Overweight and ObesityMATCHNCT03622424

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

A study testing Gelesis200 in people with Overweight and Obesity and PreDiabetes, run by Gelesis, Inc. at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 22 to 65 years
Conditions the study is for: Overweight and Obesity, PreDiabetes, Type2 Diabetes
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: 16 participants
Where: 1 siteDenmark
Study dates: 22 Aug 2017to 20 Dec 2019
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 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

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 [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

Show all 49Show fewer

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)
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 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 thyroid-stimulating hormone (TSH)
HbA1c >8.5% (>69 mmol/mol)
Serum low-density lipoprotein (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
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 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

University of Copenhagan
Frederiksberg, DK-1958

Other trials in Denmark

About this study

Official title: 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 Subjects With or Without Diabetes: A Sub-Study of LIGHT-UP

Read the detailed description

Overweight (BMI ≥25 and <30kg/M2) and obesity (BMI ≥30kg/M2) are major health problems, world-wide. The overweight/obesity epidemic was first noted in the US and then spread to other industrialized nations, and is now seen even in developing countries. The World Health Organization (WHO) estimated that the worldwide prevalence of obesity has nearly doubled between 1980 and 2008, and in a separate analysis, the NCD Risk Factor Collaboration (NCD RisC) and the WHO estimated that the worldwide prevalence of diabetes has nearly quadrupled between 1980 and 2014, from 108 million to 422 million, respectively.

The intra-gastric balloon is an intervention designed to reduce stomach volume, but there are conflicting data on sustained weight loss and no clear data indicating a decrease in mortality. Side effects include balloon movement, nausea, vomiting, pain, and stomach ulceration. The results from bariatric surgery suggest that limiting the functional volume of the stomach is an effective modality for the treatment of obesity. However, because of the invasive nature of the procedure, associated risk of peri-operative complications and the relatively high cost, bariatric surgery is usually reserved for the severely obese subjects. A need exists for a product that is easy to use, safe, convenient, more accessible, and effective at inducing and sustaining weight loss. Interventions which act mechanically by occupying stomach volume, increasing the elasticity and viscosity of the upper gastrointestinal content, and extending gastric emptying time, could potentially be very beneficial.A medical device which induces satiety and decreases hunger could result in decreased caloric intake and weight loss. The advantage of such a medical device is that it would not require drastic restriction of food choices and would circumvent the challenge of unacceptable hunger levels which have derailed so many dietary interventions in the past.

Gelesis200, when hydrated, is homogeneously mixed with the ingested food,increasing the volume and elasticity of the stomach and small intestine contents. This in turn may induce satiety,which reduces food intake. Previous studies with a similar hydrogel (Gelesis100) have shown increased satiety,reduced body weight(especially in prediabetics), and improved glycemic control. It is expected that Gelesis200 will have similar effects to Gelesis100. Furthermore, the physical properties of Gelesis200 (viscosity), which are similar to some dietary fibers, suggest that Gelesis200 will have a favorable impact on glycemic control.

Conditions: Overweight and Obesity, PreDiabetes, Type2 Diabetes
Being tested: Gelesis200, Placebo, Gelesis200 and Placebo
Medical subject headings: Overweight, Obesity, Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gelesis200Device
Gelesis200: Three (3)Gelesis200 capsules (2.10 g) three (3) times per day (i.e., breakfast, lunch, and dinner)
PlaceboDevice
Placebo: Three (3)placebo capsules three (3) times per day (i.e., breakfast, lunch, and dinner)
Gelesis200 and PlaceboDevice
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)

Study groups in NCT03622424
Study group	Role	What they receive
Gelesis200	Active comparator	Subjects on this ARM will receive Gelesis200 Receives: Device: Gelesis200
Placebo	Placebo comparator	Subjects on this ARM will receive a placebo device Receives: Device: Placebo
Gelesis200 and Placebo	Active comparator	Subejcts on this ARM will receive both Gelesis200 and placebo. Receives: Device: Gelesis200 and Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 26 weeks

