OverweightFLOWNCT03008954
Effect of GSP3 on Body Weight in Overweight and Obese Subjects
A study testing GSP3 and Avicel (modified Cellulose) in people with Overweight and Obesity, run by Gelesis, Inc. at 5 sites in 3 countries.
Trial summary
The FLOW (First Loss Of Weight) study is designed to assess the effects of repeated administration of GSP3, an investigational product, on body weight. It is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- GSP3 and Avicel (modified Cellulose)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jul 2012to Feb 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) ≥ 27 and ≤ 35 (at least 30% overweight and 30% obese subjects)
- Ability to follow verbal and written instructions
- Informed Consent Form signed by the subjects
Who cannot join
- Pregnancy or lactation
- 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; bilateral tubal ligation and vasectomy are not acceptable contraceptive methods)
- History of allergic reaction to carboxymethylcellulose, citric acid, modified cellulose, microcrystalline cellulose, and gelatin
- Administration of investigational products within 1 month prior to Screening Visit
- Night-shift workers
- Subjects who stopped smoking within 6 months prior to Screening Visit or considering smoking cessation during the study
Show all 38Show fewer
- Subjects anticipating surgical intervention during the study
- Known type 1 or type 2 diabetes
- History of eating disorders including binge eating (except mild binge eater)
- Weight change > 3 kg within 3 months prior to and during the Screening period
- Supine systolic blood pressure (SBP) > 150 mm Hg and/or supine diastolic blood pressure (DBP) > 90 mm Hg
- Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
- History of gastroesophageal reflux disease
- History of gastric or duodenal ulcer
- History of gastroparesis
- History of gastric bypass or any other gastric surgery
- History of intragastric balloon
- History of pancreatitis
- History of hemorrhoids
- History of malabsorption
- Laxative users
- History of hepatitis B or C
- History of human immunodeficiency virus
- History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
- Any other clinically significant disease interfering with the assessments of Attiva, according to the Investigator
- Positive serum or urine pregnancy test(s) in females of childbearing potential
- Plasma glucose ≥ 126 mg/dL (7.0 mmol/L)
- Abnormal serum thyrotropin (TSH)
- Serum triglycerides > 500 mg/dL (5.65 mmol/L)
- Positive test for drugs in the urine
- Any relevant biochemical abnormality interfering with the assessments of Attiva, according to the Investigator
- Anti-obesity medications (including herbal preparations) within 1 month prior to Screening Visit
- Systemic corticosteroids within 1 month prior to Screening Visit
- Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month)
- Any other medication known to cause weight loss or weight gain within 1 month prior to Screening Visit
- Medications treating hypertension within 1 month prior to Screening Visit
- Medications treating dyslipidemia within 1 month prior to Screening Visit
- Anticipated requirement for use of prohibited concomitant medications
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Italy2 sites
Federico University Hospital
Naples, 80131
Policlinico Umberto I
Rome, 00161
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of GSP3 on Body Weight in Overweight and Obese Subjects
The FLOW (First Loss Of Weight) study is designed to assess the effects of repeated administration of GSP3, an investigational product, on body weight. It is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study. FLOW is being conducted in 5 medical centers in Italy, Czech Republic, and Denmark, and will randomize 123 overweight and obese adult males and females to receive either placebo, GSP3 (2.25g), or GSP3 (3.75g) in addition to a hypocaloric diet (-600 kcal/day) for 12 weeks.
- Conditions
- Overweight, Obesity
- Being tested
- GSP3, Avicel (modified Cellulose)
- Keywords
- weight loss, body composition, glycemic control, satiety
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSP3Device
Each capsule of GSP3 (previously Attiva) contains 700 mg of a mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.
Avicel (modified Cellulose)Dietary supplement
Each capsule of Avicel contains approximately 350 mg of microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Microcyrstalline cellulose (Avicel): provided in 5 capsules (350 mg each), twice daily (BID) prior to lunch and dinner. Receives: Dietary Supplement: Avicel (modified Cellulose) |
| GSP3 (2.25g) | Experimental | GSP3: provided in 3 capsules (750 mg each), plus 2 placebo capsules (350 mg each), twice daily (BID) prior to lunch and dinner Receives: Device: GSP3; Dietary Supplement: Avicel (modified Cellulose) |
| GSP3 (3.75g) | Experimental | GSP3: provided in 5 capsules (750 mg each), twice daily (BID) prior to lunch and dinner Receives: Device: GSP3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Change from baseline in kilograms and percent (%) weight
Measured: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Secondary outcomes (6)
Body weight responders
Change from baseline in body weight of at least 5%
Measured: 12 weeks
Change in waist circumference
Change from baseline in waist circumference (centimeters)
Measured: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Change in fat mass
Change in percentage (%) of total mas from baseline in fat- and bone-free fat mass measured by dual energy X-ray absorptiometry (DEXA)
Measured: Measured at weeks 0 and 13
Change in bone-free fat mass
Change in percentage (%) of total mas from baseline in fat- and bone-free fat mass measured by dual energy X-ray absorptiometry (DEXA)
Measured: Measured at weeks 0 and 13
Change in appetite (hunger, satiety, and fullness)
Assessed by self-administered Visual Analog Scale (VAS)
Measured: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Change in food intake
Assessed by 24 hr dietary recall
Measured: Measured at weeks 0 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startJul 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gelesis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan Heshmati, MD, Study director, Gelesis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008954
- Sponsor's protocol ID
- Attiva-03
- Acronym
- FLOW
- Status last verified
- Feb 2018
- First submitted
- 19 Dec 2016
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Greenway FL, Aronne LJ, Raben A, Astrup A, Apovian CM, Hill JO, Kaplan LM, Fujioka K, Matejkova E, Svacina S, Luzi L, Gnessi L, Navas-Carretero S, Alfredo Martinez J, Still CD, Sannino A, Saponaro C, Demitri C, Urban LE, Leider H, Chiquette E, Ron ES, Zohar Y, Heshmati HM. A Randomized, Double-Blind, Placebo-Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss. Obesity (Silver Spring). 2019 Feb;27(2):205-216. doi: 10.1002/oby.22347. Epub 2018 Nov 13.
