Study of Gelesis100 on Body Weight in Overweight and Obese Subjects With and Without Type 2 Diabetes

August 8, 2022 updated by: Gelesis, Inc.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of Gelesis100 on Body Weight in Overweight and Obese Subjects With and Without Type 2 Diabetes

This study will asses the decrease in body weight after repeated administration of Gelesis100 in overweight and obese subjects with and without Type 2 Diabetes.

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.

Detailed Description

To asses the decrease in body weight after repeated administration of Gelesis100 in overweight and obese subjects with and without Type 2 Diabetes.

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.
436

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

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1N 6N5
        • Investigative Site
    • Quebec
      • Québec, Quebec, Canada, G1V 0A6
        • Investigative Site
  • Czechia
      • Hradec, Czechia, 500 00
        • Investigative Site
      • Prague, Czechia, 121 08
        • Investigative Site
      • Prague, Czechia, 140 00
        • Investigative Site
      • Prague, Czechia, 182 00
        • Investigative Site
  • Denmark
      • Copenhagen, Denmark, DK-1958
        • Investigative Site
  • Italy
      • Naples, Italy, 80131
        • Investigative Site
      • Rome, Italy, 00161
        • Investigative Site
    • Milanese
      • Milan, Milanese, Italy, 20097
        • Investigative Site
  • Spain
      • Pamplona, Spain, 31008
        • Investigative Site
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Investigative Site
      • San Diego, California, United States, 92103
        • Investigative Site
      • Tustin, California, United States, 92780
        • Investigative Site
      • Walnut Creek, California, United States, 94598
        • Investigative Site
      • West Hills, California, United States, 91307
        • Investigative Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Investigative Site
    • Florida
      • Jacksonville, Florida, United States, 32205
        • Investigative Site
      • Miami, Florida, United States, 33143
        • Investigative Site
    • Idaho
      • Boise, Idaho, United States, 83642
        • Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60208
        • Investigative Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Investigative Site
    • Nevada
      • Las Vegas, Nevada, United States, 89401
        • Investigative Site
    • New York
      • New York, New York, United States, 10065
        • Investigative Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Investigative Site
      • Columbus, Ohio, United States, 43212
        • Investigative Site
      • Columbus, Ohio, United States, 43213
        • Investigative Site
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Investigative Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Investigative Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Investigative Site
      • Round Rock, Texas, United States, 78681
        • Investigative Site
    • Utah
      • West Jordan, Utah, United States, 84088
        • Investigative Site
    • Virginia
      • Norfolk, Virginia, United States, 23606
        • Investigative Site
      • Richmond, Virginia, United States, 23294
        • Investigative Site

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:

  • Age 22 to 65 years of age, inclusive
  • Signed Informed Consent Form
  • BMI 27 to 40, inclusive (BMI of <30 should have at least one comorbidity)
  • Fasting plasma glucose 90mg/dL to 145 mg/dL, inclusive; non-diabetic normoglycemic (fasting glucose 90 mg/dL to 100 mg/dL, inclusive); non-diabetic impaired fasting glucose 100mg/dL to 126 mg/dL; and diabetic: untreated (126 mg/dL to 145 mg/dL, inclusive) and metformin-treated (metformin dose 1500mg/DL and less, fasting glucose less than 145 mg/dL, inclusive)

Exclusion Criteria:

