2026-525318-75-00招募中3 期
C6491013 - 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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 120
- 试验地点
- 17
- 主要终点
- Body weight percent change from baseline (CFB) at Week 72.
研究概览
简要总结
To demonstrate the superiority for each dose of PF-08653944 QM versus placebo for reducing body weight at Week 72.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening.
- •Have a BMI at Screening of: a. ≥30 kg/m2 (may or may not have the weight-related co-morbidities listed below) OR b. ≥27.0 kg/m2 to <30.0 kg/m2 and must have at least 1 of the following weightrelated co-morbidities either previously diagnosed or diagnosed at Screening: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.
排除标准
- •Participant has a self-reported body weight change [increase or decrease] in body weight greater than 5% within 90 days prior to Screening.
- •Diagnosis of type 1 diabetes or any other form of diabetes other than T2D (resolved gestational diabetes is permitted)
- •History of acute or chronic pancreatitis. Participants with gallstone-associated pancreatitis who have undergone cholecystectomy are eligible for this trial.
- •Personal or family history (first-degree relatives) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).
研究组 & 干预措施
PF-08653944, PF-08653944, PF-08653944, PF-08653944
Test
干预措施: PF-08653944 (Drug)
Placebo to match PF-08653944
Placebo
干预措施: Placebo to match PF-08653944 (Drug)
结局指标
主要结局
Body weight percent change from baseline (CFB) at Week 72.
Body weight percent change from baseline (CFB) at Week 72.
次要结局
- IWQoL-Lite-CT Physical Function composite score CFB at Week 72.
- Body weight (kg) CFB at Week 72.
- Waist circumference (cm) CFB at Week 72.
- SBP (mmHg) CFB at Week 72.
研究者
Clinical Medical Lead
Scientific
Pfizer Inc.
研究点 (17)
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