Extension Study of Gelesis100 on Body Weight

Overweight and Obesity Clinical Trial

— GLOW-EX  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021291
• Other study ID #: GS-100-009
• Status: Completed
• Phase: N/A
• First received: January 12, 2017
• Last updated: February 15, 2018
• Start date: January 25, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: February 2018
• Source: Gelesis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 15, 2017
• Est. primary completion date: December 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gelesis, Inc.

Countries where clinical trial is conducted

United States,  Czechia,  Denmark,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change in excess body weight	Change from baseline (%)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Other	Change in body weight status (normal, overweight, obese)		Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Change in serum potassium	Change from baseline (mmol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Other	Change in serum chloride	Change from baseline (mmol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Other	Change in serum calcium	Change from baseline (mmol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Other	Change in serum magnesium	Change from baseline (mmol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Other	Change in serum phosphorus	Change from baseline (mmol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Other	Change in serum glucose	Change from baseline (mmol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Other	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
Other	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
Other	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
Other	Change in total bilirubin	Change from baseline (umol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Change in serum albumin	Change from baseline (g/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Other	Change in hematocrit	Change from baseline (%)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Other	Change in hemoglobin	Change from baseline (mmol/L)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Primary	Change in body weight	Percent (%) change from baseline	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Primary	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	Change in plasma glucose status (normal, impaired, diabetic)		Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Secondary	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
Secondary	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
Secondary	Change in glycosylated hemoglobin (HbA1c)	Change from baseline (%)	Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Secondary	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