A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06882961 TITRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS TREATED WITH METFORMIN AND IN NON-DIABETIC ADULTS WITH OBESITY
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 151
- 试验地点
- 37
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants between the ages of 18 and 75 years, inclusive, at Visit 1 (screening).
排除标准
- •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.
研究组 & 干预措施
Arm 1-PF-06882961 starting dose of 5 milligram (mg) BID titrated to 120 mg in participants with T2DM
The dose will be titrated over 12 weeks, starting with a dose of 5 mg BID to reach the target dose of 120 mg BID. Titration steps include: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID
干预措施: PF-06882961 (Drug)
Arm 2-PF-06882961 starting dose of 10 mg BID titrated to 100 mg in participants with T2DM
The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 120 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID
干预措施: PF-06882961 (Drug)
Arm 3-PF-06882961 starting dose of 5 mg BID titrated to 80 mg in participants with T2DM
The dose will be titrated over 12 weeks, starting with a dose of 5 mg BID to reach the target dose of 80 mg BID. Titration steps include: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID
干预措施: PF-06882961 (Drug)
Arm 4-PF-06882961 starting dose of 10 mg BID titrated to 80 mg in participants with T2DM
The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 80 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID
干预措施: PF-06882961 (Drug)
Arm 5 - Placebo in subjects with T2DM and Obesity
Matching Placebo tablets taken twice a day (BID)
干预措施: Placebo (Other)
Arm 6-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with T2DM
The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 200 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 MG BID, 200 mg BID
干预措施: PF-06882961 (Drug)
Arm 7-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with Obesity
The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 200 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 MG BID, 200 mg BID
干预措施: PF-06882961 (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
时间窗: Baseline through follow-up (Day 112)
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE. Assessments of AE intensity were defined as mild (easily tolerated, causing minimal discomfort and not interfering with daily activities), moderate (causing sufficient discomfort and interferes with normal daily activities) and severe (preventing normal daily activities).
次要结局
- Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization Criteria(Baseline through Visit 10 (Day 91))
- Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)(Baseline through Visit 10 (Day 91))
- CFB in Fasting Plasma Glucose at Week 6(Baseline, Week 6)
- CFB in Glycolated HbA1c at Week 10(Baseline, Week 10)
- Change From Baseline (CFB) in Fasting Plasma Glucose at Week 2(Baseline, Week 2)
- Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)(Week 0, 2, 4, 6, 8, 10, 12, 13-14)
- CFB in Fasting Plasma Glucose at Week 4(Baseline, Week 4)
- CFB in Glycolated HbA1c at Week 4(Baseline, Week 4)
- Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria(Baseline through Visit 10 (Day 91))
- CFB in Fasting Plasma Glucose at Week 10(Baseline, Week 10)
- CFB in Glycolated HbA1c at Week 8(Baseline, Week 8)
- CFB in Body Weight at Week 4 (Participants With T2DM)(Baseline, Week 4)
- CFB in Body Weight at Week 6 (Participants With T2DM)(Baseline, Week 6)
- Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)(Week 0, 2, 4, 6, 8, 10, 12, 13-14.)
- CFB in Fasting Plasma Glucose at Week 8(Baseline, Week 8)
- CFB in Fasting Plasma Glucose at Week 12(Baseline, Week 12)
- CFB in Glycolated Hemoglobin A1c (HbA1c) at Week 2(Baseline, Week 2)
- CFB in Glycolated HbA1c at Week 12(Baseline, Week 12)
- CFB in Body Weight at Week 2 (Participants With T2DM)(Baseline, Week 2)
- CFB in Body Weight at Week 10 (Non-diabetic Participants With Obesity)(Baseline, Week 10)
- CFB in Glycolated HbA1c at Week 6(Baseline, Week 6)
- CFB in Body Weight at Week 8 (Participants With T2DM)(Baseline, Week 8)
- CFB in Body Weight at Week 6 (Non-diabetic Participants With Obesity)(Baseline, Week 6)
- CFB in Body Weight at Week 8 (Non-diabetic Participants With Obesity)(Baseline, Week 8)
- CFB in Body Weight at Week 12 (Non-diabetic Participants With Obesity)(Baseline, Week 12)
- CFB in Body Weight at Week 10 (Participants With T2DM)(Baseline, Week 10)
- CFB in Body Weight at Week 2 (Non-diabetic Participants With Obesity)(Baseline, Week 2)
- CFB in Body Weight at Week 4 (Non-diabetic Participants With Obesity)(Baseline, Week 4)
- CFB in Body Weight at Week 12 (Participants With T2DM)(Baseline, Week 12)