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

A study testing Gelesis100 in people with Overweight and Obesity, run by Gelesis, Inc. at 36 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 22 to 65 years
Conditions the study is for: Overweight, Obesity
What is being tested?: Gelesis100
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 436 participants
Where: 36 sitesin 6 countries
Study dates: Nov 2014to Jun 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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)

Who cannot join

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

Show all 24Show fewer

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

Trial locations and contacts

36 sites in 6 countries.

Country

City, postcode or hospital

36 sites in 6 countries

United States25 sites

Investigative Site
Anaheim, California, 92801
Investigative Site
Aurora, Colorado, 80045
Investigative Site
Baton Rouge, Louisiana, 70808
Investigative Site
Boise, Idaho, 83642
Investigative Site
Boston, Massachusetts, 02115
Investigative Site
Chicago, Illinois, 60208
Investigative Site
Cincinnati, Ohio, 45219
Investigative Site
Columbus, Ohio, 43212
Investigative Site
Columbus, Ohio, 43213
Investigative Site
Dallas, Texas, 75246
Investigative Site
Danville, Pennsylvania, 17822
Investigative Site
Jacksonville, Florida, 32205
Investigative Site
Las Vegas, Nevada, 89401
Investigative Site
Miami, Florida, 33143
Investigative Site
Nashville, Tennessee, 37203
Investigative Site
New York, New York, 10065
Investigative Site
Norfolk, Virginia, 23606
Investigative Site
Raleigh, North Carolina, 27612
Investigative Site
Richmond, Virginia, 23294
Investigative Site
Round Rock, Texas, 78681
Investigative Site
San Diego, California, 92103
Investigative Site
Tustin, California, 92780
Investigative Site
Walnut Creek, California, 94598
Investigative Site
West Hills, California, 91307
Investigative Site
West Jordan, Utah, 84088

Other trials in United States

Czechia4 sites

Investigative Site
Hradec, 500 00
Investigative Site
Prague, 121 08
Investigative Site
Prague, 140 00
Investigative Site
Prague, 182 00

Other trials in Czechia

Italy3 sites

Investigative Site
Milan, Milanese, 20097
Investigative Site
Naples, 80131
Investigative Site
Rome, 00161

Other trials in Italy

Canada2 sites

Investigative Site
Ottawa, Ontario, K1N 6N5
Investigative Site
Québec, Quebec, G1V 0A6

Other trials in Canada

Denmark1 site

Investigative Site
Copenhagen, DK-1958

Other trials in Denmark

Spain1 site

Investigative Site
Pamplona, 31008

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Conditions: Overweight, Obesity
Being tested: Gelesis100, placebo
Medical subject headings: Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gelesis100Device
placeboDevice

Study groups in NCT02307279
Study group	Role	What they receive
Gelesis100	Experimental	Gelesis100 twice daily Receives: Device: Gelesis100
Placebo	Placebo comparator	Matching placebo twice daily Receives: Device: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

Percent Body Weight Change in Subjects With Impaired Plasma Glucose Status at Baseline
Impaired plasma glucose status is defined as Fasting Plasma Glucose (FPG) ≥100mg/dL and <126mg/dL at baseline measurement.
Measured: Baseline to Day 171
Change in Plasma Glucose Status (Normal, Impaired, Diabetic) in Subjects With Impaired Plasma Glucose Status at Baseline.
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.
Measured: Baseline to Day 171
Percent Change in Plasma Glucose
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.
Measured: Baseline to Day 171
Change in Body Mass Index (BMI)
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).
Measured: Baseline to Day 171
Change in Hemoglobin HbA1c in Subjects With Type 2 Diabetes at Baseline
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.
Measured: Baseline to Day 171

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Jun 2017

First posted4 Dec 2014 (estimated)
Study startNov 2014
Primary completionJun 2017
Study completionJun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OverweightStudies 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 436 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02307279
Sponsor's protocol ID: G-04
Status last verified: Aug 2022
First submitted: 26 Nov 2014
Last updated: 30 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02307279
Acronym / sponsor ID: G-04
Conditions: Overweight, Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 436 participants (actual)
Lead sponsor: Gelesis, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2014 (actual)
Primary completion: Jun 2017 (actual)
Study completion: Jun 2017 (actual)
First posted: 4 Dec 2014 (estimated)
Results: Posted 30 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Gelesis100	Experimental	Device: Gelesis100Gelesis100 twice daily
Placebo	Placebo comparator	Device: placeboMatching placebo twice daily

Who may qualify

Ages: 22 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (24 listed)

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

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	Device	Gelesis100
placebo	Device	Placebo

Primary outcome

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.
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.

5 secondary outcomes

Percent Body Weight Change in Subjects With Impaired Plasma Glucose Status at Baseline
Time frame: 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
Percent Change in Plasma Glucose
Time frame: Baseline to Day 171
Change in Body Mass Index (BMI)
Time frame: Baseline to Day 171
Change in Hemoglobin HbA1c in Subjects With Type 2 Diabetes at Baseline
Time frame: Baseline to Day 171

Results and safety

Results posted to the registry on 30 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gelesis100	223	172
Placebo	213	152

Primary outcome: Co-Primary Outcome: Percent Change in Body Weight

Time frame: Baseline to Day 171. Mean (Standard Deviation). Unit: percentage change in body weight

Measure	Gelesis100 n = 223	Placebo n = 213
Value	-6.41 (5.79)	-4.39 (5.52)

Gelesis100 vs Placebo: Mean Difference (Net): -2.07 (95% CI -3.24 to -0.90), p = 0.0007, ANCOVA
Gelesis100 vs Placebo: p = 0.1193, ANCOVA

Population analysed: Overall number of patients analyzed is equal to the intention to treat population (all randomized subjects).

Primary outcome: Co-Primary Outcome: Percentage of Subjects Who Achieve Body Weight Loss ≥ 5%

Time frame: Baseline to Day 171. Number. Unit: percentage of participants

Measure	Gelesis100 n = 223	Placebo n = 213
Value	58.6	42.2

Gelesis100: p <0.0001, Binomial Proportion Test
Gelesis100 vs Placebo: Odds Ratio (OR): 2.01 (95% CI 1.34 to 3.01), p = 0.0008, Regression, Logistic

Population analysed: Overall Number of Participants Analyzed is equal to the intention to treat population (all randomized subjects).

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening (Day -21) to Day 197. The adverse device effect (AE) and the serious adverse device effects (SAE) are collected since screening until 28 days after the last administration of the investigational medical device.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gelesis100	0 of 223 (0%)	159 of 223 (71.3%)	0 of 223
Placebo	1 of 211 (0.5%)	149 of 211 (70.6%)	0 of 211

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 M Heshmati, MD study director

Chief Medical Officer

36 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Gelesis100 in people with Overweight and Obesity, run by Gelesis, Inc. at 36 sites in 6 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 4 inclusion and 24 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 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Czechia, Italy, Canada, Denmark and 1 more country. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 30 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Co-Primary Outcome: Percent Change in Body Weight (time frame: Baseline to Day 171). 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?

On the ClinicalTrials.gov record for NCT02307279.

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 30 Aug 2022.