OverweightNCT02487602
A Scintigraphic Study to Investigate the Effect of Gelesis100 on Gastric Emptying in Overweight and Obese Subjects
A study testing Gelesis100 in people with Overweight and Obesity, run by Gelesis, Inc. at 1 site in United Kingdom.
Trial summary
The purpose of the study is to evaluate the gastrointestinal behaviour of a novel weight loss device in vivo to further understand the device's mechanism of action in aiding weight loss. 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
- Overweight, Obesity
- What is being tested?
- Gelesis100
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Jul 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
- Weight \& Body mass index (BMI)
- BMI between 27 and 35 kg/m², inclusive.
- Body weight ≥50 kg
- Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent (signed and dated) obtained before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject.
- General health: Good general health with (in the opinion of the Investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
Who cannot join
- Medical History
- Current or recurrent disease that, in the opinion of the physician responsible, could affect the study conduct or laboratory assessments (e.g., hepatic disorders, renal insufficiency, congestive heart failure).
- Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
- A history of current or relevant previous non self-limiting GI disorders.
- A history of gastric bypass or any other gastric surgery.
- Acute diarrhoea or constipation in the 14 days before the assessment visit. Diarrhoea will be defined as the passage of liquid faeces and/or stool frequency greater than 3 times per day. Constipation will be defined as failure to open bowels at least every other day.
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- Currently suffering from disease known to impact gastric emptying, e.g., migraine, type 1 and type 2 diabetes.
- As a result of a physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study.
- Medications
- Subject has taken prescribed medication within 14 days prior to the first assessment visit. Subjects will be withdrawn from subsequent study days if they commence taking prescribed medication during the study period.
- Subject has taken over-the-counter (OTC) medication within 48 hr prior to the assessment visits. This includes the use of vitamins and natural or herbal remedies e.g., St John's Wort.
- Subject has taken OTC and/or prescribed Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) daily or regularly within 3 months prior to the first assessment visit. Subjects will be withdrawn from subsequent study days if they commence taking OTC and/or prescribed NSAIDS during the study period.
- Alcohol/Substance Abuse
- Recent history (within the last year) of alcohol or other substance abuse.
- Subject has an average weekly alcohol intake of greater than 21 units. 1 unit is equivalent to one 25 mL single measure of whisky, or a third of a pint of beer or half a standard (175 mL) glass of red wine.
- Subject has positive urine drugs of abuse test at screening.
- Subject has a positive breath alcohol test at screening.
- Smoking
- Subject has recently discontinued smoking (less than 6 months).
- Subject is currently a smoker or user of nicotine-containing products.
- Allergy/Intolerance
- Subject has a history of allergy to a drug, to any component of the dosage form or any other allergy, which, in the opinion of the physician responsible, contraindicates their participation.
- Has an allergy to any of the contents of the standardized breakfast or lunch.
- Subject is vegetarian.
- Subject is lactose intolerant.
- Clinical Studies
- Participation in another clinical study (inclusive of final post-study examination) or receipt of an investigational drug within the 12 weeks before first screening visit.
- Previous participation in this study.
- Subject whose participation in this study will result in a participation in more than four studies over a 12-month period.
- Personnel
- An employee of the sponsor, client or study site or members of their immediate family.
- Radiation Exposure
- Subjects for whom participation in this study will exceed the limits of total radiation exposure allowed in any 12-month period (5 mSv), or will exceed 10 mSv over any three-year period.
- Subjects who are intending to father a child in the 3 months following the study or are unwilling to abstain from sexual intercourse with pregnant or lactating women.
- Subjects who are unwilling to use a condom/spermicide in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the assessment visit until 3 months following the study.
- Blood
- Subject has donated blood or experienced significant blood loss within 3 months of screening and for the duration of the study.
- Other a. Subject has any non-removable metal objects such as metal plates, screws etc in their chest or abdominal area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Partially-blinded, Cross-over Scintigraphic Study to Investigate the Effect of Gelesis100 on Gastric Emptying in Overweight and Obese Subjects
The purpose of the study is to evaluate the gastrointestinal behaviour of a novel weight loss device in vivo to further understand the device's mechanism of action in aiding weight loss.
Read the detailed description
Gelesis100 is a new, experimental medical device which has been developed by Gelesis, Inc. to aid weight loss in overweight/obese patients by reducing the amount of food required to make them feel full. The device is contained in a capsule which is swallowed with water before a meal. Once swallowed, the capsule dissolves and the capsule contents hydrate and mix with the food in the stomach, creating a feeling of fullness.
