GLOW-EX: Extension Study of Gelesis100 on Body Weight

• Sponsor: Gelesis, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03021291
• Collaborator: (none)
• Enrollment: 36
• Locations: 16
• Arm: 1
• Actual Duration (Months): 10.6
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Device: Gelesis100 (2.25 g)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Jan 25, 2017
• Actual Primary Completion Date: Dec 8, 2017
• Actual Study Completion Date: Dec 15, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in body weight [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

   Percent (%) change from baseline

2. Body weight responders (5%) [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

   Change from baseline in body weight of at least 5%

Secondary Outcome Measures

1. Change in plasma glucose status (normal, impaired, diabetic) [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

2. Change in plasma glucose [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

   Change from baseline in millimoles per liter (mmol/L)

3. Change in insulin resistance [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

   Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR)

4. Change in glycosylated hemoglobin (HbA1c) [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

   Change from baseline (%)

5. Change in body mass index (BMI) [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

   Measured as body weight in kilograms divided by height in meters-squared (kg/m2)

Other Outcome Measures

1. Body weight responders (10%) [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

   Change from baseline in body weight of at least 10%

2. Change in excess body weight [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

   Change from baseline (%)

3. Change in body weight status (normal, overweight, obese) [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

4. Change in waist circumference [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

   Change from baseline in waist circumference (centimeters)

5. Change in serum insulin [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

   Change from baseline in milliunits per liter (mU/L)

6. Change in serum C-reactive protein (CRP) [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

   Measured in milligrams per liter (mg/L)

7. Change in total cholesterol, serum low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol/HDL ratio, and triglycerides [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

   measured in milligrams per deciliter (mg/dL)

8. Change vital signs: heart rate, supine and standing systolic and diastolic blood pressure (SBP, DBP) [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

   Measured in beats per minute (heart rate) or millimeters of mercury (mmHg) for blood pressure

9. Change in food intake [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

   Assessed by 24 hr dietary recall

10. Change in Impact of Weight on Quality Of Life (IWQOL) [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change in global and individual questionnaire subscale scores

11. All adverse events (AE), serious adverse events (SAE), and gastrointestinal symptoms [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Number and % of subjects with AE/SAEs spontaneously reported; gastrointestinal symptoms solicited via questionnaire.

12. Change in serum sodium [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline in millimoles per liter (mmol/L)

13. Change in serum potassium [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline (mmol/L)

14. Change in serum chloride [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline (mmol/L)

15. Change in serum calcium [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline (mmol/L)

16. Change in serum magnesium [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline (mmol/L)

17. Change in serum phosphorus [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline (mmol/L)

18. Change in serum glucose [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline (mmol/L)

19. Change in blood urea nitrogen (BUN) [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline (mmol/L)

20. Change in serum creatinine [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline in micromoles per liter (umol/L)

21. Change in serum uric acid [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline (umol/L)

22. Change in total bilirubin [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline (umol/L)

23. Change in alanine aminotransferase (ALT) [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline in international units per liter (IU/L)

24. Change in aspartate transaminase (AST) [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline (IU/L)

25. Change in gamma-glutamyl transpeptidase (GGT) [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline (IU/L)

26. Change in alkaline phosphatase (ALP) [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline (IU/L)

27. Change in serum total protein [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline (g/L)

28. Change in serum albumin [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline (g/L)

29. Change in hematocrit [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline (%)

30. Change in hemoglobin [Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339]

    Change from baseline (mmol/L)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arternis Institute for Clinical Research	San Diego	California	United States	92103
2	Clinical Trial Investigators	Tustin	California	United States	92780
3	University of Colorado	Aurora	Colorado	United States	80045
4	Westside Center for Clinical Research	Jacksonville	Florida	United States	32205
5	Pennington Biomedical Research	Baton Rouge	Louisiana	United States	70808
6	Boston University Medical Center	Boston	Massachusetts	United States	02118
7	Cornell Weill Medical College	New York	New York	United States	10065
8	Radiant Research	Cincinnati	Ohio	United States	45249
9	Aventiv Research	Columbus	Ohio	United States	43213
10	Geisinger Health System	Danville	Pennsylvania	United States	17822
11	Texas Diabetes and Endocrinology	Round Rock	Texas	United States	78681
12	Health & Care SRO	Prague		Czechia	182 00
13	University of Cophenhagen	Copenhagen		Denmark	DK-1958
14	IRCCS Policlinico San Donato	Milan		Italy	20097
15	University of Rome	Rome		Italy	00186
16	University of Navarra	Pamplona		Spain	31008

Sponsors and Collaborators

• Gelesis, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gelesis, Inc.
• ClinicalTrials.gov Identifier: NCT03021291
• Other Study ID Numbers: GS-100-009
• First Posted: Jan 13, 2017
• Last Update Posted: Feb 22, 2018
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Feb 22, 2018