MedPath

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

Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery

Early Phase 1
Recruiting
Conditions
Bariatric Surgery Candidate
Bile Acid, Elevated Serum
Glucose Metabolism Disorders
Interventions
First Posted Date
2025-04-13
Last Posted Date
2025-04-13
Lead Sponsor
Hvidovre University Hospital
Target Recruit Count
18
Registration Number
NCT06925997
Locations
🇩🇰

Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark

Impact of Therapy Using Colesevelam Treatment Reducing Bile Acids in Patients With Fontan Circulation.

Phase 1
Not yet recruiting
Conditions
Fontan Circulation
Interventions
Other: Control Arm
First Posted Date
2024-01-09
Last Posted Date
2024-04-17
Lead Sponsor
St. Boniface Hospital
Target Recruit Count
50
Registration Number
NCT06197763

Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib

Phase 2
Active, not recruiting
Conditions
Hormone Receptor Positive
HER2 Positive Breast Cancer
Early-stage Breast Cancer
Interventions
First Posted Date
2022-02-23
Last Posted Date
2025-04-01
Lead Sponsor
Spanish Breast Cancer Research Group
Target Recruit Count
177
Registration Number
NCT05252988
Locations
🇪🇸

Hospital General Universitario de Elche, Elche, Alicante, Spain

🇪🇸

Hospital Costa del Sol, Málaga, Andalucía, Spain

🇪🇸

Hospital Clínico Universitario Lozano Blesa, Zaragoza, Aragón, Spain

and more 52 locations

Treatment of Bile Acid Malabsorption With Liraglutide

Phase 4
Completed
Conditions
Bile Acid Malabsorption
Interventions
First Posted Date
2019-05-20
Last Posted Date
2022-06-03
Lead Sponsor
Filip Krag Knop
Target Recruit Count
52
Registration Number
NCT03955575
Locations
🇩🇰

Gentofte Hospital, Hellerup, Regionh, Denmark

Effect of the Sequestrant Colesevelam in Bile Acid Diarrhoea

Phase 4
Completed
Conditions
Chronic Diarrhea
Bile Acid Malabsorption
Interventions
Drug: Placebo oral capsule
First Posted Date
2019-03-15
Last Posted Date
2022-08-23
Lead Sponsor
Lars Kristian Munck
Target Recruit Count
255
Registration Number
NCT03876717
Locations
🇩🇰

Aalborg University Hospital, Aalborg, Denmark

🇩🇰

Aarhus University Hospital, Aarhus, Denmark

🇩🇰

Hvidovre University Hospital, Hvidovre, Denmark

and more 1 locations

Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2019-02-27
Last Posted Date
2019-07-29
Lead Sponsor
Ironwood Pharmaceuticals, Inc.
Target Recruit Count
87
Registration Number
NCT03856970
Locations
🇺🇸

PPD, Austin, Texas, United States

A Study of Colesevelam for Lenalidomide-Associated Diarrhea

Phase 2
Completed
Conditions
Multiple Myeloma
Diarrhea
Interventions
First Posted Date
2018-12-06
Last Posted Date
2025-05-15
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
25
Registration Number
NCT03767257
Locations
🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

🇺🇸

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

and more 4 locations

A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)

Phase 3
Terminated
Conditions
Gastroesophageal Reflux Disease (GERD)
Interventions
Drug: placebo
Drug: Standard-dose PPIs QD
First Posted Date
2018-06-19
Last Posted Date
2021-08-19
Lead Sponsor
Ironwood Pharmaceuticals, Inc.
Target Recruit Count
495
Registration Number
NCT03561090
Locations
🇺🇸

Advanced Research Institute, Ogden, Utah, United States

🇺🇸

Medication Management LLC, Greensboro, North Carolina, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 96 locations

Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)

Phase 3
Completed
Conditions
Gastroesophageal Reflux Disease (GERD)
Interventions
Drug: placebo
Drug: Standard-dose PPIs QD
First Posted Date
2018-06-19
Last Posted Date
2021-08-18
Lead Sponsor
Ironwood Pharmaceuticals, Inc.
Target Recruit Count
609
Registration Number
NCT03561883
Locations
🇺🇸

Long Island Gastrointestinal Research Group LLP, Great Neck, New York, United States

🇺🇸

Carolina Digestive Diseases, Greenville, North Carolina, United States

🇺🇸

Morristown Medical Center, Morristown, New Jersey, United States

and more 96 locations

Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption

Phase 2
Completed
Conditions
Chronic Diarrhea
Irritable Bowel Syndrome With Diarrhea
Bile Acid Malabsorption
Interventions
Other: Placebo
First Posted Date
2017-09-01
Last Posted Date
2020-04-27
Lead Sponsor
Mayo Clinic
Target Recruit Count
30
Registration Number
NCT03270085
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

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