Extension Study of Gelesis100 on Body Weight

NCT03021291 | Completed DMC FDA Device

• 1 other identifier: GS-100-009
• Study Type: interventional
• Target: 36
• Locations: 5 countries
• Sites: 16

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• 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 (5)

• 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

  Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

• Change in insulin resistance

  Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

• Change in glycosylated hemoglobin (HbA1c)

  Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

• Change in body mass index (BMI)

  Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

Other Outcomes (30)

• Body weight responders (10%)

  Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

• Change in excess body weight

  Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

• Change in body weight status (normal, overweight, obese)

  Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

Study Arms (1)

Gelesis100

EXPERIMENTAL

Gelesis100 (2.25 g) twice daily

Device: Gelesis100 (2.25 g)

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.

Gelesis100

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Gelesis, Inc.: lead

Study Sites (16)

Arternis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Clinical Trial Investigators

Tustin, California, 92780, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Westside Center for Clinical Research

Jacksonville, Florida, 32205, United States

Location

Pennington Biomedical Research

Baton Rouge, Louisiana, 70808, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Cornell Weill Medical College

New York, New York, 10065, United States

Location

Radiant Research

Cincinnati, Ohio, 45249, United States

Location

Aventiv Research

Columbus, Ohio, 43213, United States

Location

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

Texas Diabetes and Endocrinology

Round Rock, Texas, 78681, United States

Location

Health & Care SRO

Prague, 182 00, Czechia

Location

University of Cophenhagen

Copenhagen, DK-1958, Denmark

Location

IRCCS Policlinico San Donato

Milan, 20097, Italy

Location

University of Rome

Rome, 00186, Italy

Location

University of Navarra

Pamplona, 31008, Spain

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hassan Heshmati, MD

  Gelesis, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 13, 2017
• Study Start: January 25, 2017
• Primary Completion: December 8, 2017
• Study Completion: December 15, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

CZ (1); ES (1); DK (1); US (11); IT (2)