Extension Study of Gelesis100 on Body Weight (GLOW-EX)

An Open-label Study Assessing the Effect of Gelesis100 on Weight Loss and Weight Maintenance in Overweight and Obese Subjects Who Completed the GLOW Study (G-04)

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 Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Device: Gelesis100 (2.25 g)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 182 00
    • Health & Care SRO
• Denmark
  • Copenhagen, Denmark, DK-1958
    • University of Cophenhagen
• Italy
  • Milan, Italy, 20097
    • IRCCS Policlinico San Donato
  • Rome, Italy, 00186
    • University of Rome
• Spain
  • Pamplona, Spain, 31008
    • University of Navarra
• United States
  • California
    • San Diego, California, United States, 92103
      • Arternis Institute for Clinical Research
    • Tustin, California, United States, 92780
      • Clinical Trial Investigators
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Florida
    • Jacksonville, Florida, United States, 32205
      • Westside Center for Clinical Research
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center
  • New York
    • New York, New York, United States, 10065
      • Cornell Weill Medical College
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research
    • Columbus, Ohio, United States, 43213
      • Aventiv Research
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Health System
  • Texas
    • Round Rock, Texas, United States, 78681
      • Texas Diabetes and Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gelesis100; Gelesis100 (2.25 g) twice daily	Device: Gelesis100 (2.25 g); Three capsules of Gelesis100, each containing a 750 mg mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in insulin resistance	Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in glycosylated hemoglobin (HbA1c)	Change from baseline (%)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in body mass index (BMI)	Measured as body weight in kilograms divided by height in meters-squared (kg/m2)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

Other Outcome Measures

Outcome Measure	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 (%)	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
Change in waist circumference	Change from baseline in waist circumference (centimeters)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum insulin	Change from baseline in milliunits per liter (mU/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum C-reactive protein (CRP)	Measured in milligrams per liter (mg/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in total cholesterol, serum low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol/HDL ratio, and triglycerides	measured in milligrams per deciliter (mg/dL)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change vital signs: heart rate, supine and standing systolic and diastolic blood pressure (SBP, DBP)	Measured in beats per minute (heart rate) or millimeters of mercury (mmHg) for blood pressure	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in food intake	Assessed by 24 hr dietary recall	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in Impact of Weight on Quality Of Life (IWQOL)	Change in global and individual questionnaire subscale scores	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
All adverse events (AE), serious adverse events (SAE), and gastrointestinal symptoms	Number and % of subjects with AE/SAEs spontaneously reported; gastrointestinal symptoms solicited via questionnaire.	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum sodium	Change from baseline in millimoles per liter (mmol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum potassium	Change from baseline (mmol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum chloride	Change from baseline (mmol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum calcium	Change from baseline (mmol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum magnesium	Change from baseline (mmol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum phosphorus	Change from baseline (mmol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum glucose	Change from baseline (mmol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in blood urea nitrogen (BUN)	Change from baseline (mmol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum creatinine	Change from baseline in micromoles per liter (umol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum uric acid	Change from baseline (umol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in total bilirubin	Change from baseline (umol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in alanine aminotransferase (ALT)	Change from baseline in international units per liter (IU/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in aspartate transaminase (AST)	Change from baseline (IU/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in gamma-glutamyl transpeptidase (GGT)	Change from baseline (IU/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in alkaline phosphatase (ALP)	Change from baseline (IU/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum total protein	Change from baseline (g/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum albumin	Change from baseline (g/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in hematocrit	Change from baseline (%)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in hemoglobin	Change from baseline (mmol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

Collaborators and Investigators

• Sponsor: Gelesis, Inc.
• Investigators: Study Director: Hassan Heshmati, MD, Gelesis, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2017
• Primary Completion (Actual): December 8, 2017
• Study Completion (Actual): December 15, 2017

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 15, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: GS-100-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No