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

February 15, 2018 updated by: Gelesis, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
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%
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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 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
Time Frame: 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)
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 from baseline (%)
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
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body weight responders (10%)
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 10%
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in excess body weight
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
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)
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in waist circumference
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
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
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
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)
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
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
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
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)
Time Frame: 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
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in food intake
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
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)
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
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
Time Frame: 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.
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum sodium
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
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
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change from baseline (mmol/L)
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum chloride
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change from baseline (mmol/L)
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum calcium
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change from baseline (mmol/L)
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum magnesium
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change from baseline (mmol/L)
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum phosphorus
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change from baseline (mmol/L)
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum glucose
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
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)
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change from baseline (mmol/L)
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum creatinine
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
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
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change from baseline (umol/L)
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in total bilirubin
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
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)
Time Frame: 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)
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in aspartate transaminase (AST)
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
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)
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
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)
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
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
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change from baseline (g/L)
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in serum albumin
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change from baseline (g/L)
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in hematocrit
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change from baseline (%)
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change in hemoglobin
Time Frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Change from baseline (mmol/L)
Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gelesis, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hassan Heshmati, MD, Gelesis, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 8, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overweight and Obesity

Clinical Trials on Gelesis100 (2.25 g)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings