Colesevelam Hydrochloride

Hyperlipidemia, Physical Activity, Type 2 Diabetes + 3 more
Treatment
2 FDA approvals
20 Active Studies for Colesevelam Hydrochloride

What is Colesevelam Hydrochloride

ColesevelamThe Generic name of this drug
Treatment SummaryColesevelam is a medication used to lower cholesterol levels in the blood. It works by binding to bile acids in the intestine and preventing them from being absorbed into the bloodstream. To help achieve the best results, Colesevelam should be taken in conjunction with a diet that restricts cholesterol and fat intake.
Welcholis the brand name
image of different drug pills on a surface
Colesevelam Hydrochloride Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Welchol
Colesevelam
2000
42

Approved as Treatment by the FDA

Colesevelam, commonly known as Welchol, is approved by the FDA for 2 uses including Hyperlipidemia and High Cholesterol .
Hyperlipidemia
Used to treat Hyperlipidemias in combination with null
High Cholesterol
Used to treat Hyperlipidemias in combination with null

Effectiveness

How Colesevelam Hydrochloride Affects PatientsColesevelam is a medication that helps to lower cholesterol levels by binding to bile acids in the intestine. Studies have shown that having high levels of total cholesterol, LDL cholesterol, and apolipoprotein B (Apo B) is linked to an increased risk of atherosclerosis. On the other hand, low levels of HDL cholesterol can lead to the development of atherosclerosis. Taking colesevelam in combination with another cholesterol-lowering medication can further reduce levels of total cholesterol and LDL cholesterol beyond what either medication can do on its own.
How Colesevelam Hydrochloride works in the bodyColesevelam binds to bile acids in the intestine, preventing them from being reabsorbed. Instead, it causes the body to produce more cholesterol, which is then cleared from the bloodstream. This process lowers LDL cholesterol levels, while triglyceride levels may stay the same or even increase. The end result is a decrease in LDL cholesterol in the bloodstream.

When to interrupt dosage

The measure of Colesevelam Hydrochloride is contingent upon the identified illness, such as Type 2 Diabetes, Hypercholesterolemia and Hyperlipidemia. The dosage amount is contingent upon the technique of delivery as specified in the table below.
Condition
Dosage
Administration
Physical Activity
3750.0 mg, , 625.0 mg, 1875.0 mg
, Oral, For suspension, For suspension - Oral, Tablet, film coated, Tablet, film coated - Oral, Powder, for suspension, Powder, for suspension - Oral, Tablet, Tablet - Oral, Tablet, coated, Tablet, coated - Oral, Bar, chewable, Bar, chewable - Oral
Type 2 Diabetes
3750.0 mg, , 625.0 mg, 1875.0 mg
, Oral, For suspension, For suspension - Oral, Tablet, film coated, Tablet, film coated - Oral, Powder, for suspension, Powder, for suspension - Oral, Tablet, Tablet - Oral, Tablet, coated, Tablet, coated - Oral, Bar, chewable, Bar, chewable - Oral
High Cholesterol
3750.0 mg, , 625.0 mg, 1875.0 mg
, Oral, For suspension, For suspension - Oral, Tablet, film coated, Tablet, film coated - Oral, Powder, for suspension, Powder, for suspension - Oral, Tablet, Tablet - Oral, Tablet, coated, Tablet, coated - Oral, Bar, chewable, Bar, chewable - Oral
Diet
3750.0 mg, , 625.0 mg, 1875.0 mg
, Oral, For suspension, For suspension - Oral, Tablet, film coated, Tablet, film coated - Oral, Powder, for suspension, Powder, for suspension - Oral, Tablet, Tablet - Oral, Tablet, coated, Tablet, coated - Oral, Bar, chewable, Bar, chewable - Oral
Hypercholesterolemia
3750.0 mg, , 625.0 mg, 1875.0 mg
, Oral, For suspension, For suspension - Oral, Tablet, film coated, Tablet, film coated - Oral, Powder, for suspension, Powder, for suspension - Oral, Tablet, Tablet - Oral, Tablet, coated, Tablet, coated - Oral, Bar, chewable, Bar, chewable - Oral
Hyperlipidemia
3750.0 mg, , 625.0 mg, 1875.0 mg
, Oral, For suspension, For suspension - Oral, Tablet, film coated, Tablet, film coated - Oral, Powder, for suspension, Powder, for suspension - Oral, Tablet, Tablet - Oral, Tablet, coated, Tablet, coated - Oral, Bar, chewable, Bar, chewable - Oral

Warnings

There are 20 known major drug interactions with Colesevelam Hydrochloride.
Common Colesevelam Hydrochloride Drug Interactions
Drug Name
Risk Level
Description
Mycophenolate mofetil
Major
Colesevelam can cause a decrease in the absorption of Mycophenolate mofetil resulting in a reduced serum concentration and potentially a decrease in efficacy.
Mycophenolic acid
Major
Colesevelam can cause a decrease in the absorption of Mycophenolic acid resulting in a reduced serum concentration and potentially a decrease in efficacy.
Raloxifene
Major
Colesevelam can cause a decrease in the absorption of Raloxifene resulting in a reduced serum concentration and potentially a decrease in efficacy.
(R)-warfarin
Minor
Colesevelam can cause a decrease in the absorption of (R)-warfarin resulting in a reduced serum concentration and potentially a decrease in efficacy.
(S)-Warfarin
Minor
Colesevelam can cause a decrease in the absorption of (S)-Warfarin resulting in a reduced serum concentration and potentially a decrease in efficacy.
Colesevelam Hydrochloride Toxicity & Overdose RiskTaking too much colesevelam may cause eye irritation, constipation, abdominal cramps, nausea, vomiting, and/or diarrhea. It is unlikely to cause serious systemic toxicity, since it does not get absorbed into the body. Taking more than 4.5 grams per day has not been tested.
image of a doctor in a lab doing drug, clinical research

Colesevelam Hydrochloride Novel Uses: Which Conditions Have a Clinical Trial Featuring Colesevelam Hydrochloride?

184 active studies are assessing the potential of Colesevelam Hydrochloride for treating Hyperlipidemia, Type 2 Diabetes and Hypercholesterolemia.
Condition
Clinical Trials
Trial Phases
Hyperlipidemia
0 Actively Recruiting
High Cholesterol
17 Actively Recruiting
Phase 2, Phase 3, Not Applicable, Early Phase 1
Diet
5 Actively Recruiting
Not Applicable, Phase 1
Physical Activity
24 Actively Recruiting
Not Applicable, Phase 1, Phase 2
Hypercholesterolemia
4 Actively Recruiting
Phase 1, Phase 3
Type 2 Diabetes
168 Actively Recruiting
Not Applicable, Phase 1, Phase 2, Phase 3, Phase 4, Early Phase 1

Colesevelam Hydrochloride Reviews: What are patients saying about Colesevelam Hydrochloride?

4.3Patient Review
8/16/2010
Colesevelam Hydrochloride for Additional Medication for Diabetes Type 2
4Patient Review
10/21/2010
Colesevelam Hydrochloride for High Cholesterol
So far, this has been working well for me. I've taken it orally before and had to stop because of heat-related issues; however, the replacement medications all had such terrible side effects that I asked to be put back on this one.
4Patient Review
4/8/2022
Colesevelam Hydrochloride for Heterozygous Inherited High Blood Cholesterol
I've been on this cholesterol medication for decades, and it's helped reduce my LDL by about 25%. It works in the digestive tract to remove fats without entering the bloodstream. I use the powder form because the pills are so large, which dissolves well if you use a shaker cup. I find that adding cherry juice helps with the taste.
4Patient Review
4/28/2020
Colesevelam Hydrochloride for High Cholesterol
I've been using this product for a few years now and have generally been pleased. However, the recent change in manufacturers has resulted in a thinner, stickier product that I'm not as fond of. I contacted the Federal Drug Administration about it.
3.7Patient Review
2/10/2011
Colesevelam Hydrochloride for High Cholesterol
I've found that this medication prevents my body from absorbing levothyroxine, which is something most doctors are unaware of. I'm currently taking the levothyroxine four hours before the first dose of welchol to see how it works.
3.3Patient Review
7/28/2022
Colesevelam Hydrochloride for High Cholesterol
I can use Colesevelam for a few weeks before I start to experience negative side effects like depression and insomnia. Once I stop taking the medication, those problems go away too.
1Patient Review
1/13/2013
Colesevelam Hydrochloride for High Cholesterol
I took the first three pills and then one hour later had a severe headache (migraine), light sensitivity, and extreme abdominal bloating. I also had a severe hemmroidal flare up with constipation and rectal bleeding. Dizziness made it all worse. It took me three days to recover from these effects, and this was only after taking half of the recommended dose.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about colesevelam hydrochloride

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is colesevelam hydrochloride used to treat?

"Colesevelam is a medication used to lower high cholesterol and blood sugar levels. It is often used in conjunction with diet and exercise to prevent medical problems associated with high cholesterol and blood sugar levels."

