Overweight and ObesityGLOW-EXNCT03021291
Extension Study of Gelesis100 on Body Weight
A study testing Gelesis100 (2.25 g) in people with Overweight and Obesity, run by Gelesis, Inc. at 16 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Gelesis100 (2.25 g)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 25 Jan 2017to 15 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
United States11 sites
University of Colorado
Aurora, Colorado, 80045
Pennington Biomedical Research
Baton Rouge, Louisiana, 70808
Boston University Medical Center
Boston, Massachusetts, 02118
Radiant Research
Cincinnati, Ohio, 45249
Aventiv Research
Columbus, Ohio, 43213
Geisinger Health System
Danville, Pennsylvania, 17822
Westside Center for Clinical Research
Jacksonville, Florida, 32205
Cornell Weill Medical College
New York, New York, 10065
Texas Diabetes and Endocrinology
Round Rock, Texas, 78681
Arternis Institute for Clinical Research
San Diego, California, 92103
Clinical Trial Investigators
Tustin, California, 92780
Italy2 sites
IRCCS Policlinico San Donato
Milan, 20097
University of Rome
Rome, 00186
About this study
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)
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
- Being tested
- Gelesis100 (2.25 g)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Gelesis100 | Experimental | Gelesis100 (2.25 g) twice daily Receives: Device: Gelesis100 (2.25 g) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Percent (%) change from baseline
Measured: 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: 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: 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: 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: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in glycosylated hemoglobin (HbA1c)
Change from baseline (%)
Measured: 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: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start25 Jan 2017
- Primary completion8 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gelesis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan Heshmati, MD, Study director, Gelesis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021291
- Sponsor's protocol ID
- GS-100-009
- Acronym
- GLOW-EX
- Status last verified
- Feb 2018
- First submitted
- 12 Jan 2017
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03021291
- Acronym / sponsor ID
- GLOW-EX / GS-100-009
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gelesis, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gelesis100 | Experimental | Device: Gelesis100 (2.25 g)Gelesis100 (2.25 g) twice daily |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Gelesis100 |
Primary outcome
Change in body weight
Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Percent (%) change from baseline
Body weight responders (5%)
Time frame: 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%
5 secondary outcomes
Change in plasma glucose status (normal, impaired, diabetic)
Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in plasma glucose
Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in insulin resistance
Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in glycosylated hemoglobin (HbA1c)
Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in body mass index (BMI)
Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Heshmati, MD study director
Gelesis, Inc.
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gelesis100 (2.25 g) in people with Overweight and Obesity, run by Gelesis, Inc. at 16 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Italy, Czechia, Denmark, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.