Extension Study of Gelesis100 on Body Weight

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Device: Gelesis100 (2.25 g)

• Registration Number: NCT03021291
• Lead Sponsor: Gelesis, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Study Start: 2017-01-25
• Primary Completion: 2017-12-08
• Study Completion: 2017-12-15
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gelesis100	Gelesis100 (2.25 g)	Gelesis100 (2.25 g) twice daily

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in plasma glucose	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339	Change from baseline in millimoles per liter (mmol/L)
Change in insulin resistance	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339	Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR)
Change in glycosylated hemoglobin (HbA1c)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339	Change from baseline (%)
Change in body mass index (BMI)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339	Measured as body weight in kilograms divided by height in meters-squared (kg/m2)
Change in plasma glucose status (normal, impaired, diabetic)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

Trial Locations

Locations (16)

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Clinical Trial Investigators; 🇺🇸 Tustin, California, United States

Arternis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

Texas Diabetes and Endocrinology; 🇺🇸 Round Rock, Texas, United States

Geisinger Health System; 🇺🇸 Danville, Pennsylvania, United States

University of Rome; 🇮🇹 Rome, Italy

Westside Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Aventiv Research; 🇺🇸 Columbus, Ohio, United States

Pennington Biomedical Research; 🇺🇸 Baton Rouge, Louisiana, United States

University of Cophenhagen; 🇩🇰 Copenhagen, Denmark

Health & Care SRO; 🇨🇿 Prague, Czechia

Boston University Medical Center; 🇺🇸 Boston, Massachusetts, United States

Cornell Weill Medical College; 🇺🇸 New York, New York, United States

IRCCS Policlinico San Donato; 🇮🇹 Milan, Italy

University of Navarra; 🇪🇸 Pamplona, Spain

Radiant Research; 🇺🇸 Cincinnati, Ohio, United States