Extension Study of Gelesis100 on Body Weight
Status: | Completed |
---|---|
Conditions: | Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 22 - 65 |
Updated: | 2/23/2018 |
Start Date: | January 25, 2017 |
End Date: | December 15, 2017 |
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)
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.
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.
Inclusion Criteria:
1. Completion of the GLOW study with at least 3% weight loss
2. Informed Consent Form signed by the subjects at the end of the GLOW study
Exclusion Criteria:
1. Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing
potential) or lactation
2. 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)
3. Subjects considering smoking cessation during the study
4. Subjects anticipating surgical intervention during the study
5. Significant intolerance to the study product during the GLOW study
6. 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)
7. 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)
8. 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
9. Poor subject compliance with the GLOW study procedures and recommendations and/or
major protocol deviation
10. Anticipated requirement for use of prohibited concomitant medications
We found this trial at
12
sites
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1 Boston Medical Center Place
Boston, Massachusetts 02118
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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