovered Unchanged in Urine Over 24 Hours (Ae24) for PF-07081532 |
0.1940; 0.1054 | — |
| SECONDARY Percentage of Ae24 (Ae24%) for PF-07081532 |
0.1620; 0.05848 | — |
| SECONDARY Renal Clearance (CLr) for PF-07081532 |
0.0002690; 0.0001935 | — |
Eligibility Criteria
Key Inclusion Criteria for participants enrolling with T2DM:
- Type 2 Diabetes treated with a stable dose of metformin at least 500 mg per day for at least 2 months prior to screening visit and use of no other medications for glycemic control.
- HbA1c value between 7.0% and 10.5%, inclusive.
Key Exclusion Criterion for participants enrolling with T2DM:
-Type 1 Diabetes or secondary forms of diabetes.
Key Inclusion Criterion for participants enrolling with obesity:
-Obese (as indicated by screening BMI) non-diabetic adults.
Key Exclusion Criterion for participants enrolling with obesity:
--Type 1 or Type 2 Diabetes or secondary forms of diabetes.
Data sourced from ClinicalTrials.gov (NCT04305587). 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. Informational only — not medical advice.