Extension Study of Gelesis100 on Body Weight | NCT03021291

NCT03021291

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Gelesis100	Experimental	Gelesis100 (2.25 g) twice daily	Device: Gelesis100 (2.25 g)

Name	Type	Description	Arm Group Labels	Other Names
Gelesis100 (2.25 g)	Device	Three capsules of Gelesis100, each containing a 750 mg mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in body weight	Percent (%) change from baseline	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Body weight responders (5%)	Change from baseline in body weight of at least 5%	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

Secondary Outcomes

Measure	Description	Time Frame
Change in plasma glucose status (normal, impaired, diabetic)		Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in plasma glucose	Change from baseline in millimoles per liter (mmol/L)

Other Outcomes

Measure	Description	Time Frame
Body weight responders (10%)	Change from baseline in body weight of at least 10%	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in excess body weight	Change from baseline (%)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Facility	Status	City	State	ZIP	Country	Contacts
Arternis Institute for Clinical Research		San Diego	California	92103	United States
Clinical Trial Investigators

Type	Date	Date Unknown
Release	Nov 11, 2019
Reset	Dec 2, 2019

ID	Term
D050177	Overweight
D009765	Obesity

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight