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

G

Gelesis

Status

Completed

Conditions

Overweight
Obesity

Treatments

Device: GSP3
Dietary Supplement: Avicel (modified Cellulose)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03008954
Attiva-03

Details and patient eligibility

About

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.

Enrollment

128 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

128 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Microcyrstalline cellulose (Avicel): provided in 5 capsules (350 mg each), twice daily (BID) prior to lunch and dinner.
Treatment:
Dietary Supplement: Avicel (modified Cellulose)
GSP3 (2.25g)
Experimental group
Description:
GSP3: provided in 3 capsules (750 mg each), plus 2 placebo capsules (350 mg each), twice daily (BID) prior to lunch and dinner
Treatment:
Device: GSP3
Dietary Supplement: Avicel (modified Cellulose)
GSP3 (3.75g)
Experimental group
Description:
GSP3: provided in 5 capsules (750 mg each), twice daily (BID) prior to lunch and dinner
Treatment:
Device: GSP3

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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