A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF-08653944 IN ADULTS WITH OVERWEIGHT OR OBESITY (VESPER-6)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 954
- 试验地点
- 67
- 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 the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes.
About 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe.
People will take part in this study for about 20 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
- Double (Participant, 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: ≥30 kg/m2 or ≥27.0 kg/m2 to <30.0 kg/m2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.
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
Treatment Arm 4
Participants will receive PF-08653944 by Subcutaneous Injection.
干预措施: PF-08653944 (Drug)
Placebo
Participants will receive matching placebo by Subcutaneous Injection.
干预措施: Placebo (Other)
Treatment Arm 1
Participants will receive PF-08653944 by Subcutaneous Injection.
干预措施: PF-08653944 (Drug)
Treatment Arm 2
Participants will receive PF-08653944 by Subcutaneous Injection.
干预措施: PF-08653944 (Drug)
Treatment Arm 3
Participants will receive PF-08653944 by Subcutaneous Injection.
干预措施: PF-08653944 (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
- 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)
- Percent change from baseline in body weight in participants with type 2 diabetes(Baseline, Week 72)
- Change from baseline in body weight(Baseline, Week 72)
- Change from baseline in waist circumference(Baseline, Week 72)
- Percentage of Participants achieving ≥10% of body weight reduction from baseline(Baseline, Week 72)
- Change from baseline in Systolic Blood Pressure (SBP)(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)
- Percentage of Participants achieving ≥25% of body weight reduction from baseline(Baseline, Week 72)
- Change from baseline in Diastolic Blood Pressure (DBP)(Baseline, Week 72)
- Change from Baseline in Fasting Glucose(Basline, 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)
- 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 Short Form 36 health survey (SF-36) domain scales and component summary scales(Baseline, Week 72)
- Change from Baseline in Control of Eating Questionnaire (CoEQ) subscales(Baseline, Week 72)
- Change from Baseline in Food Noise Questionnaire (FNQ) total score(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 avents leading to discontinuation(Baseline, Week 72)
- Number of Participants with Adverse Events of Special Interest (AESIs)(Baseline, Week 72)
- Percentage of Participants with a waist-to-height ratio of <0.53(Baseline, Week 72)