Nonalcoholic Fatty LiverREVERTNCT04887766
Study on GS300 on NAFLD
A study testing GS300 in people with Nonalcoholic Fatty Liver and Weight Loss, run by Gelesis, Inc..
Trial summary
To determine the efficacy of GS300 when administered for 24 weeks in patients with Nonalcoholic Fatty Liver Disease (NAFLD). Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Nonalcoholic Fatty Liver, Weight Loss
- What is being tested?
- GS300
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 31 Dec 2023
- 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
- Age ≥ 22 years and ≤ 65 years
- Body Mass Index (BMI) ≥ 27 and ≤ 40 kilogram (kg)/meter2 (m2)
- Negative for Hepatitis B, C and Human Immunodeficiency Virus (HIV) within 6 months of screening [HbsAg negative and Hepatitis C Virus (HCV) RNA negative; subjects treated and cured of HCV must have completed treatment and tested negative for HCV at least 2 years prior to study enrollment]
- Fibroscan CAP score > 300 decibels (dB)/m
- Stable body weight defined as less than 5% change in body weight in the 3 months prior to screening (per patient report)
- Approximately 250 patients (approximately 125 patients per treatment arm)
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- Prediabetes i) Untreated prediabetic patients with FPG ≥ 100 mg/ dL (≥ 5.6 mmol/L) and < 126 mg/dL (< 7.0 mmol/L) at both Screening Visits with HbA1c ≤ 6.4% (≤ 46 mmol/mol) - if only one 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) ii) Drug-treated (metformin) prediabetic patients with FPG ≥ 70 mg/dL (≥ 3.9 mmol/L) and < 126 mg/dL (< 7.0 mmol/L) at both Screening Visits
- Type 2 Diabetes i) Untreated type 2 diabetic patients 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 or both Screening Visits with HbA1c ≥ 6.5% (≥ 48 mmol/mol) ii) Drug-treated [metformin and/or dipeptidyl peptidase-4 (DPP-4) inhibitors, and/or insulin] type 2 diabetic patients with FPG ≥ 70 mg/dL (≥ 3.9 mmol/L) and ≤ 270 mg/dL (≤ 15.1 mmol/L) at both Screening Visits Note, approximately 10% to 20% of enrolled Type 2 diabetic patients will be on insulin therapy
- Normoglycemia (up to approximately 10% of patients) Normoglycemic patients with FPG ≥ 70 mg/dL (≥ 3.9 mmol/L) and < 100 mg/ dL (< 5.6 mmol/L) at both Screening Visits with HbA1c < 5.7% (< 39 mmol/mol) and HOMA-IR ≥ 3.0
- MRI PDFF ≥ 10%
- Willing to sign the ICF prior to any study related procedures
Who cannot join
- Self-reported alcohol intake > 20 gram (g)/day for women and > 30 g/day for men (on average per day) as per medical history
- Alcohol Use Disorders Identification Test (AUDIT) questionnaire: AUDIT-C score of ≥ 4 in men and ≥ 3 in women will be followed by a full AUDIT questionnaire by interview with patients excluded for score ≥ 8
- Prior liver transplant
- Liver cirrhosis as evidenced by any of the following:
- Serum albumin < 3.5 g/dL (0.53 mmol/L)
- INR > 1.3 (unless due to anticoagulant therapy)
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- AST/ALT ratio ≥ 2
- Direct bilirubin > 0.3 mg/dL (5.13 micromol (micromol)/L)
- Platelet count < 150,000/microL
- History or evidence of other chronic liver diseases, including, but not limited to the following:
- Current active autoimmune hepatitis
- Primary biliary cholangitis (PBC)
- Primary sclerosing cholangitis
- Wilson's disease
- Alpha-1-antitrypsin (A1AT) deficiency
- Hemochromatosis
- Drug-induced liver disease, as defined on the basis of typical exposure and history
- Bile duct obstruction
- Suspected or proven liver cancer
- History of hepatic encephalopathy
- Portal hypertension (esophageal varices, ascites, splenomegaly)
- History of gastric surgery (up to 10% patients with history of gastric bypass or sleeve gastrectomy may be enrolled if the surgery occurred more than 6 months prior to enrollment and patients had a weight change < 5% during the 3 months prior to enrollment)
- Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
- Inflammatory bowel disease, celiac disease, or other significant gastrointestinal disease - for example, a history of bowel obstruction without surgical correction (patients with irritable bowel syndrome may be enrolled)
- Pregnancy
- Absence of medically approved contraceptive methods in females of childbearing potential (e.g., hysterectomy, oral contraceptives, non-oral contraceptive medications or intrauterine device combined with a barrier method, two combined barrier methods such as diaphragm and condom or spermicide, or condom and spermicide; bilateral tubal ligation and vasectomy are not acceptable methods)
- Type 1 Diabetes
- HbA1c > 8.5% (> 69 mmol/mol)
- Serum LDL-C ≥ 160 mg/dL (≥ 4.15 mmol/L)
- Serum triglycerides ≥ 350 mg/dL (≥ 3.96 mmol/L)
- Use of any medications for the treatment of diabetes within 3 months prior to enrollment. Note, metformin, DPP-4 inhibitors, and insulin at a stable dose over the last 3 months are allowed. Insulin dose variance of 20% (decrease or increase) is allowed.
