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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
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The purpose of the study is to see if the drug colesevelam is a potential treatment for Nonalcoholic Steatohepatitis(NASH).
We plan to investigate the role of colesevelam, a bile-acid binding resin, in patients with NASH residing in the United States and assess liver fat changes during therapy using MRI of the liver. It can be hypothesized that colesevelam would lead to a greater improvement in insulin sensitivity and lipid profile compared with placebo and may lead to greater improvement in liver fat by MRI as compared to placebo.
In this pilot study, we propose to randomize approximately 55 patients (1:1 ratio) to either colesevelam or placebo and treat them for 24-weeks to evaluate changes in baseline insulin sensitivity, serum biochemistry (ALT and AST), and liver fat by MRI during therapy. Liver histologic changes would also be examined as an exploratory outcome for future studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (sugar) pill | Placebo Comparator | Six tablets per day (identical to colesevelam) |
|
| Colesevelam arm | Experimental | 3.75 grams per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colesevelam Hcl | Drug | 3.75 gm/day (six 675 mg tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Will be Improvement in Hepatic Steatosis by Liver MRI | To examine the efficacy of Colesevelam at 3.75 g/day orally versus placebo to decrease liver fat in patients with biopsy-proven nonalcoholic steatohepatitis. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity as Determined by HOMA-IR | To examine the efficacy of Colesevelam at 3.75 g/day orally versus placebo to decrease HOMA-IR in patients with biopsy-proven nonalcoholic steatohepatitis. | 24 weeks |
| Serum ALT and AST Values |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rohit Loomba, MD, M.H.Sc | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD: Prevention Studies Clinic | La Jolla | California | 92093 | United States | ||
| UCSD: Medical Center- Hillcrest |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36318027 | Derived | Nedrud MA, Chaudhry M, Middleton MS, Moylan CA, Lerebours R, Luo S, Farjat A, Guy C, Loomba R, Abdelmalek MF, Sirlin CB, Bashir MR. MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials. Radiology. 2023 Mar;306(3):e220743. doi: 10.1148/radiol.220743. Epub 2022 Nov 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Sugar) Pill | Six tablets per day (identical to colesevelam) Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets) |
| FG001 | Colesevelam Arm | 3.75 grams per day Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (Sugar) Pill | Six tablets per day (identical to colesevelam) Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets) |
| BG001 | Colesevelam Arm | 3.75 grams per day Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Outcome Will be Improvement in Hepatic Steatosis by Liver MRI | To examine the efficacy of Colesevelam at 3.75 g/day orally versus placebo to decrease liver fat in patients with biopsy-proven nonalcoholic steatohepatitis. | Posted | Mean | Standard Deviation | % of fat | 24 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Sugar) Pill | Six tablets per day (identical to colesevelam) Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle ache with elevated CPK | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rohit Loomba, MD | UCSD | 858-246-2201 | roloomba@ucsd.edu |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069472 | Colesevelam Hydrochloride |
| ID | Term |
|---|---|
| D000499 | Allylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000498 | Allyl Compounds |
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To examine the efficacy of Colesevelam at 3.75 g/day orally versus placebo to decrease serum ALT and AST in patients with biopsy-proven nonalcoholic steatohepatitis.
| 24 weeks |
| Lipid Profiles | To examine the efficacy of Colesevelam at 3.75 g/day orally versus placebo to decrease improve the lipid profiles in patients with biopsy-proven nonalcoholic steatohepatitis. | 24 weeks |
| San Diego |
| California |
| 92103 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Insulin Sensitivity as Determined by HOMA-IR | To examine the efficacy of Colesevelam at 3.75 g/day orally versus placebo to decrease HOMA-IR in patients with biopsy-proven nonalcoholic steatohepatitis. | Posted | Mean | Standard Deviation | units on a scale | 24 weeks |
|
|
|
| Secondary | Serum ALT and AST Values | To examine the efficacy of Colesevelam at 3.75 g/day orally versus placebo to decrease serum ALT and AST in patients with biopsy-proven nonalcoholic steatohepatitis. | Posted | Mean | Standard Deviation | U/L | 24 weeks |
|
|
|
| Secondary | Lipid Profiles | To examine the efficacy of Colesevelam at 3.75 g/day orally versus placebo to decrease improve the lipid profiles in patients with biopsy-proven nonalcoholic steatohepatitis. | Posted | Mean | Standard Deviation | mg/dL | 24 weeks |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 2 |
| 25 |
| EG001 | Colesevelam Arm | 3.75 grams per day Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets) | 0 | 25 | 0 | 25 | 1 | 25 |
| Severe hot flashes with leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| IBD Exacerbation | Gastrointestinal disorders | Systematic Assessment |
|
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| D000475 |
| Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |