Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03985293 | A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 412 | — | — | Oct 15, 2019 | Jul 7, 2021 | Jun 30, 2022 | 83 | United States, Bulgaria +6 |
| NCT04889157 | A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus | PHASE1 | COMPLETED | 20 | — | — | Jul 7, 2021 | Feb 17, 2022 | Oct 1, 2024 | 1 | China |
| NCT04616027 | STUDY OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT AND PARTICIPANTS WITHOUT RENAL IMPAIRMENT | PHASE1 | COMPLETED | 42 | — | — | Jan 13, 2021 | Feb 18, 2022 | May 10, 2024 | 3 | United States |
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
AUC24 is the area under the plasma concentration-time profile from time zero to the time 24 hours. The planned analysis was not considered reliable by the sponsor.
Cmax is the maximum observed plasma concentration over 24 hours. The planned analysis was not considered reliable by the sponsor.
AUC24 was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.
Cmax,ss was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.
Cmax was the maximum observed plasma concentration and was directly observed from data.
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity.
AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.
Fu was defined as fraction of unbound drug in plasma.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| PF-06882961 2.5 milligrams (mg) | EXPERIMENTAL | - |
| PF-06882961 10 mg | EXPERIMENTAL | - |
| PF-06882961 40 mg | EXPERIMENTAL | Participants will be titrated up to 2 weeks to reach desired dose level |
| PF-06882961 80 mg | EXPERIMENTAL | Participants will be titrated up to 4 weeks to reach desired dose level |
| PF-06882961 120 mg | EXPERIMENTAL | Participants will be titrated up to 6 weeks to reach desired dose level |
| PF-06882961 | EXPERIMENTAL | Participants will be titrated up to 6 weeks of the 8-week dosing duration to reach desired dose level 120 mg |
| Healthy participants with normal renal function | EXPERIMENTAL | This arm includes participants with normal renal function who will receive an oral dose of PF-06882961 20 milligrams (mg) on Day 1 |
| Participants with T2DM with normal renal function | EXPERIMENTAL | This arm includes participants with Type 2 Diabetes Mellitus (T2DM) with normal renal function who will receive an oral dose of PF-06882961 20 mg on Day 1 |
| Participants with T2DM with mild renal impairment | EXPERIMENTAL | This arm includes participants with Type 2 Diabetes Mellitus (T2DM) with mild renal impairment who will receive an oral dose of PF-06882961 20 mg on Day 1 |
| Participants with T2DM with moderate renal impairment | EXPERIMENTAL | This arm includes participants with Type 2 Diabetes Mellitus (T2DM) with moderate renal impairment who will receive an oral dose of PF-06882961 20 mg on Day 1 |
| Participants with T2DM with severe renal impairment | EXPERIMENTAL | This arm includes participants with Type 2 Diabetes Mellitus (T2DM) with severe renal impairment who will receive an oral dose of PF-06882961 20 mg on Day 1 |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | 4 matching placebo tablets taken twice a day (BID) |
| PF-06882961 | DRUG | Participants will be randomized to one of 5 active doses (2.5, 10, 40, 80, or 120 mg), taking 4 tablets twice daily for 16 weeks. |
| PF-06882961 20 mg | DRUG | PF-06882961 20 mg single oral dose provided in tablet form administered in a fed state on Day 1 |
Inclusion Criteria: * Patients with T2DM who are treated with metformin and/or diet and exercise * HbA1c greater than or equal to 7% and less than or equal to 10.5% * Total body weight \>50 kg (110 lb) with BMI 24.5 to 45.4 kg/m\^2 Exclusion Criteria: * Any condition possibly affecting drug absor...