- Any change in standard of care or background therapy for liver disease or other ongoing chronic conditions within 3 months prior to enrollment, including changes in the following:
- Antidiabetic medications (metformin, DPP-4 inhibitors, insulin)
- Thyroid hormones
- Medications treating depression
- Medications treating dyslipidemia
- Medications treating hypertension
- Vitamin E
- Regular/daily use of any of the following within 3 months prior to enrollment or anticipated regular/daily use during the study period:
- High dose nonsteroidal anti-inflammatory drugs (NSAIDS) (equivalent of > 3,200 mg/day ibuprofen)
- Systemic corticosteroids, anabolic steroids
- Methotrexate, amiodarone, tamoxifen, tetracyclines, estrogens at doses greater than those used for hormone replacement, valproic acid
- Probiotic supplements (yogurt is allowed)
- Addictive, non-prescribed medications including amphetamines, barbiturates, cocaine, opiates, methadone and phencyclidine as per medical history or regular daily use of cannabinoids
- Use of any anti-obesity medications (including herbal preparations) within 2 months prior to enrollment or any anticipated use during the study period
- History of allergic reaction to carboxymethylcellulose (CMC), citric acid, sodium stearyl fumarate, raw cane sugar, gelatin, or titanium dioxide
- Currently enrolled in another investigational device or drug study, or less than 3 months since ending another investigational device or drug study(s), or receiving other investigational treatment(s)
- Any disease or condition that, in the opinion of the investigator or Sponsor, would interfere with study participation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of GS300 on Nonalcoholic Fatty Liver Disease
To determine the efficacy of GS300 when administered for 24 weeks in patients with Nonalcoholic Fatty Liver Disease (NAFLD).
Read the detailed description
This is a multicenter, randomized, placebo-controlled, double-blinded, parallel-group study. Patients will be randomized 1:1 to receive either GS300 or placebo. The study includes an up to 6 weeks screening period, a 24-week treatment period, and a 1-week follow-up period.
Approximately 250 patients (125 patients per arm) will be enrolled (at least 40% from each gender and at least 40% from US and 40% from Europe).
- Conditions
- Nonalcoholic Fatty Liver, Weight Loss
- Being tested
- GS300, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS300Device
Gelesis300 hydrogel in gelatin capsules
PlaceboDevice
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | GS300: Three (3) GS300 capsules [approximately 0.65 grams (g)] two (2) times per day ingested 10 minutes (min) before meals (i.e., lunch and dinner) - total of 3.9 g per day Receives: Device: GS300 |
| Placebo | Placebo comparator | Placebo: Three (3) placebo capsules two (2) times per day 10 min before meals (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.
Weight loss ≥ 5%
Proportion of patients with weight loss ≥ 5% at Week 24.
Measured: 24 Weeks
Placebo-adjusted percent change in weight from Baseline to Week 24
Placebo-adjusted percent change in weight from Baseline to Week 24.
Measured: 24 Weeks
Relative reduction in liver fat
Relative reduction in liver fat from Baseline to Week 24, as measured by hepatic Magnetic Resonance Imaging Proton Density Fat Fraction (MRI PDFF).
Measured: 24 Weeks
Secondary outcomes (6)
Weight loss ≥ 7.5%
To assess reduction in weight (≥ 7.5%) in patients with NAFLD treated with GS300 or placebo.
Measured: 24 Weeks
Weight loss ≥ 10%
To assess reduction in weight (≥ 10%) in patients with NAFLD treated with GS300 or placebo.
Measured: 24 Weeks
To evaluate the percentage of patients with ≥ 30% relative reduction in liver fat
To evaluate the percentage of patients with ≥ 30% relative reduction in liver fat in patients treated with GS300 or placebo.
Measured: 24 Weeks
To assess placebo-adjusted waist circumference reduction
To assess placebo-adjusted waist circumference reduction after 24 weeks of treatment with GS300 or placebo.
