OverweightLIGHT-UPNCT03058029
Effect of Gelesis200 on Body Weight in Overweight and Obese Subjects w/o Type 2 Diabetes
A study testing Gelesis200 in people with Overweight and Diabetes, run by Gelesis, Inc. at 30 sites in 8 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Overweight, Diabetes, PreDiabetes
- What is being tested?
- Gelesis200
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 30 sitesin 8 countries
- Study dates
- 22 Feb 2017to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Age ≥22 years and ≤65 years
- Ambulatory
- BMI ≥27 kg/M2 and ≤40 kg/M2
- Non-diabetic subjects, including:
- Normoglycemic subjects with FPG <100 mg/dL [<5.6 mmol/L] at both Screening Visits with HbA1c <5.7% (<39 mmol/mol), or
Show all 12Show fewer
- 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:
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- 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
- 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
- Ability to follow verbal and written instructions
- Consent obtained via signed ICF
Who cannot join
- Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential)
- 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)
- History of allergic reaction to CMC, citric acid, sodium stearyl fumarate, maltodextrin, gelatin, or titanium dioxide
- Participation in a weight loss study within the past six (6) months
- Administration of GSP2, GSP3, Gelesis100, or Gelesis200 in a previous study
- Administration of investigational products within one (1) month prior to Screening Visit 1
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- Blood transfusion within three (3) months prior to Screening Visit 1
- Smoking cessation within six (6) months prior to Screening Visit 1 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 mild binge eating) or emesis ≥2/week from any cause within six (6) months prior to Screening Visit 1
- Weight change ≥3% within three (3) months prior to and during the Screening period
- Supine SBP >160 mm Hg and/or supine DBP >95 mm Hg
- Angina, coronary bypass, or myocardial infarction within six (6) months prior to Screening Visit 1
- History of swallowing disorders within six (6) months prior to Screening Visit 1
- Esophageal anatomic abnormalities (e.g., webs, diverticuli, rings)
- History of gastric or duodenal ulcer within six (6) months prior to Screening Visit 1
- History of gastroparesis (e.g., chronic nausea, vomiting ≥2 occurrences per week, heartburn, etc.) within six (6) months prior to Screening Visit 1
- History of gastric bypass or any other gastric surgery
- History of inflammatory bowel diseases
- 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 pancreatitis within six (6) months prior to Screening Visit 1
- History of malabsorption within six (6) months prior to Screening Visit 1
- Laxative users, except those on stable doses within one (1) month prior to Screening Visit 1
- History of hepatitis B or C within six (6) months prior to Screening Visit 1
- History of HIV
- History of cancer within the past five (5) years (except adequately-treated localized basal cell skin cancer or in situ uterine 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 TSH
- HbA1c >8.5% (>69 mmol/mol)
- Serum LDL cholesterol ≥160 mg/dL (≥4.15 mmol/L)
- Serum triglycerides ≥350 mg/dL (≥3.96 mmol/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 1
- Systemic corticosteroids within one (1) month prior to Screening Visit 1
- 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]
- TSH suppression therapy for thyroid cancer
- Estrogen within one (1) month prior to Screening Visit 1 [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 1
- 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]
- Change in medications treating hypertension within one (1) month [one (1) week for diuretics] prior to Screening Visit 1
- Change in medications treating dyslipidemia within one (1) month prior to Screening Visit 1
- 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
Trial locations and contacts
30 sites in 8 countries.
30 sites in 8 countries
United States12 sites
Central Alabama Research
Birmingham, Alabama, 35209
Meridien Research, Inc - Bradenton
Bradenton, Florida, 34201
Radiant Research
Cincinnati, Ohio, 45236
Mountain View Clinical Research - Greer
Greer, South Carolina, 29651
The Center for Pharmaceutical Research
Kansas City, Kansas, 64114
Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville
Knoxville, Tennessee, 37920
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104
Baptist Diabetes Associates, P.A.
