Effect of GSP3 on Body Weight in Overweight and Obese Subjects (FLOW)

May 9, 2018 updated by: Gelesis, Inc.

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.

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.

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.
128

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

  • Czechia
      • Hradec, Czechia, 500 00
        • Hradec Kralove
      • Prague, Czechia, 121 08
        • Charles University
  • Denmark
      • Copenhagen, Denmark, DK-1958
        • University of Cophenhagen
  • Italy
      • Naples, Italy, 80131
        • Federico University Hospital
      • Rome, Italy, 00161
        • Policlinico Umberto I

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Body Mass Index (BMI) ≥ 27 and ≤ 35 (at least 30% overweight and 30% obese subjects)
  2. Ability to follow verbal and written instructions
  3. Informed Consent Form signed by the subjects

Exclusion Criteria:

  1. Pregnancy or lactation
  2. 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)
  3. History of allergic reaction to carboxymethylcellulose, citric acid, modified cellulose, microcrystalline cellulose, and gelatin
  4. Administration of investigational products within 1 month prior to Screening Visit
  5. Night-shift workers
  6. Subjects who stopped smoking within 6 months prior to Screening Visit or considering smoking cessation during the study
  7. Subjects anticipating surgical intervention during the study
  8. Known type 1 or type 2 diabetes
  9. History of eating disorders including binge eating (except mild binge eater)
  10. Weight change > 3 kg within 3 months prior to and during the Screening period
  11. Supine systolic blood pressure (SBP) > 150 mm Hg and/or supine diastolic blood pressure (DBP) > 90 mm Hg
  12. Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
  13. History of gastroesophageal reflux disease
  14. History of gastric or duodenal ulcer
  15. History of gastroparesis
  16. History of gastric bypass or any other gastric surgery
  17. History of intragastric balloon
  18. History of pancreatitis
  19. History of hemorrhoids
  20. History of malabsorption
  21. Laxative users
  22. History of hepatitis B or C
  23. History of human immunodeficiency virus
  24. History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
  25. Any other clinically significant disease interfering with the assessments of Attiva, according to the Investigator
  26. Positive serum or urine pregnancy test(s) in females of childbearing potential
  27. Plasma glucose ≥ 126 mg/dL (7.0 mmol/L)
  28. Abnormal serum thyrotropin (TSH)
  29. Serum triglycerides > 500 mg/dL (5.65 mmol/L)
  30. Positive test for drugs in the urine
  31. Any relevant biochemical abnormality interfering with the assessments of Attiva, according to the Investigator
  32. Anti-obesity medications (including herbal preparations) within 1 month prior to Screening Visit
  33. Systemic corticosteroids within 1 month prior to Screening Visit
  34. 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)
  35. Any other medication known to cause weight loss or weight gain within 1 month prior to Screening Visit
  36. Medications treating hypertension within 1 month prior to Screening Visit
  37. Medications treating dyslipidemia within 1 month prior to Screening Visit
  38. Anticipated requirement for use of prohibited concomitant medications

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: Double

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.
Placebo Comparator: Placebo
Microcyrstalline cellulose (Avicel): provided in 5 capsules (350 mg each), twice daily (BID) prior to lunch and dinner.
Dietary supplement: Avicel (modified Cellulose)
Each capsule of Avicel contains approximately 350 mg of microcrystalline cellulose
Experimental: GSP3 (2.25g)
GSP3: provided in 3 capsules (750 mg each), plus 2 placebo capsules (350 mg each), twice daily (BID) prior to lunch and dinner
Dietary supplement: Avicel (modified Cellulose)
Each capsule of Avicel contains approximately 350 mg of microcrystalline cellulose
Device: GSP3
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.
Experimental: GSP3 (3.75g)
GSP3: provided in 5 capsules (750 mg each), twice daily (BID) prior to lunch and dinner
Device: GSP3
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.

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
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
Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)

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
Body weight responders
Time Frame: 12 weeks
Change from baseline in body weight of at least 5%
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 from baseline in waist circumference (centimeters)
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 percentage (%) of total mas from baseline in fat- and bone-free fat mass measured by dual energy X-ray absorptiometry (DEXA)
Measured at weeks 0 and 13
Change in bone-free fat mass
Time Frame: Measured at weeks 0 and 13
Change in percentage (%) of total mas from baseline in fat- and bone-free fat mass measured by dual energy X-ray absorptiometry (DEXA)
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)
Assessed by self-administered Visual Analog Scale (VAS)
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
Assessed by 24 hr dietary recall
Measured at weeks 0 and 12

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
Change in plasma glucose
Time Frame: Measured at baseline and week 13
Change from baseline in millimoles per liter (mmol/L)
Measured at baseline and week 13
Change in plasma glucose status (normal, impaired, diabetic)
Time Frame: Measured at weeks 0 and 13
Measured at weeks 0 and 13
Change in serum insulin
Time Frame: Measured at weeks 0 and 13
Change from baseline in miliunits per liter (mU/L)
Measured at weeks 0 and 13
Change in insulin resistance
Time Frame: Measured at weeks 0 and 13
Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR)
Measured at weeks 0 and 13
Change in glycosylated hemoglobin (HbA1c)
Time Frame: Measured at weeks 0 and 13
Measured in percentage (%)
Measured at weeks 0 and 13
Change in total cholesterol, serum low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol/HDL ratio, and triglycerides
Time Frame: Measured at weeks 0 and 13
measured in mg/dL
Measured at weeks 0 and 13
Change vital signs: heart rate, supine and standing systolic and diastolic blood pressure (SBP, DBP)
Time Frame: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Measured in beats per minute (heart rate) or millimeters of mercury (mmHg) for blood pressure
Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
All adverse events (AE), serious adverse events (SAE), and gastrointestinal symptoms
Time Frame: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Number and % of subjects with AE/SAEs spontaneously reported; gastrointestinal symptoms solicited via questionnaire
Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Change in serum sodium
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline in millimoles per liter (mmol/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in serum potassium
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline (mmol/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in serum coloride
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline (mmol/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in serum calcium
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline (mmol/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in serum magnesium
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline (mmol/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in serum phosphorus
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline (mmol/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in serum glucose
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline (mmol/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in blood urea nitrogen (BUN)
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline (mmol/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in serum creatinine
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline in micromoles per liter (umol/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in serum uric acid
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline (umol/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in total bilirubin
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline (umol/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in alanine aminotransferase (ALT)
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline in international units per liter (IU/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in aspartate transaminase (AST)
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline (IU/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in gamma-glutamyl transpeptidase (GGT)
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline (IU/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in alkaline phosphatase (ALP)
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline (IU/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in serum total protein
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline in grams per liter (g/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in serum albumin
Time Frame: Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change from baseline (g/L)
Measured at weeks 0,4,8,12,13 and follow up (week 14)
Change in hematocrit
Time Frame: Measured at weeks 0,4,8,12,13 and follow-up (week 14)
Change from baseline (%)
Measured at weeks 0,4,8,12,13 and follow-up (week 14)
Change in hemoglobin
Time Frame: Measured at weeks 0,4,8,12,13 and follow-up (week 14)
Change from baseline (%)
Measured at weeks 0,4,8,12,13 and follow-up (week 14)

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 Heshmati, MD, Gelesis, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
July 1, 2012

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.
February 1, 2013

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.
February 1, 2013

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).
December 19, 2016

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 30, 2016

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.
January 4, 2017

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.
May 15, 2018

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.
May 9, 2018

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.
February 1, 2018

More Information

Terms related to this study

Keywords

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.
  • Attiva-03

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

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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Drug Interventions

Conditions

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Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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