Measured: 24 Weeks
To assess the impact of GS300 on glycemic control in patients with NAFLD
To assess the impact of GS300 on glycemic control in patients with NAFLD treated with GS300 or placebo.
Measured: 24 Weeks
To assess the impact of GS300 on liver enzymes in patients with NAFLD
To assess the impact of GS300 on liver enzymes in patients with NAFLD treated with GS300 or placebo.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 Jul 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty LiverStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gelesis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan M Heshmati, MD, Study director, Gelesis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887766
- Sponsor's protocol ID
- GS-300-001
- Acronym
- REVERT
- Status last verified
- Jan 2022
- First submitted
- 11 May 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 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 Effect of GS300 on Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT04887766
- Acronym / sponsor ID
- REVERT / GS-300-001
- Conditions
- Nonalcoholic Fatty Liver, Weight Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Gelesis, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 May 2021 (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.
To determine the efficacy of GS300 when administered for 24 weeks in patients with Nonalcoholic Fatty Liver Disease (NAFLD).
Detailed description
This is a multicenter, randomized, placebo-controlled, double-blinded, parallel-group study. Patients will be randomized 1:1 to receive either GS300 or placebo. The study includes an up to 6 weeks screening period, a 24-week treatment period, and a 1-week follow-up period.
Approximately 250 patients (125 patients per arm) will be enrolled (at least 40% from each gender and at least 40% from US and 40% from Europe).
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 |
|---|---|---|
| Active | Active comparator | Device: GS300GS300: Three (3) GS300 capsules [approximately 0.65 grams (g)] two (2) times per day ingested 10 minutes (min) before meals (i.e., lunch and dinner) - total of 3.9 g per day |
| Placebo | Placebo comparator | Device: PlaceboPlacebo: Three (3) placebo capsules two (2) times per day 10 min before meals (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 (11 listed)
- Age ≥ 22 years and ≤ 65 years
- Body Mass Index (BMI) ≥ 27 and ≤ 40 kilogram (kg)/meter2 (m2)
- Negative for Hepatitis B, C and Human Immunodeficiency Virus (HIV) within 6 months of screening [HbsAg negative and Hepatitis C Virus (HCV) RNA negative; subjects treated and cured of HCV must have completed treatment and tested negative for HCV at least 2 years prior to study enrollment]
- Fibroscan CAP score > 300 decibels (dB)/m
- Stable body weight defined as less than 5% change in body weight in the 3 months prior to screening (per patient report)
Key exclusion criteria (48 listed)
- Self-reported alcohol intake > 20 gram (g)/day for women and > 30 g/day for men (on average per day) as per medical history
- Alcohol Use Disorders Identification Test (AUDIT) questionnaire: AUDIT-C score of ≥ 4 in men and ≥ 3 in women will be followed by a full AUDIT questionnaire by interview with patients excluded for score ≥ 8
- Prior liver transplant
- Liver cirrhosis as evidenced by any of the following:
- History or evidence of other chronic liver diseases, including, but not limited to the following:
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 |
|---|---|---|
| GS300Gelesis300 hydrogel in gelatin capsules | Device | Active |
| PlaceboPlacebo capsules | Device | Placebo |
Primary outcome
Weight loss ≥ 5%
Time frame: 24 Weeks
Proportion of patients with weight loss ≥ 5% at Week 24.
Placebo-adjusted percent change in weight from Baseline to Week 24
Time frame: 24 Weeks
Placebo-adjusted percent change in weight from Baseline to Week 24.
Relative reduction in liver fat
Time frame: 24 Weeks
Relative reduction in liver fat from Baseline to Week 24, as measured by hepatic Magnetic Resonance Imaging Proton Density Fat Fraction (MRI PDFF).
6 secondary outcomes
Weight loss ≥ 7.5%
Time frame: 24 Weeks
Weight loss ≥ 10%
Time frame: 24 Weeks
To evaluate the percentage of patients with ≥ 30% relative reduction in liver fat
Time frame: 24 Weeks
To assess placebo-adjusted waist circumference reduction
Time frame: 24 Weeks
To assess the impact of GS300 on glycemic control in patients with NAFLD
Time frame: 24 Weeks
To assess the impact of GS300 on liver enzymes in patients with NAFLD
Time frame: 24 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
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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 M Heshmati, MD study director
Gelesis, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing GS300 in people with Nonalcoholic Fatty Liver and Weight Loss, run by Gelesis, Inc..
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 11 inclusion and 48 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 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Valerie Colletta (1-857-201-5330, vcolletta@gelesis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss ≥ 5% (time frame: 24 Weeks). The study lists 3 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 24 Jan 2022.