Extension Study of Gelesis100 on Body Weight

Completed · Not applicable

Conditions studied: Overweight and Obesity

In brief

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.

Key facts

Study ID

NCT03021291

Run by

Gelesis, Inc.

People needed

36

Starts

2017-01-25

Expected to finish

2017-12-15

Last updated by the study team

2018-02-22

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arternis Institute for Clinical Research — San Diego, California, United States
• Clinical Trial Investigators — Tustin, California, United States
• University of Colorado — Aurora, Colorado, United States
• Westside Center for Clinical Research — Jacksonville, Florida, United States
• Pennington Biomedical Research — Baton Rouge, Louisiana, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Cornell Weill Medical College — New York, New York, United States
• Radiant Research — Cincinnati, Ohio, United States
• Aventiv Research — Columbus, Ohio, United States
• Geisinger Health System — Danville, Pennsylvania, United States
• Texas Diabetes and Endocrinology — Round Rock, Texas, United States
• Health & Care SRO — Prague, Czechia
• University of Cophenhagen — Copenhagen, Denmark
• IRCCS Policlinico San Donato — Milan, Italy
• University of Rome — Rome, Italy
• University of Navarra — Pamplona, Spain

Full record on ClinicalTrials.gov

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