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Effect of Gelesis200 on Body Weight in Overweight and Obese Subjects With Prediabetes and With and Without Type 2 Diabetes (LIGHT-UP)

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ClinicalTrials.gov Identifier: NCT03058029
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Gelesis, Inc.

Brief Summary:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of Gelesis200 on Body Weight in Overweight and Obese Subjects without or with Type 2 Diabetes

Condition or disease Intervention/treatment Phase
Overweight and Obesity Device: Gelesis200 Device: Placebo Not Applicable

Detailed Description:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of Gelesis200 on Body Weight in Overweight and Obese Subjects without or with Type 2 Diabetes

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomize, Double-blind, Placebo-controlled, Parallel-group Study Assessing the Effect of Gelesis200 on Body Weight in Overweight and Obese Subjects With Prediabetes and With or Without Type 2 Diabetes
Actual Study Start Date : February 22, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gelesis200
Gelesis200: Three (3) Gelesis200 capsules (2.10 gram (g)) two (2) times per day (id est (i.e.), lunch and dinner
Device: Gelesis200
Subject would take active Glesis200 capsules 3 times per day.

Placebo Comparator: Placebo
Placebo: Three (3) placebo capsules two (2) times per day (i.e., lunch and dinner
Device: Placebo
Subject would take placebo capsules 3 times per day.




Primary Outcome Measures :
  1. Body weight (percent change) [ Time Frame: Up to 31 weeks ]
    Placebo-adjusted weight loss of ≥3.0% from baseline up to 31 weeks in prediabetic subjects or ≥2.0% in diabetic subjects on Gelesis200.

  2. Body weight responders (≥5.0% weight loss) [ Time Frame: Up to 31 weeks ]
    Weight loss of >5.0% in at least 35% of prediabetic subjects or in at least 25% of diabetic subjects on Gelesis200.


Secondary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Up to 31 weeks ]
  2. Percent of subjects with change in HbA1c status (normal, impaired, or diabetic) [ Time Frame: Up to 31 weeks ]
  3. Percent of subjects with change in FPG status (normal, impaired, or diabetic) [ Time Frame: Up to 31 weeks ]
  4. Percent of subjects with change in post-OGTT plasma glucose status (normal, impaired, or diabetic) [ Time Frame: Up to 31 weeks ]
  5. Change or percent change in post-OGTT plasma glucose [ Time Frame: Up to 31 weeks ]
  6. Change or percent change in post-OGTT serum insulin AUC [ Time Frame: Up to 31 weeks ]
  7. Change in FPG [ Time Frame: Up to 31 weeks ]
  8. Change in fasting serum insulin [ Time Frame: Up to 31 weeks ]
  9. Change in HOMA-IR [ Time Frame: Up to 31 weeks ]


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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male or female ambulatory subjects Age ≥22 years and ≤65 years Body Mass Index (BMI) ≥27 and ≤40 kilogram (kg)/meter (M)2

Non-diabetic subjects,including:

  1. Normoglycemic subjects with FPG ≥90 milligram (mg)/deciliter (dL) and <100 mg/dL [≥5.0millimole (mmol)/liter (L) and <5.6 mmol/L] at both Screening Visits with HbA1c <5.7% (<39 mmol/mol), or
  2. Prediabetic subjects with FPG≥100 mg/dL and <126mg/dL [≥5.6 millimole (mmol)/liter (L) and <7.0mmol/L] at both Screening Visits with HbA1c ≤6.4%[≤46 mmol/mole (mol)][if only one (1)value is within this range, the other value should not be ≥126mg/dL (≥7.0mmol/L) and HbA1c should be ≥5.7% (≥39 mmol/mol) and ≤6.4%(≤46 mmol/mol)]

or Diabetic subjects, including:

  1. Untreated subjects with FPG ≤200 mg/dL (≤11.2 mmol/L)at both Screening Visits and either FPG ≥126 mg/dL (≥7.0 mmol/L) at both Screening Visits or FPG <126 mg/dL (<7.0 mmol/L) at one (1) or both Screening Visits with HbA1c ≥6.5% (≥48 mmol/mol), or
  2. Drug-treated subjects with metformin and/or dipeptidyl peptidase-4 (DPP-4)inhibitors with FPG ≥70 mg/dL and ≤270 mg/dL (≥3.9 mmol/L and ≤15.1 mmol/L) at both Screening Visits