Secondary outcomes (2)

statistically significant improvement in HbA1c comparing Gelesis200 to placebo in diabetic subjects
Gelesis is observing if subject on Gelesis200 improved their HbA1c better than those on placebo.
Measured: 26 weeks
improvement in FPG status, post-OGTT plasma glucose status, or post-OGTT plasma glucose AUC in ≥50% of subjects on Gelesis200.
Gelesis is observing if greater than 50% of subject on Gelesis200 improved FPG status, post-OGTT plasma glucose status, or post-OGTT plasma glucose AUC.
Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 201720 Dec 2019

First posted9 Aug 2018
Study start22 Aug 2017
Primary completion19 Nov 2019
Study completion20 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Overweight and ObesityStudies 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: 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
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03622424
Sponsor's protocol ID: GS-200-003
Acronym: MATCH
Status last verified: Apr 2022
First submitted: 12 Sep 2017
Last updated: 4 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bessesen DH. Update on obesity. J Clin Endocrinol Metab. 2008 Jun;93(6):2027-34. doi: 10.1210/jc.2008-0520.
PubMed 18539769
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.
PubMed 27061677
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.
PubMed 8363192

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2022. 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 Effects of Gelesis200 on Appetite Parameters, Food Intake, and Glycemic Control in Overweight or Obese Subjects With or Without Diabetes: A Sub-Study of LIGHT-UP
ClinicalTrials.gov ID: NCT03622424
Acronym / sponsor ID: MATCH / GS-200-003
Conditions: Overweight and Obesity, PreDiabetes, Type2 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Gelesis, Inc.Industry (pharma, biotech, devices)
Collaborators: University of Copenhagen
Study start: 22 Aug 2017 (actual)
Primary completion: 19 Nov 2019 (actual)
Study completion: 20 Dec 2019 (actual)
First posted: 9 Aug 2018 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3
Model description: 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

Arm	Type	Receives
Gelesis200	Active comparator	Device: Gelesis200Subjects on this ARM will receive Gelesis200
Placebo	Placebo comparator	Device: PlaceboSubjects on this ARM will receive a placebo device
Gelesis200 and Placebo	Active comparator	Device: Gelesis200 and PlaceboSubejcts on this ARM will receive both Gelesis200 and placebo.

Who may qualify

Ages: 22 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (49 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 [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

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
Gelesis200Gelesis200: Three (3)Gelesis200 capsules (2.10 g) three (3) times per day (i.e., breakfast, lunch, and dinner)	Device	Gelesis200
PlaceboPlacebo: Three (3)placebo capsules three (3) times per day (i.e., breakfast, lunch, and dinner)	Device	Placebo
Gelesis200 and PlaceboPlacebo 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)	Device	Gelesis200 and Placebo

Primary outcome

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.
Time frame: 26 weeks
Gelesis is observing if subject loose 3% or more of their body weight as a result of their participating in the study.
weight loss of >5.0% in at least 35% of prediabetic subjects or in at least 25% of diabetic subjects on Gelesis200.
Time frame: 26 weeks
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.

2 secondary outcomes

statistically significant improvement in HbA1c comparing Gelesis200 to placebo in diabetic subjects
Time frame: 26 weeks
improvement in FPG status, post-OGTT plasma glucose status, or post-OGTT plasma glucose AUC in ≥50% of subjects on Gelesis200.
Time frame: 26 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
Background: PubMed 18539769Bessesen DH. Update on obesity. J Clin Endocrinol Metab. 2008 Jun;93(6):2027-34. doi: 10.1210/jc.2008-0520.
Background: PubMed 27061677NCD 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.
Background: PubMed 8363192Pi-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.
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.

Hassan Heshmati, MD study director

Gelesis, Inc.

1 site in 1 country: 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 Obesity and PreDiabetes, run by Gelesis, Inc. at 1 site in Denmark.

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 7 inclusion and 49 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: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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. (time frame: 26 weeks). 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?

On the ClinicalTrials.gov record for NCT03622424, which also lists 3 linked publications.

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 4 Apr 2022.