NCT03021291已完成不适用
An Open-label Study Assessing the Effect of Gelesis100 on Weight Loss and Weight Maintenance in Overweight and Obese Subjects Who Completed the GLOW Study (G-04)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 31
- 主要终点
- Change in body weight
研究概览
简要总结
This study is designed to assess the effect of Gelesis100 on body weight after an additional exposure of 24 weeks in subjects who completed the 24-week treatment period, and had at least 3% weight loss, in the Gelesis Loss Of Weight GLOW, NCT02307279) study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the GLOW study with at least 3% weight loss
- •Informed Consent Form signed by the subjects at the end of the GLOW study
排除标准
- •Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) 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, or condom and spermicide; bilateral tubal ligation and vasectomy are not acceptable contraceptive methods)
- •Subjects considering smoking cessation during the study
- •Subjects anticipating surgical intervention during the study
- •Significant intolerance to the study product during the GLOW study
- •Increase of ≥ 0.5% point (≥ 5.5 mmol/mol) in HbA1c from the Baseline Visit of the GLOW study in subjects with treated or untreated type 2 diabetes if considered clinically relevant, or any increase if HbA1c is > 8.5% (> 69 mmol/mol)
- •Increase of ≥ 10% in total cholesterol, low-density lipoprotein (LDL) cholesterol, or triglycerides from the Baseline Visit of the GLOW study in subjects with elevated lipids at the Baseline Visit of the GLOW study if considered clinically relevant, or any increase if serum LDL cholesterol is ≥ 190 mg/dL (≥ 4.93 mmol/L) and/or serum triglycerides are ≥ 500 mg/dL (≥ 5.65 mmol/L)
- •Increase of ≥ 10 mm Hg in supine systolic blood pressure (SBP) and/or supine diastolic blood pressure (DBP) from the Baseline Visit of the GLOW study in subjects with treated or untreated hypertension if considered clinically relevant, or any increase if supine SBP is > 160 mm Hg and/or supine DBP is > 95 mm Hg, based on the mean of two consecutive readings
- •Poor subject compliance with the GLOW study procedures and recommendations and/or major protocol deviation
- •Anticipated requirement for use of prohibited concomitant medications
研究组 & 干预措施
Gelesis100
Experimental
Gelesis100 (2.25 g) twice daily
干预措施: Gelesis100 (2.25 g) (Device)
结局指标
主要结局
Change in body weight
时间窗: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Percent (%) change from baseline
Body weight responders (5%)
时间窗: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change from baseline in body weight of at least 5%
次要结局
- Change in plasma glucose(Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339)
- Change in insulin resistance(Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339)
- Change in glycosylated hemoglobin (HbA1c)(Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339)
- Change in body mass index (BMI)(Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339)
- Change in plasma glucose status (normal, impaired, diabetic)(Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339)
研究者
研究点 (31)
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