NCT05579977终止2 期
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, DOSE RANGING, DOSE FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-07081532, AND OPEN LABEL ORAL SEMAGLUTIDE, IN ADULTS WITH TYPE 2 DIABETES MELLITUS (T2DM) INADEQUATELY CONTROLLED ON METFORMIN, AND SEPARATELY PF-07081532 COMPARED TO MATCHING PLACEBO IN ADULTS WITH OBESITY BUT WITHOUT T2DM
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 902
- 试验地点
- 86
- 主要终点
- Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)
研究概览
简要总结
The purpose of this study is to find out if PF-07081532 ("the active study drug"), is safe and helps treat people with obesity without diabetes to lose weight, and people with diabetes to keep their blood sugar in good control. Individuals diagnosed with diabetes that are on metformin or individuals with obesity without diabetes will be included in the study.
Those participating in the diabetes part of the study, will receive either active study drug, placebo, or an approved treatment called Rybelsus. Those in the obesity part of the study, will receive either active study drug or placebo. The study will last for about 36 weeks except for the first 25% of the participants that enter in which case the study will last for approximately 48 weeks. during this time there will be visits every 4 weeks with phone calls in between.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •T2DM inadequately controlled with metformin
- •BMI ≥23.0 kg/m2 (≥20.0 kg/m2 in Japan)
- •HbA1C of 7% to 10% (53-86 mmol/mol)
- •FPG ≤270 mg/dL (15 mmol/L)
- •BMI ≥30.0 kg/m2
- •HbA1C ≤6.4% (47 mmol/mol)
- •FPG ≤126 mg/dL (7 mmol/L)
排除标准
- •Any of the following: Active/current, symptomatic gallbladder disease; History of pancreatitis in the prior 2-months;History of Type 1 Diabetes Mellitus, or secondary forms of diabetes; Any condition affecting drug absorption; Medical history of active liver disease (other than non-alcoholic hepatic steatosis)
- •Use of pharmacological agents with approved indication for weight loss
- •T2DM:Use of any agent (other than metformin)for the explicit purpose of glycemic control;History of diabetic ketoacidosis;Proliferative retinopathy or maculopathy requiring acute treatment;
- •Obesity: Previous or planned weight reduction surgery; Major depressive disorder or other severe psychiatric disorders; Any lifetime history of a suicide attempt; PHQ-9 score ≥15; Response of "yes" to Question 4 or 5, or on any suicidal behavioral question on the C-SSRS
- •Clinically significant cardiovascular conditions
- •Uncontrolled blood pressure
- •Personal or within first-degree relative family history of MTC or MEN2
- •Other medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
- •Any of the following central lab results: Fasting C-peptide <0.8 ng/mL; ALT or AST ≥2.5x ULN; Direct bilirubin >ULN or T Bili >1.5x ULN except when participants have a history of Gilbert syndrome ; TSH >1.5x ULN or <LLN; Serum calcitonin >ULN; Serum amylase or serum lipase >ULN; eGFR <45 ml/min/1.73 ; Active Hepatitis B, or Hepatitis C; A positive urine drug test for illicit drugs
研究组 & 干预措施
PF-07081532 20 mg T2DM
Experimental
PF-07081532 20 mg daily in T2DM
干预措施: PF-07081532 (Drug)
PF-07081532 40 mg T2DM
Experimental
PF-07081532 40 mg daily in T2DM
干预措施: PF-07081532 (Drug)
PF-07081532 80 mg T2DM
Experimental
PF-07081532 80 mg daily in T2DM
干预措施: PF-07081532 (Drug)
PF-07081532 160 mg T2DM
Experimental
PF-07081532 160 mg daily in T2DM
干预措施: PF-07081532 (Drug)
PF-07081532 260 mg T2DM
Experimental
PF-07081532 260 mg daily in T2DM
干预措施: PF-07081532 (Drug)
Placebo T2DM
Placebo Comparator
Placebo daily in T2DM
干预措施: Placebo (Other)
PF-07081532 80 mg Obesity
Experimental
PF-07081532 80 mg daily in Obesity
干预措施: PF-07081532 (Drug)
PF-07081532 140 mg Obesity
Experimental
PF-07081532 140 mg daily in Obesity
干预措施: PF-07081532 (Drug)
PF-07081532 200 mg Obesity (Option 1)
Experimental
PF-07081532 200 mg daily in Obesity
干预措施: PF-07081532 (Drug)
PF-07081532 200 mg Obesity (Option 2)
Experimental
