A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-WEEKLY BEROBENATIDE IN ADULTS WITH OBESITY DISEASE IN JAPAN (VESPER-JW)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Pfizer
- 入组人数
- 180
- 试验地点
- 14
- 主要终点
- Percent change from baseline in body weight
研究概览
简要总结
The purpose of this clinical study is to learn about safety and effects of berobenatide (PF-08653944) in adults with obesity disease, a condition where a person has too much body fat, which can harm their health and increase the risk of other medical problems. Some people in this study may also have type 2 diabetes, a condition in which the body does not use insulin properly, causing blood sugar levels to become too high.
This study is seeking participants in Japan who:
- Have obesity disease.
- May have type 2 diabetes.
- Meet the study-specific age, weight and health requirements.
About 180 adults will take part in this study. Participants will be randomly assigned to receive either berobenatide or a placebo. A placebo looks like the study medicine but does not contain any active medicine.
Berobenatide or placebo will be given as an injection under the skin of the abdomen (belly area). The study will compare the experiences of people receiving berobenatide with those receiving placebo to determine whether berobenatide can help people lose weight. The study will also assess the safety of berobenatide and its effects on body weight and other health measures.
People will take part in this study for about 22 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years.
- •BMI of: ≥27.0 kg/m2 to <35.0 kg/m2 with ≥2 obesity-related health disorders or BMI of ≥35.0 kg/m2 with ≥1 obesity-related health disorder. The participant must have at least one of either hypertension, dyslipidemia or glucose intolerance (T2D and impaired glucose tolerance etc.) as an obesity-related health disorder.
排除标准
- •Have a self-reported body weight change greater than 5% within 90 days prior to Screening.
- •Diagnosis of type 1 diabetes or any other form of diabetes other than T2D.
- •History of acute or chronic pancreatitis.
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).
研究组 & 干预措施
Placebo
Participants will receive placebo solution for injection as subcutaneous injection.
干预措施: Placebo (Other)
Treatment Arm 1
Participants will receive berobenatide solution for injection as subcutaneous injection.
干预措施: Berobenatide (Drug)
Treatment Arm 2
Participants will receive berobenatide solution for injection as subcutaneous injection.
干预措施: Berobenatide (Drug)
Treatment Arm 3
Participants will receive berobenatide solution for injection as subcutaneous injection.
干预措施: Berobenatide (Drug)
结局指标
主要结局
Percent change from baseline in body weight
时间窗: Baseline, Week 72
次要结局
- Change from baseline in waist circumference(Baseline, Week 72)
- Percentage of Participants achieving ≥10% of body weight reduction from baseline(Baseline, Week 72)
- Percentage of Participants achieving ≥15% of body weight reduction from baseline(Baseline, Week 72)
- Percentage of Participants achieving ≥20% of body weight reduction from baseline(Baseline, Week 72)
- Percentage of Participants achieving ≥5% of body weight reduction from baseline(Baseline, Week 72)
- Change from baseline in body weight(Baseline, Week 72)
- Change from baseline in Systolic Blood Pressure (SBP)(Baseline, Week 72)
- Change from baseline in Diastolic Blood Pressure (DBP)(Baseline, Week 72)
- Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score(Baseline, Week 72)
- Change from baseline in IWQoL-Lite-CT total score(Baseline, Week 72)
- Change from baseline in IWQoL-Lite-CT Physical composite score(Baseline, Week 72)
- Change from baseline in IWQoL-Lite-CT Psychosocial composite score(Baseline, Week 72)
- Change from Baseline in Fasting Plasma Glucose(Baseline, Week 72)
- Change from Baseline in Fasting Insulin(Baseline, Week 72)
- Change from Baseline in revised Homeostatic Model Assessment insulin sensitivity as a percentage of normal (HOMA2-%S)(Baseline, Week 72)
- Change from Baseline in revised Homeostatic Model Assessment beta-cell function as a percentage of a normal reference population (HOMA2-%B)(Baseline, Week 72)
- Change from Baseline in HbA1c(Baseline, Week 72)
- Change from baseline in Fasting Total Cholesterol(Baseline, Week 72)
- Change from baseline in Fasting Low-density lipoprotein cholesterol(Baseline, Week 72)
- Change from baseline in Fasting Very low-density lipoprotein cholesterol(Baseline, Week 72)
- Change from baseline in Fasting Non-High-density lipoprotein cholesterol(Baseline, Week 72)
- Change from baseline in Fasting High-density lipoprotein cholesterol(Baseline, Week 72)
- Change from baseline in Fasting triglycerides(Baseline, Week 72)
- Change from baseline in high-sensitivity C-reactive protein(Baseline, Week 72)
- Change from baseline in interleukin-6(Baseline, Week 72)
- Change from baseline in interleukin-1 beta(Baseline, Week 72)
- Number of Participants with Treatment Emergent Adverse Events (TEAEs)(Baseline, Week 72)
- Number of Participants with Serious Adverse Events (SAEs)(Baseline, Week 72)
- Number of Participants with adverse events leading to discontinuation(Baseline, Week 72)
- Number of Participants with Adverse Events of Special Interest (AESIs)(Baseline, Week 72)
- Number of participants with absolute and change from baseline in laboratory measurements(Baseline, Week 72)
- Change from baseline in visceral fat area(Baseline, Week 72)
- Percentage of participants achieving the conversion to normoglycemia(Baseline, Week 72)
- Change from Baseline in Oral Glucose Tolerance Test (OGTT) 2h(Baseline, Week 72)
- Percentage of participants achieving conversion from HbA1c ≥7% to HbA1c <7%(Baseline, Week 72)
- Percentage of participants achieving conversion from >6.5% to HbA1c ≤6.5%(Baseline, Week 72)
- Percentage of participants achieving conversion from HbA1c ≥5.7% to HbA1c <5.7%(Baseline, Week 72)