Four different treatments of up to 5 capsules each will be given to participants during this study. These will be a mixture of the Gelesis100 capsules and capsules which do not contain the device i.e., they are placebo (will contain sucrose [sugar])
The study is designed to look at:
- The time it takes for the stomach to empty once receiving each treatment
- The time it takes for food and Gelesis100 to travel through the intestine
- The effects of Gelesis100 on the feeling of satiety (how full participants feel)
In order to monitor gastrointestinal behavior, either a small amount of radioactive material will be added to a component of a standard lunch or to the water given with the treatment. The radiation emitted will then be detected as it travels through the GI tract by taking images using a device known as a gamma camera. The procedure is relatively easy and non- invasive.
- 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
Gelesis100 capsules
PlaceboOther
Sucrose (sugar) capsules
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Up to 5 Gelesis100 and/or placebo capsules 30 minutes before a standard radiolabeled lunch. Receives: Device: Gelesis100; Other: Placebo |
| B | Active comparator | Up to 5 Gelesis100 and/or placebo capsules 30 minutes before a standard radiolabeled lunch. Receives: Device: Gelesis100; Other: Placebo |
| C | Placebo comparator | Placebo capsules 30 minutes before a standard radiolabeled lunch. Receives: Other: Placebo |
| D | Experimental | Up to 5 Gelesis100 and/or placebo capsules 30 minutes before a radiolabeled water. Receives: Device: Gelesis100; Other: Placebo |
| E | Experimental | Up to 5 Gelesis100 and/or placebo capsules 10 minutes before a radiolabeled meal. Receives: Device: Gelesis100; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying kinetics of a radiolabelled meal following administration of two different doses of Gelesis100 and placebo and two different meals
Scintigraphic images of the radiation emitted by the meal will be obtained using a gamma camera. Time to 50% and 90% emptying will be assessed in addition to amount of radiation remaining in the stomach over time.
Measured: up to 10 hours on each of 3 Assessment Visit days
GI transit time of a radiolabelled meal following administration of two different doses of Gelesis 100 and placebo and two different meals
Scintigraphic images of the radiation emitted by the meal will be obtained using a gamma camera. Time to arrival of radiation at the colon will be assessed.
Measured: up to 10 hours on each of 3 Assessment Visit Days
Secondary outcomes (6)
Water uptake behavior of Gelesis100
Scintigraphic images of the radiation emitted by the water will be obtained using a gamma camera. Descriptions and times related to how the radiolabelled water is taken up by Gelesis100 will be assessed.
Measured: up to 10 hours on one Assesssment Visit day
Gastric emptying of Gelesis100
Scintigraphic images of the radiation emitted by the water will be obtained using a gamma camera. Descriptions and times related to how the radiolabelled water empties from the stomach will be assessed.
Measured: up to 10 hours on one Assesssment Visit day
Gastric emptying of a radiolabeled high fat meal when Gelesis100 is taken 10 minutes before the meal
Scintigraphic images of the radiation emitted by a high fat meal will be obtained using a gamma camera. Descriptions and times related to how the radiolabelled meal empties from the stomach will be assessed.
Measured: up to 10 hours on one Assesssment Visit day
GI transit times of Gelesis100
Scintigraphic images of the radiation emitted by the water will be obtained using a gamma camera. Time to arrival of radiation at the colon will be assessed.
Measured: up to 10 hours on one Assesssment Visit day
GI transit times of a high fat radiolabeled meal when Gelesis100 is taken 10 minutes before the meal
Scintigraphic images of the radiation emitted by a high fat meal will be obtained using a gamma camera. Time to arrival of radiation at the colon will be assessed.
Measured: up to 10 hours on one Assesssment Visit day
The effects of Gelesis100 on feelings of satiety
A questionnaire will be administered several times during 2 hours on each Assessment Visit day. Area under the curve and maximum, and minimum values for the questions will be assessed.
Measured: 2 hours on each of 4 Assessment Visit days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gelesis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BDD Pharma Ltd
- Responsible party
- Sponsor
- Investigators
- Hassan M Heshmati, M.D., Study director, Gelesis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487602
- Sponsor's protocol ID
- GS-100-006
- Status last verified
- Aug 2016
- First submitted
- 26 Jun 2015
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Partially-blinded, Cross-over Scintigraphic Study to Investigate the Effect of Gelesis100 on Gastric Emptying in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT02487602
- Acronym / sponsor ID
- GS-100-006
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Gelesis, Inc.Industry (pharma, biotech, devices)
- Collaborators
- BDD Pharma Ltd
- Study start
- Sep 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Jul 2015 (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 the study is to evaluate the gastrointestinal behaviour of a novel weight loss device in vivo to further understand the device's mechanism of action in aiding weight loss.