Answered by AI

What are side effects of colesevelam?

"What are the side effects of gas-x? They can include constipation, nausea, vomiting, diarrhea, heartburn, stomach or back pain, and headaches."

Answered by AI

Is colesevelam HCl a statin?

"Welchol is a drug that lowers bad cholesterol in a different way from statins. Statins work in the liver, while Welchol works in the intestines. Welchol is a "bile acid sequestrant" that is indicated to lower LDL or "bad" cholesterol."

Answered by AI

Does colesevelam stop diarrhea?

"In a 2009 study, 45 people with cancer and symptoms of bile acid malabsorption were given colesevelam. After 3 months, they experienced improvements in diarrhea, frequency and urgency of defecation, steatorrhoea, abdominal pain, and faecal incontinence."

Answered by AI

Clinical Trials for Colesevelam Hydrochloride

Image of KPNC Division of Research in Pleasanton, United States.

MetSense Risk Flag for Type 2 Diabetes

18+
All Sexes
Pleasanton, CA
People with serious mental illness have high risk for type 2 diabetes due to multiple risk factors, including the metabolic side effects of psychotropic medications that are used to treat these conditions. Type 2 diabetes is preventable through lifestyle and pharmacological interventions, but many people with serious mental illness do not receive regular screening for type 2 diabetes risk. In many health care settings, clinical pharmacists are increasingly managing patients with serious mental illness and have expertise in monitoring the metabolic side effects of psychotropic medications. This study evaluates the feasibility and acceptability of using a diabetes prediction model that is based on electronic health record data (the MetSense risk flag) to alert clinical pharmacists about patients who are at high diabetes risk, prompting these clinicians to prioritize diabetes risk management services.
Waitlist Available
Has No Placebo
KPNC Division of ResearchEsti Iturralde, PhD
Image of University of California, Los Angeles in Los Angeles, United States.

Tailored DPP for Prediabetes

17 - 25
All Sexes
Los Angeles, CA
The goal of this study is to enhance reach and uptake of diabetes prevention among young adults, with a focus on recruiting underserved and high-need students who face additional challenges, including food and financial insecurity. The specific aims are: Aim 1 - Evaluate the efficacy of an AYA-tailored version of the UC DPP for mitigating type 2 diabetes risk (i.e., weight change) in a pre/post pilot trial. The investigators hypothesize that the AYA-tailored intervention will be effective at producing 5% weight loss from baseline to program completion (at 9-months). Aim 2 - Assess the feasibility and acceptability of an AYA-tailored version of the UC DPP program. The investigators hypothesize that it will be feasible to recruit the desired number of participants given proposed innovative outreach strategies, and that the AYA-tailored intervention will be deemed acceptable to participants both qualitatively and in regards to their retention in the program at rates similar to the larger UC DPP. The investigators will recruit 80 UCLA undergraduate students. Participants will be asked to complete a brief screening online form to assess eligibility and to collect contact information. The PI and/or Research Assistants (RAs) will reach out to eligible participants to obtain informed consent and enroll them in the pilot trial. The investigators will randomize participants to the tailored DPP cohort vs control cohort. Control participants will be offered the opportunity to participate in the tailored DPP in the following academic year. The tailored DPP intervention will be online and asynchronously. Participants will be asked to complete the intervention lessons on their own time. Each lesson typically takes on average 15 minutes to complete. Control group will receive each intervention materials via e-mail for participants to review on their own time and will receive acceptability surveys. The interventions for the control group will be remote. A research assistant will meet with control participants via Zoom to explain the intervention materials. Control group will receive access to a study habits intervention, alcohol use intervention, and financial literacy intervention. At the end of each quarter (Fall, Winter, and Spring), both control and intervention participants will receive an email with a unique link to a brief REDCap survey to ascertain acceptability of sessions/lessons. Furthermore, participants will complete baseline and 9-month follow-up assessments. Participants will complete a 30 minute questionnaire and height/weight measurements will be collected by a RA. Participants will be asked to self-report weight and physical activity at the end of the fall and winter quarter; data will be collected via brief REDCap survey.
Recruiting
Has No Placebo
University of California, Los AngelesLauren E Wisk, PhD
Have you considered Colesevelam Hydrochloride clinical trials? We made a collection of clinical trials featuring Colesevelam Hydrochloride, we think they might fit your search criteria.Go to Trials
Image of Medpace Clinical Pharmaology Unit in Cincinnati, United States.

