Effects of Gelesis200 on Appetite Parameters, Food Intake, and Glycemic Control in Overweight or Obese Prediabetic Subjects: A Sub-Study of LIGHT-UP

NCT03622424 | Completed

• 1 other identifier: GS-200-003
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effects of Gelesis200 on Appetite Parameters, Food Intake, and Glycemic Control in Overweight or Obese Prediabetic Subjects: A Sub-Study of LIGHT-UP. Some of the patients will receive Gelesis200, the other will receive a combination of Gelesis200 and placebo and the final group will receive just placebo.

Conditions

Overweight and Obesity; PreDiabetes; Type2 Diabetes

Outcome Measures

Primary Outcomes (2)

• The first is placebo-adjusted weight loss of ≥3.0%from baseline to Visit 14 in prediabetic subjects or ≥2.0% in diabetic subjects on Gelesis200.

  Gelesis is observing if subject loose 3% or more of their body weight as a result of their participating in the study.

  26 weeks

• weight loss of >5.0% in at least 35% of prediabetic subjects or in at least 25% of diabetic subjects on Gelesis200.

  Gelesis is observing if pre-diabetic or 25% type 2 diabetic subject loose 5% or more of their body weight as a result of their participating in the study.

  26 weeks

Secondary Outcomes (2)

• statistically significant improvement in HbA1c comparing Gelesis200 to placebo in diabetic subjects

  26 weeks

• improvement in FPG status, post-OGTT plasma glucose status, or post-OGTT plasma glucose AUC in ≥50% of subjects on Gelesis200.

  26 weeks

Other Outcomes (1)

• Number of TEAE for Gelesis200 similar to placebo or clinically acceptable.

  26 weeks

Study Arms (3)

Gelesis200

ACTIVE COMPARATOR

Subjects on this ARM will receive Gelesis200

Device: Gelesis200

Placebo

PLACEBO COMPARATOR

Subjects on this ARM will receive a placebo device

Device: Placebo

Gelesis200 and Placebo

ACTIVE COMPARATOR

Subejcts on this ARM will receive both Gelesis200 and placebo.

Device: Gelesis200 and Placebo

Interventions

Gelesis200 DEVICE

Gelesis200: Three (3)Gelesis200 capsules (2.10 g) three (3) times per day (i.e., breakfast, lunch, and dinner)

Gelesis200

Placebo DEVICE

Placebo: Three (3)placebo capsules three (3) times per day (i.e., breakfast, lunch, and dinner)

Placebo

Gelesis200 and Placebo DEVICE

Placebo and Gelesis200: Three (3) placebo capsules at breakfast,and three (3) Gelesis200 capsules (2.10 g)two (2) times per day (i.e., lunch and dinner)

Gelesis200 and Placebo

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ambulatory subjects
• Age ≥22 years and 65 years
• Body Mass Index (BMI) ≥27 and ≤40 kilogram (kg)/meter (M)2 with body weight \<120 kg
• Prediabetic subjects with FPG ≥100 milligram (mg)/deciliter (dL) and \<126 mg/dL \[≥5.6 millimole (mmol)/liter (L) and \<7.0 mmol/L\] at both Screening Visits with HbA1c ≤6.4% \[≤46 mmol/mole (mol)\] \[if only one (1) value is within this range, the other value should not be ≥126 mg/dL (≥7.0 mmol/L) and HbA1c should be ≥5.7% (≥39 mmol/mol) and ≤6.4% (≤46 mmol/mol)\], untreated diabetic 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 HbA1c ≥6.5% (≥48 mmol/mol) if FPG is \<126 mg/dL (\<7.0 mmol/L) at one (1) or both Screening Visits, or metformin-treated diabetic subjects 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 (\[Symbol\]U)/milliliter (mL) at both Screening Visits in prediabetic subjects
• Ability to follow verbal and written instructions
• Consent obtained via signed ICF

You may not qualify if:

• 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, or titanium dioxide
• Participation in a weight loss study within the past twelve (12) months
• Administration of Gelesis100 or Gelesis200 in a previous study
• Administration of investigational products within one (1) month 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) \>95 mmHg
• 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)

Sponsors & Collaborators

• Gelesis, Inc.: lead
• University of Copenhagen: collaborator

Study Sites (1)

University of Copenhagan

Frederiksberg, DK-1958, Denmark

Location

Related Publications (3)

• Bessesen DH. Update on obesity. J Clin Endocrinol Metab. 2008 Jun;93(6):2027-34. doi: 10.1210/jc.2008-0520.

  PMID: 18539769 BACKGROUND

• NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4.4 million participants. Lancet. 2016 Apr 9;387(10027):1513-1530. doi: 10.1016/S0140-6736(16)00618-8. Epub 2016 Apr 6.

  PMID: 27061677 BACKGROUND

• Pi-Sunyer FX. Medical hazards of obesity. Ann Intern Med. 1993 Oct 1;119(7 Pt 2):655-60. doi: 10.7326/0003-4819-119-7_part_2-199310011-00006.

  PMID: 8363192 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Prediabetic State

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hassan Heshmati, MD

  Gelesis, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Subjects, investigators, and sponsor will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effects of Gelesis200 on Appetite Parameters, Food Intake, and Glycemic Control in Overweight or Obese Prediabetic Subjects: A Sub-Study of LIGHT-UP

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: August 9, 2018
• Study Start: August 22, 2017
• Primary Completion: November 19, 2019
• Study Completion: December 20, 2019
• Last Updated: April 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)