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ClinicalTrials.gov public records Last synced Oct 30, 2026, 7:01 AM EDT

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Showing 1–24 of 36 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Colesevelam HCL Clear all
Recruiting Phase 1Phase 2 Interventional

Examining a Novel Gastrointestinal Intervention to Negate Environmental Toxicants (ENGINE)

NCT07226440
View directory record Official record
Conditions
Toxicant Exposure, Firefighter, Occupational Exposure to Chemicals
Interventions
Colesevelam, Placebo
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
18 Years and older · Male only
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Apr 24, 2026 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 2Phase 3 Interventional Results available

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

NCT00993824
View directory record Official record
Conditions
Type 2 Diabetes
Interventions
colesevelam HCl, placebo
Drug
Lead sponsor
HealthPartners Institute
Other
Eligibility
18 Years to 75 Years
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
1
States / cities
Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Nov 30, 2015 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 3 Interventional

Long-Term Study of Safety and Efficacy of WelChol® as an Additional Therapy in Patients With Type 2 Diabetes

NCT00151762
View directory record Official record
Conditions
Type 2 Diabetes
Interventions
Colesevelam hydrochloride
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
18 Years to 75 Years
Enrollment
780 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2007
U.S. locations
62
States / cities
Birmingham, Alabama • Tuscumbia, Alabama • Jonesboro, Arkansas + 59 more
Source: ClinicalTrials.gov public record
Updated Jan 9, 2008 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 4 Interventional

Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol

NCT00185107
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Colesevelam Hydrochloride, Ezetimibe, Simvastatin
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
18 Years to 80 Years
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005
U.S. locations
7
States / cities
San Diego, California • Ocala, Florida • Overland Park, Kansas + 4 more
Source: ClinicalTrials.gov public record
Updated Sep 11, 2007 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Not applicable Interventional Results available

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

NCT01092663
View directory record Official record
Conditions
Diabetes Mellitus, Type 2
Interventions
Colesevelam HCl, Sitagliptin
Drug
Lead sponsor
KineMed
Industry
Eligibility
18 Years to 80 Years
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
3
States / cities
San Francisco, California • Miami, Florida • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Jan 17, 2013 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 3 Interventional Results available

Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients.

NCT00570739
View directory record Official record
Conditions
Type 2 Diabetes Mellitus, Hypercholesterolemia, Pre-diabetes
Interventions
Metformin HCl and Colesevelam Placebo, Metformin HCl tablets and Colesevelam tablets, Colesevelam placebo, Colesevelam
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
18 Years to 79 Years
Enrollment
502 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2009
U.S. locations
17
States / cities
Birmingham, Alabama • Los Gatos, California • Tarzana, California + 14 more
Source: ClinicalTrials.gov public record
Updated Jul 27, 2010 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 2 Interventional Results available

A Study of Colesevelam for Lenalidomide-Associated Diarrhea

NCT03767257
View directory record Official record
Conditions
Multiple Myeloma, Diarrhea
Interventions
Colesevelam Pill
Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
7
States / cities
Basking Ridge, New Jersey • Middletown, New Jersey • Montvale, New Jersey + 4 more
Source: ClinicalTrials.gov public record
Updated Oct 21, 2025 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 4 Interventional Results available

Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol

NCT00145574
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
colesevelam HCl, placebo
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
10 Years to 17 Years
Enrollment
194 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2007
U.S. locations
8
States / cities
Washington D.C., District of Columbia • St Louis, Missouri • New Hyde Park, New York + 5 more
Source: ClinicalTrials.gov public record
Updated Apr 15, 2010 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

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

NCT01122108
View directory record Official record
Conditions
Healthy
Interventions
Cholestyramine, Colesevelam HCl
Drug
Lead sponsor
Louisville Metabolic and Atherosclerosis Research Center
Other
Eligibility
18 Years to 70 Years
Enrollment
42 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010
U.S. locations
1
States / cities
Louisville, Kentucky
Source: ClinicalTrials.gov public record
Updated Oct 7, 2010 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 4 Interventional

Colesevelam Treatment for Impaired Fasting Glucose During Niacin Therapy

NCT01239004
View directory record Official record
Conditions
Dyslipidemia, Hyperlipidemia, Hyperglycemia
Interventions
Placebo, Colesevelam
Drug
Lead sponsor
Radiant Research
Other
Eligibility
18 Years and older
Enrollment
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
4
States / cities
Chicago, Illinois • Kansas City, Kansas • Minneapolis, Minnesota + 1 more
Source: ClinicalTrials.gov public record
Updated Jan 6, 2012 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 2 Interventional Results available

Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes

NCT00147745
View directory record Official record
Conditions
Type 2 Diabetes
Interventions
Colesevelam, Colesevelam matching placebo, Insulin glargine (Lantus)
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
18 Years to 75 Years
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2008
U.S. locations
1
States / cities
San Diego, California
Source: ClinicalTrials.gov public record
Updated Apr 2, 2014 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 2 Interventional Results available

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

NCT03270085
View directory record Official record
Conditions
Chronic Diarrhea, Irritable Bowel Syndrome With Diarrhea, Bile Acid Malabsorption
Interventions
Colesevelam, Placebo
Drug · Other
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years to 75 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Apr 27, 2020 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 4 Interventional Results available

Evaluate Carotid Artery Plaque Composition by Magnetic Resonance Imaging in People Receiving Cholesterol Medication

NCT00715273
View directory record Official record
Conditions
Coronary Artery Disease, Carotid Artery Diseases, Atherosclerosis
Interventions
Atorvastatin, Niacin, Colesevelam, Placebo Niacin, Placebo Colesevelam
Drug
Lead sponsor
University of Washington
Other
Eligibility
21 Years to 70 Years
Enrollment
217 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2019
U.S. locations
4
States / cities
Los Angeles, California • Boise, Idaho • Seattle, Washington + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 7, 2022 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 3 Interventional

WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes

NCT00147758
View directory record Official record
Conditions
Type 2 Diabetes
Interventions
Colesevelam hydrochloride
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
18 Years to 75 Years
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2006
U.S. locations
45
States / cities
Birmingham, Alabama • Tuscumbia, Alabama • Little Rock, Arkansas + 42 more
Source: ClinicalTrials.gov public record
Updated Jan 18, 2012 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Efficacy of Colesevelam in Subjects With Type 1 Diabetes Mellitus

NCT00938405
View directory record Official record
Conditions
Diabetes Mellitus, Type 1, Hyperlipidemias
Interventions
Colesevelam HCl, Placebo
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years to 65 Years
Enrollment
45 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated May 20, 2014 · Synced Oct 30, 2026, 7:01 AM EDT
Not yet recruiting Phase 2 Interventional Accepts healthy volunteers

Use of Bile Acid Binding Resins to Decrease PFAS Levels Via Colesevalem in Veterans Study

NCT07592858
View directory record Official record
Conditions
PFAS, Environmental Exposures, Occupational Exposure to Chemicals, Military Exposure, Burn Pit Exposure, Forever Chemicals, Hyperlipidemias, Hypercholesterolemia, Mixed Dyslipidemia, Hyperlipidemia (E.G., Hypercholesterolemia)
Interventions
Colesevelam, Placebo
Drug
Lead sponsor
University of Rhode Island
Other
Eligibility
25 Years to 65 Years
Enrollment
50 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2029
U.S. locations
2
States / cities
Louisville, Kentucky • Augusta, Maine
Source: ClinicalTrials.gov public record
Updated May 18, 2026 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Not applicable Interventional Results available

Mechanisms of Glucose Lowering Effect of Colesevelam HCl

NCT00596427
View directory record Official record
Conditions
Diabetes
Interventions
Colesevelam HCL, Placebo
Drug
Lead sponsor
Carine Beysen
Industry
Eligibility
30 Years to 70 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2009
U.S. locations
3
States / cities
Walnut Creek, California • Miami, Florida • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Oct 12, 2012 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 3 Interventional Results available

Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus

NCT00789750
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Colesevelam, Placebo, Pioglitazone
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
18 Years and older
Enrollment
562 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2012
U.S. locations
141
States / cities
Birmingham, Alabama • Montgomery, Alabama • Green Valley, Arizona + 114 more
Source: ClinicalTrials.gov public record
Updated Jun 26, 2017 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 3 Interventional Results available

A Study of Colesevelam in Fecal Incontinence

NCT02628626
View directory record Official record
Conditions
Fecal Incontinence, Bile Acid Malabsorption
Interventions
Colesevelam, Clonidine, Placebo
Drug · Other
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years to 80 Years · Female only
Enrollment
88 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2022
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Jun 22, 2023 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 4 Interventional

A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Atorvastatin for at Least 4 Weeks.

NCT00754507
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
colesevelam HCl tablets, and atorvastatin tablets, colesevelam HCl placebo tablets and atorvastatin tablets
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
18 Years and older
Enrollment
65 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2005
U.S. locations
13
States / cities
Los Angeles, California • Castle Rock, Colorado • Jacksonville, Florida + 10 more
Source: ClinicalTrials.gov public record
Updated Apr 3, 2015 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 2 Interventional Results available

Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

NCT01066364
View directory record Official record
Conditions
Nonalcoholic Steatohepatitis
Interventions
Colesevelam Hcl
Drug
Lead sponsor
University of California, San Diego
Other
Eligibility
18 Years and older
Enrollment
59 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
2
States / cities
La Jolla, California • San Diego, California
Source: ClinicalTrials.gov public record
Updated Jul 21, 2020 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 4 Interventional

A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Pravastatin for at Least 4 Weeks.

NCT00755352
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
pravastatin tablets and Welchol tablets, pravastatin tablets and Welchol placebo tablets
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
18 Years and older
Enrollment
67 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2005
U.S. locations
15
States / cities
Los Angeles, California • Castle Rock, Colorado • Jacksonville, Florida + 12 more
Source: ClinicalTrials.gov public record
Updated Apr 3, 2015 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 4 Interventional

Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol

NCT00754039
View directory record Official record
Conditions
Hypercholesterolemia, Hyperlipidemia, Familial Combined
Interventions
colesevelam HCl tablets and fenofibrate tablets, fenofibrate tablets and Welchol placebo tablets
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
30 Years to 70 Years
Enrollment
129 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2004
U.S. locations
10
States / cities
Longwood, Florida • Ocala, Florida • Winterpark, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Apr 3, 2015 · Synced Oct 30, 2026, 7:01 AM EDT
Completed Phase 4 Interventional Results available

Colesevelam for Children With Type 2 Diabetes

NCT01258075
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
High-dose colesevelam, Low-dose colesevelam
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
10 Years to 17 Years
Enrollment
236 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2020
U.S. locations
24
States / cities
Tucson, Arizona • Little Rock, Arkansas • Los Angeles, California + 20 more
Source: ClinicalTrials.gov public record
Updated May 13, 2021 · Synced Oct 30, 2026, 7:01 AM EDT