Colesevelam

Generic Name: Colesevelam

Brand Names: Cholestagel, Lodalis, Welchol

Drug Type: Small Molecule

Chemical Formula: -

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

Associated Therapies: -

Clinical Trials

The Role of Metformin and Colesevelam in Human GLP-1 Secretion

Phase 4

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Colesevelam
Drug: Metformin
Other: Placebo

First Posted Date: 2014-01-30

Last Posted Date: 2014-10-07

Lead Sponsor: University Hospital, Gentofte, Copenhagen

Target Recruit Count: 12

Registration Number: NCT02050074

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

Effects of Fish Oil and Colesevelam (STAIR7007)

Not Applicable

Conditions: Sitosterolemia

Interventions: Drug: Colesevelam
Dietary Supplement: Fish Oil
Drug: Combination of fish oil and colesevelam

First Posted Date: 2013-09-23

Last Posted Date: 2020-11-10

Lead Sponsor: University of Manitoba

Target Recruit Count: 13

Registration Number: NCT01948648

Locations: 🇨🇦
Richardson Center for Functional Foods and Nutraceuticals, Winnipeg, Manitoba, Canada

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 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

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

The Effect of Welchol on Glucose Metabolism in Type 2 Diabetics

Phase 4

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Colesevelam
Other: Placebo
Behavioral: Diet
Drug: Metformin

First Posted Date: 2009-08-04

Last Posted Date: 2013-11-11

Lead Sponsor: Mayo Clinic

Target Recruit Count: 38

Registration Number: NCT00951899

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Efficacy of Colesevelam in Subjects With Type 1 Diabetes Mellitus

Not Applicable

Completed

Conditions: Diabetes Mellitus, Type 1
Hyperlipidemias

Interventions: Drug: Placebo
Drug: Colesevelam HCl

First Posted Date: 2009-07-13

Last Posted Date: 2014-05-20

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 45

Registration Number: NCT00938405

Locations: 🇺🇸
Barbara Davis Center for Diabetes, Aurora, Colorado, United States

Does Welchol (Colesevelam Hydrochloride) Improve Colonic Transit in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)?

Phase 2

Completed

Conditions: Irritable Bowel Syndrome
Diarrhea

Interventions: Drug: Placebo
Drug: Colesevelam

First Posted Date: 2009-06-02

Last Posted Date: 2012-04-04

Lead Sponsor: Mayo Clinic

Target Recruit Count: 24

Registration Number: NCT00911612

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

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