Healthy Overweight ObeseSTAGENCT02652962
Gelesis200 Safety and Tolerability Study and Effects on Glycemic and Appetite Parameters
A study testing Gelesis200 in people with Healthy Overweight Obese, run by Gelesis, Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to determine the safety and tolerability of Gelesis200. Read more about this study
- Who is it for?
- Ages 22 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Overweight Obese
- What is being tested?
- Gelesis200
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Mar 2016
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male, non-smoker (no use of tobacco products within 6 months prior to screening), ≥ 22 and ≤ 65 years of age, with BMI ≥ 27.0 and < 35.0 kg/m2.
- Healthy as defined by:
- the absence of clinically significant illness and surgery within 12 weeks prior to administration. Subjects vomiting within 24 hours pre-administration will be carefully evaluated for upcoming illness/disease. Inclusion pre-administration is at the discretion of the Qualified Investigator.
- the absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease, including, but not limited to pancreatitis, hepatitis B or C, HIV, swallowing disorders, and gastroesophageal reflux disease (at least 1 episode per week).
- the absence of clinically significant history of gastric or peptic ulcer, small bowel resection (except if related to appendectomy), intestinal stricture (e.g., Crohn's disease), intestinal obstruction or high risk of intestinal obstruction including suspected small bowel adhesions.
- the absence of clinically significant history or known presence of esophageal anatomic abnormalities (e.g., webs, diverticuli, rings), gastroparesis, and malabsorption.
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- the absence of history of gastric bypass, any other gastric surgery and intragastric balloon.
- the absence of history of angina, coronary bypass, and myocardial infarction within 6 months prior to administration.
- the absence of history of abdominal radiation treatment.
- the absence of history of cancer within the past 5 years, except adequately-treated localized basal cell skin cancer.
- Capable of consent.
- Fasting plasma glucose ≥ 90 and <126 mg/dL (equivalent to ≥ 5.0 and < 7.0 mmol/L) at screening.
- Notwithstanding the lower limit of 90 mg/dL (equivalent to 5.0 mmol/L), subjects with higher fasting plasma glucose will be prioritized, and efforts will be made to include subjects with fasting plasma glucose ≥ 100 mg/dL (equivalent to ≥ 5.6 mmol/L) in both cohorts.
Who cannot join
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- Positive urine drug screen at screening.
- History of allergic reactions to carboxymethylcellulose, citric acid, modified cellulose, microcrystalline cellulose, maltodextrin, gelatin, titanium dioxide, or other related substances.
- Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
- Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
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- History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to screening.
- Participation in a clinical trial involving the administration of an investigational or marketed drug or device within 30 days (90 days for biologics) prior to the first administration or concomitant participation in an investigational study involving no drug or device.
- Use of medication other than topical products without significant systemic absorption:
- prescription medication within 30 days prior to the first administration;
- over-the-counter products including natural health products (e.g., food supplements and herbal supplements) within 7 days prior to the first administration, with the exception of the occasional use of acetaminophen (up to 2 g daily);
- a depot injection or an implant of any drug within 3 months prior to the first administration.
- Donation of plasma within 7 days prior to the first administration. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first administration.
- Hemoglobin < 140 g/L and hematocrit < 0.37 L/L at screening.
- Glycosylated hemoglobin (HbA1c ≥ 6.5% which is equivalent to ≥ 48 mmol/mol).
- Serum low-density lipoprotein cholesterol ≥ 190 mg/dL (≥ 4.93 mmol/L).
- Serum triglycerides ≥ 500 mg/dL (≥ 5.65 mmol/L).
- Anticipating surgical intervention during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, 4-Period Study Assessing the Safety, Tolerability and Glycemic and Appetite Effects of Gelesis200 Using Two Different Timings of Administration in Overweight and Obese Subjects
The purpose of this study is to determine the safety and tolerability of Gelesis200.
Read the detailed description
This is a cross-over within parallel design. Parallel groups will receive Gelesis200 either 2 times or 3 times in one day before meals. Within the parallel groups, subjects will cross-over to 4 arms: A) Gelesis200 10 min before meals, B) Gelesis200 30 min before meals, C) Placebo 10 min before meals, D) Placebo 30 min before meals. Postprandial glucose, insulin and subjective appetite ratings will also be measured.
