DeepMed Research

Colesevelam

Generic Name: Colesevelam

Brand Names: Cholestagel, Lodalis, Welchol

Drug Type: Small Molecule

CAS Number: 182815-43-6

Unique Ingredient Identifier: 1XU104G55N

Background: Colesevelam is a bile acid sequestrant. Colesevelam is used with exercise and diet changes (restriction of cholesterol and fat intake) to reduce the amount of cholesterol and certain fatty substances in the blood. It works by binding bile acids in the intestine. Bile acids are made when cholesterol is broken down in the body. Removing these bile acids helps to lower blood cholesterol.

Indication: 用于以胆固醇升高为主的高脂血症，当饮食和锻炼不能良好达到效果者，可单独使用或与他汀类合用。

Associated Conditions: Heterozygous Familial Hypercholesterolemia (HeFH), Hyperlipidemias, Type 2 Diabetes Mellitus, Primary Hyperlipidemia

Clinical Trials

Effect of Bile Acids on GLP-1 Secretion

Not Applicable

Completed

Conditions: Type 2 Diabetes
Obesity

Interventions: Drug: Colesevelam 3750 mg + chenodeoxycholic acid 1250 mg
Other: saline
Drug: Colesevelam
Drug: Chenodeoxycholic Acid

First Posted Date: 2012-08-16

Last Posted Date: 2013-12-24

Lead Sponsor: University Hospital, Gentofte, Copenhagen

Target Recruit Count: 20

Registration Number: NCT01666223

Locations: 🇩🇰
Diabetes Research Division, Department of Internal Medicine, Gentofte Hospital, University of Copenhagen, Hellerup, Copenhagen, Denmark

The Impact of Gall Bladder Emptying and Bile Acids on the Human GLP-1-secretion

Not Applicable

Completed

Conditions: To Assess the Impact of Bile Acids on Human Glukagon-like-peptide-1 Secretion

Interventions: Drug: Acetaminophen
Other: Saline
Other: Cholecystokinin-8
Drug: Colesevelam
Drug: Metformin

First Posted Date: 2012-08-02

Last Posted Date: 2015-07-14

Lead Sponsor: Filip Krag Knop

Target Recruit Count: 10

Registration Number: NCT01656057

Locations: 🇩🇰
University Hospital of Copenhagen, Gentofte Hospital, Diabetic Research Division, Copenhagen, Hellerup, Denmark

Colesevelam for Children With Type 2 Diabetes

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: High-dose colesevelam
Drug: Low-dose colesevelam

First Posted Date: 2010-12-10

Last Posted Date: 2021-05-13

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 236

Registration Number: NCT01258075

Colesevelam Treatment for Impaired Fasting Glucose During Niacin Therapy

Phase 4

Completed

Conditions: Dyslipidemia
Hyperlipidemia
Hyperglycemia

Interventions: Drug: Placebo
Drug: Colesevelam

First Posted Date: 2010-11-11

Last Posted Date: 2012-01-06

Lead Sponsor: Radiant Research

Target Recruit Count: 140

Registration Number: NCT01239004

Locations: 🇺🇸
Radiant Research, Chicago, Illinois, United States

Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease

Phase 4

Terminated

Conditions: Crohns Disease
Bile Acid Malabsorption

Interventions: Drug: Placebo
Drug: Colesevelam

First Posted Date: 2010-09-16

Last Posted Date: 2013-04-18

Lead Sponsor: Florian Beigel

Target Recruit Count: 34

Registration Number: NCT01203254

Locations: 🇩🇪
Praxis Dr. Mroß, Berlin, Germany
🇩🇪
Hochschulambulanz Med. Klinik I - Charite-, Berlin, Germany
🇩🇪
Hamburgisches Forschungsinstitut für CED, Hamburg, Germany

and more 3 locations

Comparison of Colesevelam Hydrogen Chloride (HCl) Powder For Oral Suspension Versus Generic Cholestyramine Through Use of the Bile Acid Sequestrant Acceptability (BASA) Scale

Phase 4

Completed

Conditions: Healthy

Interventions: Drug: Cholestyramine
Drug: Colesevelam HCl

First Posted Date: 2010-05-13

Last Posted Date: 2010-10-07

Lead Sponsor: Louisville Metabolic and Atherosclerosis Research Center

Target Recruit Count: 42

Registration Number: NCT01122108

Locations: 🇺🇸
L-MARC Research Center, Louisville, Kentucky, United States

The Effects of Co-admin of Colesevelam and Sitagliptin on Glucose Metabolism in Subjects With Type 2 Diabetes Mellitus

Not Applicable

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Colesevelam HCl
Drug: Sitagliptin

First Posted Date: 2010-03-25

Last Posted Date: 2013-01-17

Lead Sponsor: KineMed

Target Recruit Count: 61

Registration Number: NCT01092663

Locations: 🇺🇸
Healthcare Discoveries, LLC d/b/a ICON Development Solutions, San Antonio, Texas, United States
🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
Clinical Pharmacology of Miami, Miami, Florida, United States

Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

Phase 2

Completed

Conditions: Nonalcoholic Steatohepatitis

Interventions: Drug: Colesevelam Hcl

First Posted Date: 2010-02-10

Last Posted Date: 2020-07-21

Lead Sponsor: University of California, San Diego

Target Recruit Count: 59

Registration Number: NCT01066364

Locations: 🇺🇸
UCSD: Medical Center- Hillcrest, San Diego, California, United States
🇺🇸
UCSD: Prevention Studies Clinic, La Jolla, California, United States

Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes

Phase 2

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: colesevelam HCl
Drug: placebo

First Posted Date: 2009-10-14

Last Posted Date: 2015-11-30

Lead Sponsor: HealthPartners Institute

Target Recruit Count: 21

Registration Number: NCT00993824

Locations: 🇺🇸
International Diabetes Center, Minneapolis, Minnesota, United States

Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)

Phase 3

Completed

Conditions: Impaired Fasting Glucose
Prediabetes

Interventions: Drug: Colesevelam
Other: placebo

First Posted Date: 2009-10-06

Last Posted Date: 2012-11-21

Lead Sponsor: Seattle Institute for Biomedical and Clinical Research

Target Recruit Count: 21

Registration Number: NCT00990184

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