Obesity Clinical Trial
— LIGHT-UPOfficial title:
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
Verified date | July 2020 |
Source | Gelesis, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 300 |
Est. completion date | January 15, 2021 |
Est. primary completion date | January 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Male or female 2. Age =22 years and =65 years 3. Ambulatory 4. BMI =27 kg/M2 and =40 kg/M2 5. Non-diabetic subjects, including: 1. Normoglycemic subjects with FPG <100 mg/dL [<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 <126 mg/dL (=5.6 mmol/L and =7.0 mmol/L) at both Screening Visits with HbA1c =6.4% (=46 mmol/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)]; 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 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 6. Ability to follow verbal and written instructions 7. Consent obtained via signed ICF Exclusion Criteria: 1. Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) 2. Absence of medically approved contraception in females of childbearing potential (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 a single method above) 3. History of allergic reaction to CMC, citric acid, sodium stearyl fumarate, maltodextrin, gelatin, or titanium dioxide 4. Participation in a weight loss study within the past six (6) months 5. Administration of GSP2, GSP3, Gelesis100, or Gelesis200 in a previous study 6. Administration of investigational products within one (1) month prior to Screening Visit 1 7. Blood transfusion within three (3) months prior to Screening Visit 1 8. Smoking cessation within six (6) months prior to Screening Visit 1 or considering smoking cessation during the study 9. Anticipated surgical intervention during the study period 10. Known Type 1 Diabetes 11. History of eating disorders including binge eating (except mild binge eating) or emesis =2/week from any cause within six (6) months prior to Screening Visit 1 12. Weight change =3% within three (3) months prior to and during the Screening period 13. Supine SBP >160 mm Hg and/or supine DBP >95 mm Hg 14. Angina, coronary bypass, or myocardial infarction within six (6) months prior to Screening Visit 1 15. History of swallowing disorders within six (6) months prior to Screening Visit 1 16. Esophageal anatomic abnormalities (e.g., webs, diverticuli, rings) 17. History of gastric or duodenal ulcer within six (6) months prior to Screening Visit 1 18. History of gastroparesis (e.g., chronic nausea, vomiting =2 occurrences per week, heartburn, etc.) within six (6) months prior to Screening Visit 1 19. History of gastric bypass or any other gastric surgery 20. History of inflammatory bowel diseases 21. History of intestinal stricture (e.g., Crohn's disease) 22. History of intestinal obstruction or high risk of intestinal obstruction, including suspected small bowel adhesions 23. History of pancreatitis within six (6) months prior to Screening Visit 1 24. History of malabsorption within six (6) months prior to Screening Visit 1 25. Laxative users, except those on stable doses within one (1) month prior to Screening Visit 1 26. History of hepatitis B or C within six (6) months prior to Screening Visit 1 27. History of HIV 28. History of cancer within the past five (5) years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer) 29. Any other clinically significant disease interfering with the assessments of Gelesis200 (e.g., disease requiring corrective treatment, potentially leading to study discontinuation) 30. Abnormal serum TSH 31. HbA1c >8.5% (>69 mmol/mol) 32. Serum LDL cholesterol =160 mg/dL (=4.15 mmol/L) 33. Serum triglycerides =350 mg/dL (=3.96 mmol/L) 34. Positive test for drugs of abuse in the urine 35. Any relevant biochemical abnormality interfering with the assessments of Gelesis200 36. Anti-obesity medications (including herbal preparations) within one (1) month prior to Screening Visit 1 37. Systemic corticosteroids within one (1) month prior to Screening Visit 1 38. Thyroid hormones or preparations within one (1) month prior to Screening Visit 1 [except stable dose of replacement therapy for at least two (2) months] 39. TSH suppression therapy for thyroid cancer 40. Estrogen within one (1) month prior to Screening Visit 1 [except stable dose of replacement therapy or contraceptives for at least one (1) month] 41. Any other medication known to cause weight loss or weight gain within one (1) month prior to Screening Visit 1 42. Antidiabetic medications within one (1) month prior to Screening Visit 1 [except stable doses of metformin and DPP-4 inhibitors for at least one (1) month in subjects with Type 2 Diabetes] 43. Change in medications treating hypertension within one (1) month [one (1) week for diuretics] prior to Screening Visit 1 44. Change in medications treating dyslipidemia within one (1) month prior to Screening Visit 1 45. Anticipated requirement for use of prohibited concomitant medications 46. Any other condition that, in the opinion of the Investigator or Sponsor, would interfere with the subject's ability to participate in the study |
Country | Name | City | State |
---|---|---|---|
Canada | University of Ottawa - Institut de Recherche de l'Hospital d'Ottawa (IRHO) (Ottawa Hospital Research Institute (OHRI)) | Ottawa | Ontario |
Canada | Université Laval | Quebec City | Quebec |
Czechia | Health&Care, s.r.o | Prague | |
Denmark | University of Copenhagen - Department of Nutrition, Exercise and Sports | Frederiksberg | |
Hungary | Qualiclinic Kft | Budapest | |
Hungary | Debreceni Egyetem Klinikai Kozpont | Debrecen | |
Hungary | Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz | Gyula | |
Italy | IRCCS Policlinico San Donato | San Donato Milanese | |
Poland | NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny | Bialystok | |