Miami, Florida, 33156
Rainier Clinical Research Center
Renton, Washington, 98057
SAMCRC
San Antonio, Texas, 78229
Tarheel Clinical Research, LLC
Sugar Land, Texas, 77478
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401
Poland5 sites
NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
Bialystok, 15-435
NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek
Lodz, 94-048
MEDICOME Sp. z o.o.
Oświęcim, 32-600
Centrum Zdrowia Metabolicznego Pawel Bogdanski
Poznan, 60-589
Centrum Badawcze Wspolczesnej Terapii
Warsaw, 02-679
United Kingdom5 sites
Oakenhurst Medical Practice
Blackburn, BB21AX
Ashgate Medical Practice (Research Office)
Chesterfield, v
Aintree University Hospital
Liverpool, L9 7AL
The James Cook University Hospital
Middlesbrough, TS4 3 BW
Morriston Hospital
Swansea, SA6 6NL
Hungary3 sites
Qualiclinic Kft
Budapest, 1036
Debreceni Egyetem Klinikai Kozpont
Debrecen, H-4032
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5701
Canada2 sites
University of Ottawa - Institut de Recherche de l'Hospital d'Ottawa (IRHO) (Ottawa Hospital Research Institute (OHRI))
Ottawa, Ontario, K1N 6N5
Université Laval
Québec, Quebec, G1V 0A6
Denmark1 site
University of Copenhagen - Department of Nutrition, Exercise and Sports
Frederiksberg, 1958
About this study
Official 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
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
Read the detailed description
Multicenter, two-cohort, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose, adaptive (Two Phases).
In the first Phase of the adaptive design, unblinded interim analyses were conducted on 57 subjects and used to adjust the design for the second Phase. The first Phase was completed under protocol Version 1.0. Data used in the unblinded interim analyses of the first Phase will not be included in the second Phase (protocol Version 2.0 and subsequent protocol versions) analyses.
The study will evaluate the safety, tolerability and efficacy of Gelesis200 as a superabsorbent hydrogel for weight loss in treated diabetic subjects, untreated diabetic subjects, and prediabetic subjects (Cohort 1).
The study will evaluate separately the safety, tolerability and efficacy of Gelesis200 for weight loss in normoglycemic subjects (Cohort 2).
- Conditions
- Overweight, Diabetes, PreDiabetes, Obesity
- Being tested
- Gelesis200, Placebo
- Medical subject headings
- Overweight, Diabetes Mellitus, Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelesis200Device
Subject would take Gelesis200 capsules 2 times per day.
PlaceboDevice
Subject would take placebo capsules 2 times per day.
| Study group | Role | What they receive |
|---|---|---|
| Gelesis200 | Experimental | Gelesis200: Three (3) Gelesis200 capsules (2.10 gram (g)) two (2) times per day (id est (i.e.), lunch and dinner) Receives: Device: Gelesis200 |
| Placebo | Placebo comparator | Placebo: Three (3) placebo capsules two (2) times per day (i.e., lunch and dinner) Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with weight loss ≥5.0%
In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1)
Measured: Change from baseline to day 171 (week 25)
Percent change in body weight
In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1)
Measured: Change from baseline to day 171 (week 25)
Secondary outcomes (8)
Proportion of subjects with weight loss ≥10.0%
In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1)
Measured: Up to 25 weeks
Proportion of subjects with weight loss ≥10.0%
Treated diabetics (subgroup of Cohort 1)
Measured: Up to 25 weeks
Proportion of subjects with weight loss ≥10.0%
Pre-diabetics and untreated diabetics (subgroup of Cohort 1)
Measured: Up to 25 weeks
Proportion of subjects with weight loss ≥5.0%
Treated diabetic subjects (subgroup of Cohort 1)
Measured: Up to 25 weeks
Proportion of subjects with weight loss ≥5.0%
Pre-diabetics and untreated diabetics (subgroup of Cohort 1)
Measured: Up to 25 weeks
Percent change in FSI
Pre-diabetics and untreated diabetics (subgroup of Cohort 1)
Measured: Up to 25 weeks
Percent change in insulin AUC during OGTT
Pre-diabetic subjects (subgroup of Cohort 1)
Measured: Up to 25 weeks
Change in HbA1c
Diabetic subjects with HbA1c ≥7.5% (≥58 mmol/mol) at baseline (subgroup of Cohort 1)
Measured: Up to 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start22 Feb 2017
- Primary completion15 Jan 2021 (estimated)
- Study completion15 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gelesis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058029
- Sponsor's protocol ID
- GS-200-002
- Acronym
- LIGHT-UP
- Status last verified
- Jul 2020
- First submitted
- 13 Jan 2017
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03058029
- Acronym / sponsor ID
- LIGHT-UP / GS-200-002
- Conditions
- Overweight, Diabetes, PreDiabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Gelesis, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 15 Jan 2021 (estimated)
- First posted
- 20 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Multicenter, two-cohort, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose, adaptive (Two Phases).
