A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of GSP3 on Body Weight in Overweight and Obese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 5
- 主要终点
- Change in Body Weight
研究概览
简要总结
The FLOW (First Loss Of Weight) study is designed to assess the effects of repeated administration of GSP3, an investigational product, on body weight. It is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study. FLOW is being conducted in 5 medical centers in Italy, Czech Republic, and Denmark, and will randomize 123 overweight and obese adult males and females to receive either placebo, GSP3 (2.25g), or GSP3 (3.75g) in addition to a hypocaloric diet (-600 kcal/day) for 12 weeks.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) ≥ 27 and ≤ 35 (at least 30% overweight and 30% obese subjects)
- •Ability to follow verbal and written instructions
- •Informed Consent Form signed by the subjects
排除标准
- •Pregnancy or lactation
- •Absence of medically approved contraceptive methods in females of childbearing potential (e.g., hysterectomy, non-oral contraceptive medications or intrauterine device combined with a barrier method, two combined barrier methods such as diaphragm and condom or spermicide; bilateral tubal ligation and vasectomy are not acceptable contraceptive methods)
- •History of allergic reaction to carboxymethylcellulose, citric acid, modified cellulose, microcrystalline cellulose, and gelatin
- •Administration of investigational products within 1 month prior to Screening Visit
- •Night-shift workers
- •Subjects who stopped smoking within 6 months prior to Screening Visit or considering smoking cessation during the study
- •Subjects anticipating surgical intervention during the study
- •Known type 1 or type 2 diabetes
- •History of eating disorders including binge eating (except mild binge eater)
- •Weight change > 3 kg within 3 months prior to and during the Screening period
- •Supine systolic blood pressure (SBP) > 150 mm Hg and/or supine diastolic blood pressure (DBP) > 90 mm Hg
- •Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
- •History of gastroesophageal reflux disease
- •History of gastric or duodenal ulcer
- •History of gastroparesis
- •History of gastric bypass or any other gastric surgery
- •History of intragastric balloon
- •History of pancreatitis
- •History of hemorrhoids
- •History of malabsorption
- •Laxative users
- •History of hepatitis B or C
- •History of human immunodeficiency virus
- •History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
- •Any other clinically significant disease interfering with the assessments of Attiva, according to the Investigator
- •Positive serum or urine pregnancy test(s) in females of childbearing potential
- •Plasma glucose ≥ 126 mg/dL (7.0 mmol/L)
- •Abnormal serum thyrotropin (TSH)
- •Serum triglycerides > 500 mg/dL (5.65 mmol/L)
- •Positive test for drugs in the urine
- •Any relevant biochemical abnormality interfering with the assessments of Attiva, according to the Investigator
- •Anti-obesity medications (including herbal preparations) within 1 month prior to Screening Visit
- •Systemic corticosteroids within 1 month prior to Screening Visit
- •Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month)
- •Any other medication known to cause weight loss or weight gain within 1 month prior to Screening Visit
- •Medications treating hypertension within 1 month prior to Screening Visit
- •Medications treating dyslipidemia within 1 month prior to Screening Visit
- •Anticipated requirement for use of prohibited concomitant medications
研究组 & 干预措施
Placebo
Microcyrstalline cellulose (Avicel): provided in 5 capsules (350 mg each), twice daily (BID) prior to lunch and dinner.
干预措施: Avicel (modified Cellulose) (Dietary Supplement)
GSP3 (2.25g)
GSP3: provided in 3 capsules (750 mg each), plus 2 placebo capsules (350 mg each), twice daily (BID) prior to lunch and dinner
干预措施: GSP3 (Device)
GSP3 (2.25g)
GSP3: provided in 3 capsules (750 mg each), plus 2 placebo capsules (350 mg each), twice daily (BID) prior to lunch and dinner
干预措施: Avicel (modified Cellulose) (Dietary Supplement)
GSP3 (3.75g)
GSP3: provided in 5 capsules (750 mg each), twice daily (BID) prior to lunch and dinner
干预措施: GSP3 (Device)
结局指标
主要结局
Change in Body Weight
时间窗: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Change from baseline in kilograms and percent (%) weight
次要结局
- Change in appetite (hunger, satiety, and fullness)(Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14))
- Change in food intake(Measured at weeks 0 and 12)
- Body weight responders(12 weeks)
- Change in waist circumference(Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14))
- Change in fat mass(Measured at weeks 0 and 13)
- Change in bone-free fat mass(Measured at weeks 0 and 13)