PubMed 30421844
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. 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 GSP3 on Body Weight in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT03008954
- Acronym / sponsor ID
- FLOW / Attiva-03
- Conditions
- Overweight, Obesity
- Keywords
- weight loss, body composition, glycemic control, satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Gelesis, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 4 Jan 2017 (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 FLOW (First Loss Of Weight) study is designed to assess the effects of repeated administration of GSP3, an investigational product, on body weight. It is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study. FLOW is being conducted in 5 medical centers in Italy, Czech Republic, and Denmark, and will randomize 123 overweight and obese adult males and females to receive either placebo, GSP3 (2.25g), or GSP3 (3.75g) in addition to a hypocaloric diet (-600 kcal/day) for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Avicel (modified Cellulose)Microcyrstalline cellulose (Avicel): provided in 5 capsules (350 mg each), twice daily (BID) prior to lunch and dinner. |
| GSP3 (2.25g) | Experimental | Device: GSP3, Dietary Supplement: Avicel (modified Cellulose)GSP3: provided in 3 capsules (750 mg each), plus 2 placebo capsules (350 mg each), twice daily (BID) prior to lunch and dinner |
| GSP3 (3.75g) | Experimental | Device: GSP3GSP3: provided in 5 capsules (750 mg each), twice daily (BID) prior to lunch and dinner |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) ≥ 27 and ≤ 35 (at least 30% overweight and 30% obese subjects)
- Ability to follow verbal and written instructions
- Informed Consent Form signed by the subjects
Key exclusion criteria (38 listed)
- Pregnancy or lactation
- 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; bilateral tubal ligation and vasectomy are not acceptable contraceptive methods)
- History of allergic reaction to carboxymethylcellulose, citric acid, modified cellulose, microcrystalline cellulose, and gelatin
- Administration of investigational products within 1 month prior to Screening Visit
- Night-shift workers
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 |
|---|---|---|
| GSP3Each capsule of GSP3 (previously Attiva) contains 700 mg of a mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid. | Device | GSP3 (2.25g), GSP3 (3.75g) |
| Avicel (modified Cellulose)Each capsule of Avicel contains approximately 350 mg of microcrystalline cellulose | Dietary supplement | GSP3 (2.25g), Placebo |
Primary outcome
Change in Body Weight
Time frame: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Change from baseline in kilograms and percent (%) weight
6 secondary outcomes
Body weight responders
Time frame: 12 weeks
Change in waist circumference
Time frame: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Change in fat mass
Time frame: Measured at weeks 0 and 13
Change in bone-free fat mass
Time frame: Measured at weeks 0 and 13
Change in appetite (hunger, satiety, and fullness)
Time frame: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Change in food intake
Time frame: Measured at weeks 0 and 12
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 15 May 2018.
- Derived from this study: PubMed 30421844Greenway FL, Aronne LJ, Raben A, Astrup A, Apovian CM, Hill JO, Kaplan LM, Fujioka K, Matejkova E, Svacina S, Luzi L, Gnessi L, Navas-Carretero S, Alfredo Martinez J, Still CD, Sannino A, Saponaro C, Demitri C, Urban LE, Leider H, Chiquette E, Ron ES, Zohar Y, Heshmati HM. A Randomized, Double-Blind, Placebo-Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss. Obesity (Silver Spring). 2019 Feb;27(2):205-216. doi: 10.1002/oby.22347. Epub 2018 Nov 13.
- 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 Heshmati, MD study director
Gelesis, Inc.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GSP3 and Avicel (modified Cellulose) in people with Overweight and Obesity, run by Gelesis, Inc. at 5 sites in 3 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 3 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 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia, Italy, Denmark. 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?
Change in Body Weight (time frame: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)). 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 NCT03008954, which also lists 1 linked publication.
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 15 May 2018.