In the first Phase of the adaptive design, unblinded interim analyses were conducted on 57 subjects and used to adjust the design for the second Phase. The first Phase was completed under protocol Version 1.0. Data used in the unblinded interim analyses of the first Phase will not be included in the second Phase (protocol Version 2.0 and subsequent protocol versions) analyses.
The study will evaluate the safety, tolerability and efficacy of Gelesis200 as a superabsorbent hydrogel for weight loss in treated diabetic subjects, untreated diabetic subjects, and prediabetic subjects (Cohort 1).
The study will evaluate separately the safety, tolerability and efficacy of Gelesis200 for weight loss in normoglycemic subjects (Cohort 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Gelesis200 | Experimental | Device: Gelesis200Gelesis200: Three (3) Gelesis200 capsules (2.10 gram (g)) two (2) times per day (id est (i.e.), lunch and dinner) |
| Placebo | Placebo comparator | Device: PlaceboPlacebo: Three (3) placebo capsules two (2) times per day (i.e., lunch and dinner) |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female
- Age ≥22 years and ≤65 years
- Ambulatory
- BMI ≥27 kg/M2 and ≤40 kg/M2
- Non-diabetic subjects, including:
Key exclusion criteria (46 listed)
- Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential)
- 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)
- History of allergic reaction to CMC, citric acid, sodium stearyl fumarate, maltodextrin, gelatin, or titanium dioxide
- Participation in a weight loss study within the past six (6) months
- Administration of GSP2, GSP3, Gelesis100, or Gelesis200 in a previous study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gelesis200Subject would take Gelesis200 capsules 2 times per day. | Device | Gelesis200 |
| PlaceboSubject would take placebo capsules 2 times per day. | Device | Placebo |
Primary outcome
Proportion of subjects with weight loss ≥5.0%
Time frame: Change from baseline to day 171 (week 25)
In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1)
Percent change in body weight
Time frame: Change from baseline to day 171 (week 25)
In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1)
8 secondary outcomes
Proportion of subjects with weight loss ≥10.0%
Time frame: Up to 25 weeks
Proportion of subjects with weight loss ≥10.0%
Time frame: Up to 25 weeks
Proportion of subjects with weight loss ≥10.0%
Time frame: Up to 25 weeks
Proportion of subjects with weight loss ≥5.0%
Time frame: Up to 25 weeks
Proportion of subjects with weight loss ≥5.0%
Time frame: Up to 25 weeks
Percent change in FSI
Time frame: Up to 25 weeks
Percent change in insulin AUC during OGTT
Time frame: Up to 25 weeks
Change in HbA1c
Time frame: Up to 25 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gelesis200 in people with Overweight and Diabetes, run by Gelesis, Inc. at 30 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Poland, United Kingdom, Hungary, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with weight loss ≥5.0% (time frame: Change from baseline to day 171 (week 25)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.