  • Pregnancy or lactation
  • Absence of medically approved contraceptive methods in females of childbearing potential
  • History of allergic reaction to modified cellulose, citric acid, sodium stearyl fumarate, raw cane sugar, gelatin, and titanium oxide
  • Administration of investigational products within 1 month prior to Screening Visit
  • Subjects who stopped smoking within 6 months prior to Screening Visit or considering smoking cessation during the study
  • Subjects anticipating surgical intervention during the study
  • Known Type 1 diabetes
  • History of eating disorders
  • Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
  • History of: swallowing disorders, esophogeal anatomic abnormalities, gastroesophageal reflux disease, gastric or duodenal ulcer, gastroparesis (chronic nausea, vomiting, heartburn...), gastric bypass or other gastric surgery, intestinal obstruction or at high risk of including suspected small bowel adhesion, pancreatitis, malabsorption, history of bowel resection (except if related to appendectomy), history of abdominal radiation treatment
  • Laxative users
  • History of: HIV, hepatitis B or C; cancer within the past 5 years
  • Abnormal serum thyroid-stimulating hormone (TSH)
  • Positive urine drug test
  • Anti-obesity medication within 1 month prior to Screening Visit (except stable doses of metformin, no more than 1500 mg/day, for at leaset 1 month in subjects with type 2 diabetes)
  • Systemic corticosteroids within 1 month prior to Screening Visit
  • Thyroid hormones or preparations within 1 month prior to Screening Visit
  • Estrogen within 1 month prior to Screening Visit
  • Any other medication known to cause weight loss or weight gain within 1 month prior to Screening Visit
  • TSH suppression therapy for thyroid cancer
  • medications requiring mandatory administration with meal (lunch or dinner), except metformin
  • Other medication or product used for chronic diseases if their impaired gastrointestinal absorption can cause safety issues
  • Change in medications treating hypertension and/or dyslipidemia within 1 month prior to Screening Visit (including change in dose)
  • Anticipated requirement for use of prohibited concomitant medication

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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 twice daily
Device: Gelesis100
Placebo Comparator: Placebo
Matching placebo twice daily
Device: placebo

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
Co-Primary Outcome: Percent Change in Body Weight
Time Frame: Baseline to Day 171
Percent change in body weight from Baseline to Day 171 is presented.
Baseline to Day 171
Co-Primary Outcome: Percentage of Subjects Who Achieve Body Weight Loss ≥ 5%
Time Frame: Baseline to Day 171
Percentage of participants who achieve a body weight loss ≥ 5% from Baseline to Day 171 is presented.
Baseline to Day 171

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
Percent Body Weight Change in Subjects With Impaired Plasma Glucose Status at Baseline
Time Frame: Baseline to Day 171
Impaired plasma glucose status is defined as Fasting Plasma Glucose (FPG) ≥100mg/dL and <126mg/dL at baseline measurement.
Baseline to Day 171
Change in Plasma Glucose Status (Normal, Impaired, Diabetic) in Subjects With Impaired Plasma Glucose Status at Baseline.
Time Frame: Baseline to Day 171
Normal plasma glucose status is defined FPG ≤ 100mg/dL. Impaired plasma glucose status is defined as FPG ≥100mg/dL and <126mg/dL. Diabetic plasma glucose status was defined as FPG >126mg/dL.
Baseline to Day 171
Percent Change in Plasma Glucose
Time Frame: Baseline to Day 171
Percent change in Plasma Glucose in subjects with impaired glucose and T2D at baseline. Impaired plasma glucose is defined as FPG≥100mg/dL and FPG<126mg/dL.
Baseline to Day 171
Change in Body Mass Index (BMI)
Time Frame: Baseline to Day 171
The BMI was calculated using height (in cm) and weight (in kg) according to the following formula: BMI (kg/m2((superscript 1)) = Weight (kg)/[Height (cm)/100]2(superscript2).
Baseline to Day 171
Change in Hemoglobin HbA1c in Subjects With Type 2 Diabetes at Baseline
Time Frame: Baseline to Day 171
To assess the decrease in HbA1c after repeated administration of Gelesis 100 over a period of 168 days in overweight and obese people with type 2 diabetes, The glycosylated hemoglobin was measured in mmol/mol.
Baseline to Day 171

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
Assess Safety and Tolerability of Administration of Gelesis100
Time Frame: Baseline to Day 197
Adverse Events (AEs), Physical Examinations, Vital Signs, Laboratory Tests
Baseline to Day 197

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 M Heshmati, MD, Chief Medical Officer

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.
November 1, 2014

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.
June 1, 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.
June 1, 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).
November 26, 2014

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.
December 1, 2014

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.
December 4, 2014

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.
August 30, 2022

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.
August 8, 2022

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.
August 1, 2022

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.
  • G-04

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.

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