Phase 2
Completed N=151
A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY
Source: ClinicalTrials.gov NCT04617275 ↗Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity — 5; 4; 10; 9 Participants
Summary
This study will assess tolerability, safety, and pharmacodynamics (PD) of twice daily (BID) administration of PF- 06882961 in adult participants with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin and in non-diabetic adults with obesity
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity |
5; 4; 10; 9; 8; 10 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) |
12; 16; 17; 20; 17; 14 | — |
| SECONDARY Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization Criteria |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9) |
15; 6; 16; 20; 20; 20 | — |
| SECONDARY Change From Baseline (CFB) in Fasting Plasma Glucose at Week 2 |
-5.63; -3.32; -23.04; -36.48; -39.29; -25.15 | 0.5863 |
| SECONDARY CFB in Fasting Plasma Glucose at Week 4 |
-13.12; -16.45; -32.77; -45.92; -48.97; -41.60 | 0.3804 |
| SECONDARY CFB in Fasting Plasma Glucose at Week 6 |
-3.75; -29.33; -36.70; -43.82; -49.22; -37.38 | 0.0250 sig |
| SECONDARY CFB in Fasting Plasma Glucose at Week 8 |
-5.90; -33.69; -31.57; -52.84; -39.69; -48.02 | 0.0127 sig |
| SECONDARY CFB in Fasting Plasma Glucose at Week 10 |
-23.39; -36.24; -38.21; -57.36; -22.08; -37.81 | 0.1678 |
| SECONDARY CFB in Fasting Plasma Glucose at Week 12 |
-13.09; -41.74; -40.41; -53.94; -23.34; -37.48 | 0.0236 sig |
| SECONDARY CFB in Glycolated Hemoglobin A1c (HbA1c) at Week 2 |
-0.03; -0.12; -0.29; -0.37; -0.35; -0.20 | 0.2485 |
| SECONDARY CFB in Glycolated HbA1c at Week 4 |
-0.22; -0.33; -0.59; -0.81; -0.75; -0.58 | 0.2740 |
| SECONDARY CFB in Glycolated HbA1c at Week 6 |
-0.26; -0.49; -0.92; -1.11; -0.97; -0.93 | 0.1587 |
| SECONDARY CFB in Glycolated HbA1c at Week 8 |
-0.27; -0.71; -1.14; -1.38; -1.20; -1.18 | 0.0472 sig |
| SECONDARY CFB in Glycolated HbA1c at Week 10 |
-0.32; -1.00; -1.26; -1.48; -1.22; -1.36 | 0.0116 sig |
| SECONDARY CFB in Glycolated HbA1c at Week 12 |
-0.32; -1.07; -1.32; -1.56; -1.04; -1.57 | 0.0132 sig |
| SECONDARY CFB in Body Weight at Week 2 (Participants With T2DM) |
-0.14; -0.40; -0.22; -0.46; -0.63; -0.21 | 0.2843 |
| SECONDARY CFB in Body Weight at Week 4 (Participants With T2DM) |
-0.46; -1.23; -0.34; -1.58; -1.47; -0.41 | 0.1491 |
| SECONDARY CFB in Body Weight at Week 6 (Participants With T2DM) |
-0.38; -1.86; -0.65; -2.74; -2.23; -1.16 | 0.0395 sig |
| SECONDARY CFB in Body Weight at Week 8 (Participants With T2DM) |
-0.36; -2.52; -1.08; -3.82; -2.41; -3.32 | 0.0112 sig |
| SECONDARY CFB in Body Weight at Week 10 (Participants With T2DM) |
-0.67; -3.14; -1.71; -4.95; -3.35; -4.38 | 0.0111 sig |
| SECONDARY CFB in Body Weight at Week 12 (Participants With T2DM) |
-0.42; -3.64; -1.93; -5.38; -2.93; -5.37 | 0.0047 sig |
| SECONDARY CFB in Body Weight at Week 2 (Non-diabetic Participants With Obesity) |
0.23; -0.73 | 0.0836 |
| SECONDARY CFB in Body Weight at Week 4 (Non-diabetic Participants With Obesity) |
0.09; -1.50 | 0.0386 sig |
| SECONDARY CFB in Body Weight at Week 6 (Non-diabetic Participants With Obesity) |
-0.10; -1.59 | 0.1566 |
| SECONDARY CFB in Body Weight at Week 8 (Non-diabetic Participants With Obesity) |
0.26; -2.36 | 0.0916 |
| SECONDARY CFB in Body Weight at Week 10 (Non-diabetic Participants With Obesity) |
-0.40; -3.47 | 0.0590 |
| SECONDARY CFB in Body Weight at Week 12 (Non-diabetic Participants With Obesity) |
-0.11; -3.85 | 0.0826 |
Eligibility Criteria
Inclusion Criteria
- Male or female participants between the ages of 18 and 75 years, inclusive, at Visit 1 (screening).
Exclusion Criteria
- Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes.
- History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II IV heart failure, or transient ischemic attack within 6 months of screening (Visit 1).
- Participants with a known medical history of active liver disease (other than non alcoholic hepatic steatosis), including chronic active hepatitis B or C, or primary biliary cirrhosis.
- History of major depressive disorder or history of other severe psychiatric disorders (eg, schizophrenia or bipolar disorder) within the last 2 years.
- Any lifetime history of a suicide attempt.
Data sourced from ClinicalTrials.gov (NCT04617275). 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.