Fasting serum insulin <24 microunit (µU)/milliliter (mL)at both Screening Visits in normoglycemic subjects Ability to follow verbal and written instructions Consent obtained via signed ICF

Exclusion Criteria:

Pregnancy [or positive serum or urine pregnancy test(s) in females of childbearing potential] Absence of medically approved contraception in females of childbearing potential[exempli gratia (e.g.), hysterectomy, oral contraceptive medications,intrauterine device combined with a barrier method, two (2) combined barrier methods such as diaphragm and condom or spermicide, or condom and spermicide; bilateral tubal ligation and vasectomy are acceptable contraceptive methods when combined with another single method from above] History of allergic reaction to carboxymethylcellulose(CMC), citric acid, maltodextrin, gelatin, ortitanium dioxide Participation in a weight loss study within the past six (6) months Administration of Prototype 2 (GSP2), Prototype 3 (GSP3), Gelesis100,or Gelesis200 in a previous study Administration of investigational products within one(1) month prior to Screening Visit Blood transfusion within three (3) months prior to Screening Visit Smoking cessation within six(6) months prior to Screening Visit or considering smoking cessation during the study Anticipated surgical intervention during the study period Known Type 1 Diabetes History of eating disorders including binge eating (except for mild binge eating)or emesis ≥2/week from any cause Weight change >3% within three(3) months prior to and during the Screening period Supine systolic blood pressure (SBP) >160 millimeters of mercury (mmHg)and/or supine diastolic blood pressure(DBP) >95mmHg Angina, coronary bypass, or myocardial infarction within six(6)months prior to Screening Visit History of swallowing disorders Esophageal anatomic abnormalities (e.g., webs, diverticuli, rings)•History of gastroesophageal reflux disease History of gastric or duodenal ulcer History of gastroparesis(e.g., chronic nausea, vomiting≥2 occurrences per week, heartburn, etc.) History of gastric bypass or any other gastric surgery History of small bowel resection (except if related to appendectomy) History of intestinal stricture (e.g., Crohn's disease) History of intestinal obstruction or high risk of intestinal obstruction,including suspected small bowel adhesions History of abdominal radiation treatment History of pancreatitis within the past 12 months History of malabsorption Laxative users, except those on stable doses within one (1) month prior to Screening Visit History of hepatitis B or C History of human immunodeficiency virus(HIV) History of cancer within the past five(5) years (except adequately-treated localized basal cell skin cancer or in situuterine cervical cancer) Any other clinically significant disease interfering with the assessments of Gelesis200 (e.g., disease requiring corrective treatment, potentially leading to study discontinuation) Abnormal serum thyroid-stimulating hormone(TSH) HbA1c >8.5% (>69 mmol/mol) Serum low-density lipoprotein (LDL) cholesterol≥160mg/dL (≥4.15mmol/L) Serum triglycerides ≥350 mg/dL (≥3.96mmol/L) Positive test for drugs of abuse in the urine Any relevant biochemical abnormality interfering with the assessments of Gelesis200 Anti-obesity medications (including herbal preparations) within one(1) month prior to Screening Visit Systemic corticosteroids within one (1) month prior to Screening Visit Thyroid hormones or preparations within one (1) month prior to Screening Visit [except stable dose of replacement therapy for at least two(2) months] TSH suppression therapy for thyroid cancer Estrogen within one(1) month prior to Screening Visit [except stable dose of replacement therapy or contraceptives for at least one(1) month] Any other medication known to cause weight loss or weight gain within one (1) month prior to Screening Visit Antidiabetic medications within one (1) month prior to Screening Visit [except stable doses of metformin and DPP-4 inhibitors for at least one (1) month in subjects with Type 2 Diabetes] Change in medications treating hypertension within one (1) month prior to Screening Visit Change in medications treating dyslipidemia within one (1) month prior to Screening Visit Anticipated requirement for use of prohibited concomitant medications Any other condition that,in the opinion of the Investigator or Sponsor, would interfere with the subject's ability to participate in the study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058029


Contacts
Contact: Diana Peremislov, Ph.D 612 234 8500 ext 23719 d.peremislov@medpace.com

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Sponsors and Collaborators
Gelesis, Inc.

Additional Information:
Responsible Party: Gelesis, Inc.
ClinicalTrials.gov Identifier: NCT03058029     History of Changes
Other Study ID Numbers: GS-200-002
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Overweight
Body Weight
Prediabetic State
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases