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Completed

NCT Number: NCT03021291

Extension Study of Gelesis100 on Body Weight

This study is designed to assess the effect of Gelesis100 on body weight after an additional exposure of 24 weeks in subjects who completed the 24-week treatment period, and had at least 3% weight loss, in the Gelesis Loss Of Weight GLOW, NCT02307279) study.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health & Care SRO, Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Completion of the GLOW study with at least 3% weight loss
  • Informed Consent Form signed by the subjects at the end of the GLOW study

Exclusion criteria

  • Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) 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, or condom and spermicide; bilateral tubal ligation and vasectomy are not acceptable contraceptive methods)
  • Subjects considering smoking cessation during the study
  • Subjects anticipating surgical intervention during the study
  • Significant intolerance to the study product during the GLOW study
  • Increase of ≥ 0.5% point (≥ 5.5 mmol/mol) in HbA1c from the Baseline Visit of the GLOW study in subjects with treated or untreated type 2 diabetes if considered clinically relevant, or any increase if HbA1c is > 8.5% (> 69 mmol/mol)
  • Increase of ≥ 10% in total cholesterol, low-density lipoprotein (LDL) cholesterol, or triglycerides from the Baseline Visit of the GLOW study in subjects with elevated lipids at the Baseline Visit of the GLOW study if considered clinically relevant, or any increase if serum LDL cholesterol is ≥ 190 mg/dL (≥ 4.93 mmol/L) and/or serum triglycerides are ≥ 500 mg/dL (≥ 5.65 mmol/L)
  • Increase of ≥ 10 mm Hg in supine systolic blood pressure (SBP) and/or supine diastolic blood pressure (DBP) from the Baseline Visit of the GLOW study in subjects with treated or untreated hypertension if considered clinically relevant, or any increase if supine SBP is > 160 mm Hg and/or supine DBP is > 95 mm Hg, based on the mean of two consecutive readings
  • Poor subject compliance with the GLOW study procedures and recommendations and/or major protocol deviation
  • Anticipated requirement for use of prohibited concomitant medications

Treatment and study plan

Gelesis100 (2.25 g)

Device

Three capsules of Gelesis100, each containing a 750 mg mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.

Primary outcomes

  1. Change in body weight

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Percent (%) change from baseline

  2. Body weight responders (5%)

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline in body weight of at least 5%

Secondary outcomes

  1. Change in plasma glucose status (normal, impaired, diabetic)

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

  2. Change in plasma glucose

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline in millimoles per liter (mmol/L)

  3. Change in insulin resistance

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR)

  4. Change in glycosylated hemoglobin (HbA1c)

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (%)

  5. Change in body mass index (BMI)

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Measured as body weight in kilograms divided by height in meters-squared (kg/m2)

Other outcomes

  1. Body weight responders (10%)

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline in body weight of at least 10%

  2. Change in excess body weight

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (%)

  3. Change in body weight status (normal, overweight, obese)

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

  4. Change in waist circumference

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline in waist circumference (centimeters)

  5. Change in serum insulin

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline in milliunits per liter (mU/L)

  6. Change in serum C-reactive protein (CRP)

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Measured in milligrams per liter (mg/L)

  7. Change in total cholesterol, serum low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol/HDL ratio, and triglycerides

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    measured in milligrams per deciliter (mg/dL)

  8. Change vital signs: heart rate, supine and standing systolic and diastolic blood pressure (SBP, DBP)

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Measured in beats per minute (heart rate) or millimeters of mercury (mmHg) for blood pressure

  9. Change in food intake

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Assessed by 24 hr dietary recall

  10. Change in Impact of Weight on Quality Of Life (IWQOL)

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change in global and individual questionnaire subscale scores

  11. All adverse events (AE), serious adverse events (SAE), and gastrointestinal symptoms

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Number and % of subjects with AE/SAEs spontaneously reported; gastrointestinal symptoms solicited via questionnaire.

  12. Change in serum sodium

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline in millimoles per liter (mmol/L)

  13. Change in serum potassium

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (mmol/L)

  14. Change in serum chloride

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (mmol/L)

  15. Change in serum calcium

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (mmol/L)

  16. Change in serum magnesium

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (mmol/L)

  17. Change in serum phosphorus

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (mmol/L)

  18. Change in serum glucose

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (mmol/L)

  19. Change in blood urea nitrogen (BUN)

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (mmol/L)

  20. Change in serum creatinine

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline in micromoles per liter (umol/L)

  21. Change in serum uric acid

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (umol/L)

  22. Change in total bilirubin

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (umol/L)

  23. Change in alanine aminotransferase (ALT)

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline in international units per liter (IU/L)

  24. Change in aspartate transaminase (AST)

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (IU/L)

  25. Change in gamma-glutamyl transpeptidase (GGT)

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (IU/L)

  26. Change in alkaline phosphatase (ALP)

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (IU/L)

  27. Change in serum total protein

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (g/L)

  28. Change in serum albumin

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (g/L)

  29. Change in hematocrit

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (%)

  30. Change in hemoglobin

    Time frame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339

    Change from baseline (mmol/L)

Sponsors and collaborators

Lead sponsor

Gelesis, Inc.

Industry

Registry information

Official study title

An Open-label Study Assessing the Effect of Gelesis100 on Weight Loss and Weight Maintenance in Overweight and Obese Subjects Who Completed the GLOW Study (G-04)

Acronym: GLOW-EX

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 13, 2017
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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