PF-07081532 200 mg daily in Obesity
干预措施: PF-07081532 (Drug)
PF-07081532 260 mg Obesity
Experimental
PF-07081532 260 mg daily in Obesity
干预措施: PF-07081532 (Drug)
Rybelsus 14 mg T2DM
Active Comparator
Semaglutide 14 mg daily in T2DM
干预措施: Rybelsus (Drug)
Placebo Obesity
Placebo Comparator
Placebo in Obesity
干预措施: Placebo (Other)
结局指标
主要结局
Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)
时间窗: Baseline (result closest prior to dosing on Day 1), Week 32
Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 32: Cohort 2 (Obesity)
时间窗: Baseline (result closest prior to dosing on Day 1), week 32
Body weight was measured using a calibrated weighing scale.
次要结局
- Percentage of Participants Who Achieved HbA1C <7% at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)(Baseline (result closest prior to dosing on Day 1), Week 32)
- Percent Change From Baseline in Body Weight at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)(Baseline (result closest prior to dosing on Day 1), Week 32)
- Absolute Change From Baseline in Waist-to-hip Ratio at Week 32: Cohort 2 (Obesity)(Baseline (result closest prior to dosing on Day 1), Week 32)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 1 (Type 2 Diabetes Mellitus)(From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28))
- Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 32: Cohort 2 (Obesity)(Baseline (result closest prior to dosing on Day 1), Week 32)
- Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS) Category: Cohort 2 (Obesity) Only(Baseline (result closest prior to dosing on Day 1), anytime post-baseline (Up to Week 28))
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)(Baseline (result closest prior to dosing on Day 1), Week 32)
- Number of Participants With Serious Adverse Events (SAEs): Cohort 2 (Obesity)(From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28))
- Number of Participants With Vital Sign Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)(Up to week 28)
- Number of Participants With Clinical Laboratory Abnormalities: Cohort 2 (Obesity)(Up to week 28)
- Placebo-adjusted, Change From Baseline in HbA1C in the Rybelsus Arm at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)(Baseline (result closest prior to dosing on Day 1), Week 32)
- Percentage of Participants Achieving >=5%, >=10%, and >=15% Body Weight Loss at Week 32 Relative to Baseline: Cohort 2 (Obesity)(Baseline (result closest prior to dosing on Day 1), Week 32)
- Absolute Change From Baseline in Waist Circumference at Week 32: Cohort 2 (Obesity)(Baseline (result closest prior to dosing on Day 1), Week 32)
- Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 32: Cohort 2 (Obesity)(Baseline (result closest prior to dosing on Day 1), Week 32)
- Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 1 (Type 2 Diabetes Mellitus)(From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28))
- Number of Participants With Hypoglycemic Adverse Events (HAE) According to Titration Dose: Cohort 1 (Type 2 Diabetes Mellitus)(Up to week 28)
- Number of Participants With Hypoglycemic Adverse Events According to Titration Dose: Cohort 2 (Obesity)(Up to week 28)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 2 (Obesity)(From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28))
- Number of Participants With Serious Adverse Events (SAEs): Cohort 1 (Type 2 Diabetes Mellitus)(From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28))
- Number of Participants With Vital Sign Abnormalities: Cohort 2 (Obesity)(Up to week 28)
- Number of Participants With Clinical Laboratory Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)(Up to week 28)
- Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 2 (Obesity)(From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28))
- Number of Participants With ECG Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)(Up to week 28)
- Number of Participants With ECG Abnormalities: Cohort 2 (Obesity)(Up to week 28)
研究者
研究点 (86)
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