Extension Study of Gelesis100 on Body Weight

Gelesis, Inc.36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Overweight and Obesity

Interventions

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.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (16)

Arternis Institute for Clinical Research

San Diego, California, United States

Clinical Trial Investigators

Tustin, California, United States