Poland | NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek | Lodz | |
Poland | MEDICOME Sp. z o.o. | Oswiecim | |
Poland | Centrum Zdrowia Metabolicznego Pawel Bogdanski | Poznan | |
Poland | Centrum Badawcze Wspolczesnej Terapii | Warszawa | |
United Kingdom | Oakenhurst Medical Practice | Blackburn | |
United Kingdom | Ashgate Medical Practice (Research Office) | Chesterfield | |
United Kingdom | Aintree University Hospital | Liverpool | |
United Kingdom | The James Cook University Hospital | Middlesbrough | |
United Kingdom | Morriston Hospital | Swansea | |
United States | Central Alabama Research | Birmingham | Alabama |
United States | Meridien Research, Inc - Bradenton | Bradenton | Florida |
United States | Radiant Research | Cincinnati | Ohio |
United States | Mountain View Clinical Research - Greer | Greer | South Carolina |
United States | The Center for Pharmaceutical Research | Kansas City | Kansas |
United States | Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville | Knoxville | Tennessee |
United States | Clinical Research Center of Nevada | Las Vegas | Nevada |
United States | Baptist Diabetes Associates, P.A. | Miami | Florida |
United States | Rainier Clinical Research Center | Renton | Washington |
United States | SAMCRC | San Antonio | Texas |
United States | Tarheel Clinical Research, LLC | Sugar Land | Texas |
United States | Metabolic Research Institute, Inc. | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Gelesis, Inc. |
United States, Canada, Czechia, Denmark, Hungary, Italy, Poland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Proportion of subjects with weight loss =7.5% | In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1) | Change from baseline to day 171 (week 25) | |
Other | Proportion of subjects with weight loss =7.5% | In treated diabetic subjects (subgroup of Cohort 1) | Change from baseline to day 171 (week 25) | |
Other | Proportion of subjects with weight loss =7.5% | Pre-diabetics and untreated diabetics (subgroup of Cohort 1) | Change from baseline to day 171 (week 25) | |
Other | Percent change in body weight | In treated diabetic subjects (subgroup of Cohort 1) | Change from baseline to day 171 (week 25) | |
Other | Percent change in body weight | Pre-diabetics and untreated diabetics (subgroup of Cohort 1) | Change from baseline to day 171 (week 25) | |
Other | Change in waist circumference | In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1) | Change from baseline to day 171 (week 25) | |
Other | Percent change in estimated excess body weight | In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1) | Change from baseline to day 171 (week 25) | |
Other | Change in BMI | In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1) | Change from baseline to day 171 (week 25) | |
Other | Percent change in FSI | In subjects FSI =10 µU/mL in both screening visits (subgroup of Cohort 1) | Change from baseline to day 171 (week 25) | |
Other | Percent change in HOMA-IR and log HOMA-IR | Pre-diabetics and untreated diabetics (subgroup of Cohort 1) | Change from baseline to day 171 (week 25) | |
Other | Percent change in QUICKI | Pre-diabetics and untreated diabetics (subgroup of Cohort 1) | Change from baseline to day 171 (week 25) | |
Other | Percent change in fasting serum lipids | Subjects with dyslipidemia defined as LDL =130 mg/dL (=3.37 mmol/L) and/or triglycerides =150 mg/dL (=1.69 mmol/L)] at baseline (subgroup of Cohort 1) | Change from baseline to day 171 (week 25) | |
Other | Change in blood pressure | Subjects with hypertension defined as SBP =140 mm Hg and/or DBP =90 mm Hg) at baseline (subgroup of Cohort 1) | Change from baseline to day 171 (week 25) | |
Other | Proportion of subjects with weight loss =5.0% | Normoglycemic subjects (Cohort 2) | Change from baseline to day 171 (week 25) | |
Other | Percent change in body weight | Normoglycemic subjects (Cohort 2) | Change from baseline to day 171 (week 25) | |
Other | Percent change in FSI | Subjects with FSI =10 µU/mL at both Screening Visits (subgroup of Cohort 2) | Change from baseline to day 171 (week 25) | |
Other | Percent change in insulin AUC during OGTT | Subjects with FSI =10 µU/mL at both Screening Visits (subgroup of Cohort 2) | Change from baseline to day 171 (week 25) | |
Other | Proportion of subjects with weight loss =7.5% | Normoglycemic subjects (Cohort 2) | Change from baseline to day 171 (week 25) | |
Primary | Proportion of subjects with weight loss =5.0% | In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1) | Change from baseline to day 171 (week 25) | |
Primary | Percent change in body weight | In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1) | Change from baseline to day 171 (week 25) | |
Secondary | Proportion of subjects with weight loss =10.0% | In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1) | Up to 25 weeks | |
Secondary | Proportion of subjects with weight loss =10.0% | Treated diabetics (subgroup of Cohort 1) | Up to 25 weeks | |
Secondary | Proportion of subjects with weight loss =10.0% | Pre-diabetics and untreated diabetics (subgroup of Cohort 1) | Up to 25 weeks | |
Secondary | Proportion of subjects with weight loss =5.0% | Treated diabetic subjects (subgroup of Cohort 1) | Up to 25 weeks | |
Secondary | Proportion of subjects with weight loss =5.0% | Pre-diabetics and untreated diabetics (subgroup of Cohort 1) | Up to 25 weeks | |
Secondary | Percent change in FSI | Pre-diabetics and untreated diabetics (subgroup of Cohort 1) | Up to 25 weeks | |
Secondary | Percent change in insulin AUC during OGTT | Pre-diabetic subjects (subgroup of Cohort 1) | Up to 25 weeks | |
Secondary | Change in HbA1c | Diabetic subjects with HbA1c =7.5% (=58 mmol/mol) at baseline (subgroup of Cohort 1) | Up to 25 weeks |
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