Effect of GSP3 on Body Weight in Overweight and Obese Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of GSP3 on Body Weight in Overweight and Obese Subjects

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Device: GSP3
* Dietary Supplement: Avicel (modified Cellulose)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Microcyrstalline cellulose (Avicel): provided in 5 capsules (350 mg each), twice daily (BID) prior to lunch and dinner. | Dietary Supplement: Avicel (modified Cellulose)<br>* Each capsule of Avicel contains approximately 350 mg of microcrystalline cellulose<br>|
| Experimental: GSP3 (2.25g)<br>GSP3: provided in 3 capsules (750 mg each), plus 2 placebo capsules (350 mg each), twice daily (BID) prior to lunch and dinner | Device: GSP3<br>* 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.<br>Dietary Supplement: Avicel (modified Cellulose)<br>* Each capsule of Avicel contains approximately 350 mg of microcrystalline cellulose<br>|
| Experimental: GSP3 (3.75g)<br>GSP3: provided in 5 capsules (750 mg each), twice daily (BID) prior to lunch and dinner | Device: GSP3<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight responders | Change from baseline in body weight of at least 5% | 12 weeks | 
| Change in waist circumference | 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 | 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 | 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) | 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 | Assessed by 24 hr dietary recall | Measured at weeks 0 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, body composition, glycemic control, satiety