- Conditions
- Healthy Overweight Obese
- Being tested
- Gelesis200, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelesis200Device
3 capsules each containing 0.70 g
PlaceboOther
Also called maltodextrin/microcrystalline cellulose
3 capsules each containing 0.57 g of a mixture of microcrystalline cellulose and maltodextrin in a ratio of approximately 50 ± 10%
| Study group | Role | What they receive |
|---|---|---|
| Gelesis200 x 2, 10 min | Experimental | 3 x 0.70g Gelesis200 capsules administered 10 minutes before each of 2 meals (breakfast, lunch). Receives: Device: Gelesis200 |
| Gelesis200 x 2, 30 min | Experimental | 3 x 0.70g Gelesis200 capsules administered 30 minutes before each of 2 meals (breakfast, lunch). Receives: Device: Gelesis200 |
| Placebo x 2, 10 min | Placebo comparator | 3 x Placebo capsules administered 10 minutes before each of 2 meals (breakfast, lunch). Receives: Other: Placebo |
| Placebo x 2, 30 min | Placebo comparator | 3 x Placebo capsules administered 30 minutes before each of 2 meals (breakfast, lunch). Receives: Other: Placebo |
| Gelesis200 x 3, 10 min | Experimental | 3 x 0.70g Gelesis200 capsules administered 10 minutes before each of 3 meals (breakfast, lunch, dinner). Receives: Device: Gelesis200 |
| Gelesis200 x 3, 30 min | Experimental | 3 x 0.70g Gelesis200 capsules administered 30 minutes before each of 2 meals (breakfast, lunch). Receives: Device: Gelesis200 |
| Placebo x 3, 10 min | Placebo comparator | 3 x Placebo capsules administered 10 minutes before each of 3 meals (breakfast, lunch, dinner). Receives: Other: Placebo |
| Placebo x 3, 30 min | Placebo comparator | 3 x Placebo capsules administered 30 minutes before each of 3 meals (breakfast, lunch, dinner). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/tolerability of Gelesis200 administered two times per day 10 min before meals evaluated through the assessment of AEs, vital signs, clinical laboratory parameters, and physical examination
Treatment-emergent AEs will be tabulated by treatment and cohort. Changes from baseline values in vital signs and clinical laboratory parameters will be evaluated.
Measured: 24 hours post administration
Safety/tolerability of Gelesis200 administered three times per day 10 min before meals evaluated through the assessment of AEs, vital signs, clinical laboratory parameters, and physical examination
Treatment-emergent AEs will be tabulated by treatment and cohort. Changes from baseline values in vital signs and clinical laboratory parameters will be evaluated.
Measured: 24 hours post administration
Safety/tolerability of Gelesis200 administered two times per day 30 min before meals evaluated through the assessment of AEs, vital signs, clinical laboratory parameters, and physical examination
Treatment-emergent AEs will be tabulated by treatment and cohort. Changes from baseline values in vital signs and clinical laboratory parameters will be evaluated.
Measured: 24 hours post administration
Safety/tolerability of Gelesis200 administered three times per day 30 min before meals evaluated through the assessment of AEs, vital signs, clinical laboratory parameters, and physical examination
Treatment-emergent AEs will be tabulated by treatment and cohort. Changes from baseline values in vital signs and clinical laboratory parameters will be evaluated.
Measured: 24 hours post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Overweight ObeseStudies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gelesis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Audet, Principal investigator, Quebec City, Quebec Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652962
- Sponsor's protocol ID
- GS-200-001
- Acronym
- STAGE
- Status last verified
- May 2016
- First submitted
- 18 Dec 2015
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, 4-Period Study Assessing the Safety, Tolerability and Glycemic and Appetite Effects of Gelesis200 Using Two Different Timings of Administration in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT02652962
- Acronym / sponsor ID
- STAGE / GS-200-001
- Conditions
- Healthy Overweight Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gelesis, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Jan 2016 (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.
The purpose of this study is to determine the safety and tolerability of Gelesis200.
