NCT03008954

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
Last Updated

May 15, 2018

Status Verified

February 1, 2018

Enrollment Period

7 months

First QC Date

December 19, 2016

Last Update Submit

May 9, 2018

Conditions

OverweightObesity

Keywords

weight lossbody compositionglycemic controlsatiety

Outcome Measures

Primary Outcomes (1)

  • Change in Body Weight

    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 Outcomes (6)

  • Body weight responders

    12 weeks

  • Change in waist circumference

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

  • Change in fat mass

    Measured at weeks 0 and 13

  • Change in bone-free fat mass

    Measured at weeks 0 and 13

  • Change in appetite (hunger, satiety, and fullness)

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

  • +1 more secondary outcomes

Other Outcomes (27)

  • Change in plasma glucose

    Measured at baseline and week 13

  • Change in plasma glucose status (normal, impaired, diabetic)

    Measured at weeks 0 and 13

  • Change in serum insulin

    Measured at weeks 0 and 13

  • +24 more other outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Microcyrstalline cellulose (Avicel): provided in 5 capsules (350 mg each), twice daily (BID) prior to lunch and dinner.

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

Device: GSP3Dietary Supplement: Avicel (modified Cellulose)

GSP3 (3.75g)

EXPERIMENTAL

GSP3: provided in 5 capsules (750 mg each), twice daily (BID) prior to lunch and dinner

Device: GSP3

Interventions

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.

GSP3 (2.25g)GSP3 (3.75g)
Avicel (modified Cellulose)DIETARY_SUPPLEMENT

Each capsule of Avicel contains approximately 350 mg of microcrystalline cellulose

GSP3 (2.25g)Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hradec Králové

Hradec, 500 00, Czechia

Location

Charles University

Prague, 121 08, Czechia

Location

University of Cophenhagen

Copenhagen, DK-1958, Denmark

Location

Federico University Hospital

Naples, 80131, Italy

Location

Policlinico Umberto I

Rome, 00161, Italy

Location

Related Publications (1)

  • 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.

    PMID: 30421844DERIVED

MeSH Terms

Conditions

OverweightObesityWeight Loss

Interventions

Cellulosehydroxypropylcellulose

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Hassan Heshmati, MD

    Gelesis, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2016

First Posted

January 4, 2017

Study Start

July 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

May 15, 2018

Record last verified: 2018-02

Locations

CZ(2)DK(1)IT(2)