Detailed description
Gelesis100 is a new, experimental medical device which has been developed by Gelesis, Inc. to aid weight loss in overweight/obese patients by reducing the amount of food required to make them feel full. The device is contained in a capsule which is swallowed with water before a meal. Once swallowed, the capsule dissolves and the capsule contents hydrate and mix with the food in the stomach, creating a feeling of fullness.
Four different treatments of up to 5 capsules each will be given to participants during this study. These will be a mixture of the Gelesis100 capsules and capsules which do not contain the device i.e., they are placebo (will contain sucrose [sugar])
The study is designed to look at:
- The time it takes for the stomach to empty once receiving each treatment
- The time it takes for food and Gelesis100 to travel through the intestine
- The effects of Gelesis100 on the feeling of satiety (how full participants feel)
In order to monitor gastrointestinal behavior, either a small amount of radioactive material will be added to a component of a standard lunch or to the water given with the treatment. The radiation emitted will then be detected as it travels through the GI tract by taking images using a device known as a gamma camera. The procedure is relatively easy and non- invasive.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: Gelesis100, Other: PlaceboUp to 5 Gelesis100 and/or placebo capsules 30 minutes before a standard radiolabeled lunch. |
| B | Active comparator | Device: Gelesis100, Other: PlaceboUp to 5 Gelesis100 and/or placebo capsules 30 minutes before a standard radiolabeled lunch. |
| C | Placebo comparator | Other: PlaceboPlacebo capsules 30 minutes before a standard radiolabeled lunch. |
| D | Experimental | Device: Gelesis100, Other: PlaceboUp to 5 Gelesis100 and/or placebo capsules 30 minutes before a radiolabeled water. |
| E | Experimental | Device: Gelesis100, Other: PlaceboUp to 5 Gelesis100 and/or placebo capsules 10 minutes before a radiolabeled meal. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Weight \& Body mass index (BMI)
- Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent (signed and dated) obtained before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject.
- General health: Good general health with (in the opinion of the Investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
Key exclusion criteria (38 listed)
- Medical History
- Medications
- Alcohol/Substance Abuse
- Smoking
- Allergy/Intolerance
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 |
|---|---|---|
| Gelesis100Gelesis100 capsules | Device | A, B, D, E |
| PlaceboSucrose (sugar) capsules | Other | A, B, C, D, E |
Primary outcome
Gastric emptying kinetics of a radiolabelled meal following administration of two different doses of Gelesis100 and placebo and two different meals
Time frame: up to 10 hours on each of 3 Assessment Visit days
Scintigraphic images of the radiation emitted by the meal will be obtained using a gamma camera. Time to 50% and 90% emptying will be assessed in addition to amount of radiation remaining in the stomach over time.
GI transit time of a radiolabelled meal following administration of two different doses of Gelesis 100 and placebo and two different meals
Time frame: up to 10 hours on each of 3 Assessment Visit Days
Scintigraphic images of the radiation emitted by the meal will be obtained using a gamma camera. Time to arrival of radiation at the colon will be assessed.
6 secondary outcomes
Water uptake behavior of Gelesis100
Time frame: up to 10 hours on one Assesssment Visit day
Gastric emptying of Gelesis100
Time frame: up to 10 hours on one Assesssment Visit day
Gastric emptying of a radiolabeled high fat meal when Gelesis100 is taken 10 minutes before the meal
Time frame: up to 10 hours on one Assesssment Visit day
GI transit times of Gelesis100
Time frame: up to 10 hours on one Assesssment Visit day
GI transit times of a high fat radiolabeled meal when Gelesis100 is taken 10 minutes before the meal
Time frame: up to 10 hours on one Assesssment Visit day
The effects of Gelesis100 on feelings of satiety
Time frame: 2 hours on each of 4 Assessment Visit days
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 23 Aug 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.
Hassan M Heshmati, M.D. study director
Gelesis, Inc.
1 site in 1 country: 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 1 site in United Kingdom.
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 6 inclusion and 38 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 23 Aug 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 United Kingdom. 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?
Gastric emptying kinetics of a radiolabelled meal following administration of two different doses of Gelesis100 and placebo and two different meals (time frame: up to 10 hours on each of 3 Assessment Visit days). 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 23 Aug 2016.