Detailed description
This is a cross-over within parallel design. Parallel groups will receive Gelesis200 either 2 times or 3 times in one day before meals. Within the parallel groups, subjects will cross-over to 4 arms: A) Gelesis200 10 min before meals, B) Gelesis200 30 min before meals, C) Placebo 10 min before meals, D) Placebo 30 min before meals. Postprandial glucose, insulin and subjective appetite ratings will also be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Gelesis200 x 2, 10 min | Experimental | Device: Gelesis2003 x 0.70g Gelesis200 capsules administered 10 minutes before each of 2 meals (breakfast, lunch). |
| Gelesis200 x 2, 30 min | Experimental | Device: Gelesis2003 x 0.70g Gelesis200 capsules administered 30 minutes before each of 2 meals (breakfast, lunch). |
| Placebo x 2, 10 min | Placebo comparator | Other: Placebo3 x Placebo capsules administered 10 minutes before each of 2 meals (breakfast, lunch). |
| Placebo x 2, 30 min | Placebo comparator | Other: Placebo3 x Placebo capsules administered 30 minutes before each of 2 meals (breakfast, lunch). |
| Gelesis200 x 3, 10 min | Experimental | Device: Gelesis2003 x 0.70g Gelesis200 capsules administered 10 minutes before each of 3 meals (breakfast, lunch, dinner). |
| Gelesis200 x 3, 30 min | Experimental | Device: Gelesis2003 x 0.70g Gelesis200 capsules administered 30 minutes before each of 2 meals (breakfast, lunch). |
| Placebo x 3, 10 min | Placebo comparator | Other: Placebo3 x Placebo capsules administered 10 minutes before each of 3 meals (breakfast, lunch, dinner). |
| Placebo x 3, 30 min | Placebo comparator | Other: Placebo3 x Placebo capsules administered 30 minutes before each of 3 meals (breakfast, lunch, dinner). |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male, non-smoker (no use of tobacco products within 6 months prior to screening), ≥ 22 and ≤ 65 years of age, with BMI ≥ 27.0 and < 35.0 kg/m2.
- Healthy as defined by:
- Capable of consent.
- Fasting plasma glucose ≥ 90 and <126 mg/dL (equivalent to ≥ 5.0 and < 7.0 mmol/L) at screening.
- Notwithstanding the lower limit of 90 mg/dL (equivalent to 5.0 mmol/L), subjects with higher fasting plasma glucose will be prioritized, and efforts will be made to include subjects with fasting plasma glucose ≥ 100 mg/dL (equivalent to ≥ 5.6 mmol/L) in both cohorts.
Key exclusion criteria (18 listed)
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- Positive urine drug screen at screening.
- History of allergic reactions to carboxymethylcellulose, citric acid, modified cellulose, microcrystalline cellulose, maltodextrin, gelatin, titanium dioxide, or other related substances.
- Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
- Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
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 |
|---|---|---|
| Gelesis2003 capsules each containing 0.70 g | Device | Gelesis200 x 2, 10 min, Gelesis200 x 2, 30 min, Gelesis200 x 3, 10 min, Gelesis200 x 3, 30 min |
| PlaceboAlso: maltodextrin/microcrystalline cellulose3 capsules each containing 0.57 g of a mixture of microcrystalline cellulose and maltodextrin in a ratio of approximately 50 ± 10% | Other | Placebo x 2, 10 min, Placebo x 2, 30 min, Placebo x 3, 10 min, Placebo x 3, 30 min |
Primary outcome
Safety/tolerability of Gelesis200 administered two times per day 10 min before meals evaluated through the assessment of AEs, vital signs, clinical laboratory parameters, and physical examination
Time frame: 24 hours post administration
Treatment-emergent AEs will be tabulated by treatment and cohort. Changes from baseline values in vital signs and clinical laboratory parameters will be evaluated.
Safety/tolerability of Gelesis200 administered three times per day 10 min before meals evaluated through the assessment of AEs, vital signs, clinical laboratory parameters, and physical examination
Time frame: 24 hours post administration
Treatment-emergent AEs will be tabulated by treatment and cohort. Changes from baseline values in vital signs and clinical laboratory parameters will be evaluated.
Safety/tolerability of Gelesis200 administered two times per day 30 min before meals evaluated through the assessment of AEs, vital signs, clinical laboratory parameters, and physical examination
Time frame: 24 hours post administration
Treatment-emergent AEs will be tabulated by treatment and cohort. Changes from baseline values in vital signs and clinical laboratory parameters will be evaluated.
Safety/tolerability of Gelesis200 administered three times per day 30 min before meals evaluated through the assessment of AEs, vital signs, clinical laboratory parameters, and physical examination
Time frame: 24 hours post administration
Treatment-emergent AEs will be tabulated by treatment and cohort. Changes from baseline values in vital signs and clinical laboratory parameters will be evaluated.
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 9 May 2016.
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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.
Audet principal investigator
Quebec City, Quebec Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gelesis200 in people with Healthy Overweight Obese, run by Gelesis, Inc. at 1 site in Canada.
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 13 inclusion and 18 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 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
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?
Safety/tolerability of Gelesis200 administered two times per day 10 min before meals evaluated through the assessment of AEs, vital signs, clinical laboratory parameters, and physical examination (time frame: 24 hours post administration). The study lists 4 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 9 May 2016.