PATAS for Type 2 Diabetes

18 - 55
All Sexes
Cincinnati, OH
The primary objective of Part 1 of this study is to evaluate safety and tolerability of single subcutaneous (SC) doses of PATAS in healthy subjects. The secondary objective of Part 1 of this study is to determine the pharmacokinetics (PK) of single SC doses of PATAS in healthy subjects. The primary objectives of Part 2 of this study are to evaluate the safety and tolerability of 4 weekly SC doses of PATAS in subjects with T2D; and to determine the PK and pharmacodynamics (PD) of 4 weekly SC doses of PATAS in subjects with T2D. The secondary objectives of Part 2 of this study are to evaluate the potential effect of multiple SC doses of PATAS on markers of glycemic control, as measured by glucose levels, insulin levels, and other metabolomic biomarkers; and to characterize the adverse event (AE) profiles of the various dose levels of PATAS.
Phase 1
Waitlist Available
Medpace Clinical Pharmaology UnitVincent Marion, Ph.D.AdipoPharma LLC
Image of The Worship Center Cristian Church in Birmingham, United States.

Black Impact for Heart Health

18+
Male
Birmingham, AL
The goal of this clinical trial is to evaluate the implementation and effectiveness of the Black Impact program-a church-based cardiovascular health (CVH) intervention-in Black men aged 35-70 who are at risk for heart disease, diabetes, obesity, and related conditions. The main questions this study aims to answer are: * Does participation in the Black Impact program improve cardiovascular health metrics (e.g., blood pressure, cholesterol, blood sugar) and health behaviors among Black men at The Worship Center Christian Church (TWC)? * What factors influence the adoption, delivery, and sustainability of the Black Impact program in a faith-based setting? Researchers will compare an immediate-start intervention group and a delayed-start (waitlist control) group to assess both short-term health outcomes and program implementation factors. Participants will: * Attend a 90-minute weekly session for 24 weeks, including 45 minutes of physical activity led by a certified trainer and 45 minutes of health education delivered by trained coaches. * Receive one-on-one support from a community health worker to reduce barriers to care and engage with primary care. * Complete biometric health screenings and surveys at baseline, 12 weeks, and 24 weeks to assess clinical and behavioral outcomes. * Use a smartwatch, blood pressure cuff, and other tools to track progress in real time. * Participate in exit focus groups or interviews to share feedback about the intervention. * A subset of TWC leaders and interventionists (N=15) will also be interviewed to assess implementation, resource needs, and sustainability. This study uses the RE-AIM framework to assess Reach, Effectiveness, Adoption, Implementation, and Maintenance, and aims to inform scalable strategies for improving CVH among Black men in trusted community settings.
Waitlist Available
Has No Placebo
The Worship Center Cristian Church
Have you considered Colesevelam Hydrochloride clinical trials? We made a collection of clinical trials featuring Colesevelam Hydrochloride, we think they might fit your search criteria.Go to Trials
Image of University of British Columbia - Okanagan in Kelowna, Canada.

Estrogen and Testosterone for Gender Differences in Physiology

18 - 40
All Sexes
Kelowna, Canada
Due to historical exclusion of females from research, there are gaps in the understanding of female physiology, how it differs from males, and how sex-specific hormones contribute. As a result, many diagnoses and treatments are based on male physiology and may not be appropriate or effective for females. Females consistently experience greater risk and report worse neurological outcomes in many diseases, including stroke, cardiac arrest, and dementia. As research in females progresses, differences between sexes and changes throughout the lifespan (e.g., puberty, menopause) highlight the importance of understanding the effects of sex and sex-specific hormones on the body. The brain is arguably the most important organ in the body, consuming 20% of the body's total energy. Previous research supports higher blood flow to the brain in females, and research in animals suggests hormones such as estrogen, progesterone, and testosterone are responsible. However, it is extremely difficult to isolate these hormones in humans, due to natural fluctuations (i.e., menstrual cycle). Therefore, the investigators plan to explore the direct role of these sex-specific hormones in regulating blood flow to the brain by blocking hormone production in healthy males and females and giving back testosterone and estrogen, respectively. The investigators will then conduct a range of tests to look at blood flow to the brain at rest and during various stressors. This research will provide crucial insight into how males and females differ in regulation of brain blood flow and inform new treatments and therapies to a wide range of brain injuries and diseases, improving outcomes and reducing the sex disparity in clinical pathways.
Waitlist Available
Has No Placebo
University of British Columbia - OkanaganPhilip Ainslie, PhD
Have you considered Colesevelam Hydrochloride clinical trials? We made a collection of clinical trials featuring Colesevelam Hydrochloride, we think they might fit your search criteria.Go to Trials
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