Colesevelam Hydrochloride

Hyperlipidemia, Physical Activity, Type 2 Diabetes + 3 more

Treatment

2 FDA approvals

20 Active Studies for Colesevelam Hydrochloride

What is Colesevelam Hydrochloride

Colesevelam

The Generic name of this drug

Treatment Summary

Colesevelam 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.

Welchol

is 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 Patients

Colesevelam 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 body

Colesevelam 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 - Oral, Bar, chewable

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 - Oral, Bar, chewable

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 - Oral, Bar, chewable

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 - Oral, Bar, chewable

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 - Oral, Bar, chewable

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 - Oral, Bar, chewable

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 Risk

Taking 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

18 Actively Recruiting

Phase 2, Phase 3, Early Phase 1, Not Applicable

Diet

4 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

157 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?

4.3

Patient Review

8/16/2010

Colesevelam Hydrochloride for Additional Medication for Diabetes Type 2

4

Patient 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.

4

Patient 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.

4

Patient 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.

3.7

Patient 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.

3.3

Patient 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.

1

Patient 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 Centre EPIC in Montreal, Canada.

Maple Syrup for Endurance Cycling Performance

18 - 45
Male
Montreal, Canada

The goal of this clinical trial is to learn whether maple syrup can be used as a natural carbohydrate source to help trained male cyclists perform better during long-duration cycling. The study also aims to learn how different amounts of maple syrup affect energy use in the body, stomach comfort, and feelings of effort and fatigue. The main questions the study aims to answer are: * Does consuming more carbohydrate from maple syrup help participants finish a 20-kilometer cycling time trial faster? * How do different amounts of maple syrup change how the body uses carbohydrates and fats during long exercise? * Are higher amounts of maple syrup easy for participants to tolerate without stomach problems? Researchers will compare four drinks: 1. A placebo drink (a look-alike drink with no calories), 2. A drink that provides 60 grams of carbohydrate per hour, 3. A drink that provides 90 grams per hour, and 4. A drink that provides 120 grams per hour. They will compare these drinks to see whether higher carbohydrate amounts lead to better cycling performance and how each dose affects comfort and metabolism. Participants will: * Attend a screening visit that includes a health check and a glucose tolerance test. * Complete a fitness test to measure their aerobic capacity and practice the cycling tests used in the study. * Take part in four separate exercise sessions in random order. Each session includes: * Drinking one of the four study beverages during 2 hours of steady cycling, * Completing two short, all-out 6-second sprints during the ride, * Completing a 20-kilometer cycling time trial as fast as possible, * Reporting stomach symptoms and perceptions of effort, * Providing breath, blood, urine, and sweat samples so researchers can measure how their body uses fuel. All drinks will look, taste, and smell similar so participants cannot tell which one they are receiving. Meals before each session will be provided to keep conditions the same across visits. This study may help athletes and active people choose natural carbohydrate sources that support both performance and comfort during long endurance exercise. The findings may also guide future research on the use of maple syrup as a sports nutrition option.

Waitlist Available
Paid Trial

Centre EPIC

Jonathan Tremblay, PhD

Mitacs

Image of National Association of Pasifika Organizations in Fayetteville, United States.

PILI Pasifika Program for Cardiometabolic Conditions

18+
All Sexes
Fayetteville, AR

In this study, the investigators are testing the effectiveness and implementation of the Community Health Workers (CHW)-delivered PILI Pasifika Program (PPP) Standard Facilitation or Enhanced Facilitation across 3 regions, the U.S. Affiliated Pacific Islands (USAPI), the continental U.S., and Hawai'i, among 600 Native Hawaiian and Pacific Islander (NHPI) participants in two settings, (clinical and non-clinical) over a 3-year period. The PPP is a 3-month lifestyle intervention that includes a Social Determinants of Health (SDOH) component and was NHPI-adapted from the Diabetes Prevention Program's Lifestyle Program, renamed to the PILI Lifestyle Program (PLP), which demonstrated effectiveness in improving weight, blood pressure, physical activity, and diet among NHPIs. The PPP consists of 8 lifestyle lessons and 4 SDOH activities delivered over a 3-month period. The investigators will conduct an effectiveness-implementation hybrid type 2 trial using a 3 (Region) x 2 (Setting) x 2 (Delivery Mode) factorial design. The long-term objective of this study is threefold: 1. To conduct an effectiveness-implementation hybrid 2 trial to test the effects of the PPP implementation strategies across different settings and modes of delivery among 600 NHPIs at risk for cardiometabolic-related conditions using an NHPI-approved and adapted evaluation framework. The investigators will also assess and compare the cost-effectiveness of the CHW-delivered PPP-Standard Facilitation and PPP-Enhanced Facilitation to support long-term sustainability. 2. To conduct a longitudinal Social Determinants of Health (SDOH) survey embedded within the trial to examine the reliability and validity of indices from 5 adapted SDOH instruments and to assess the associations between SDOH variables and chronic disease risk among NHPIs. 3. To implement and evaluate the contextually-based CHW training program on PPP delivery.

Waitlist Available
Has No Placebo

National Association of Pasifika Organizations (+1 Sites)

Joseph K Kaholokula, PhD

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Saskatoon Berries for Type 2 Diabetes

18 - 74
All Sexes
Winnipeg, Canada

Diabetes becomes epidemic in worldwide countries. Diabetes Canada indicated that 30% of adults in Manitoba are diabetes or prediabetes. Nine out of ten diabetic patients are type 2 diabetes (T2D). T2D is characterized by insulin resistance and obesity. Uncontrolled diabetes leads to serious consequences including heart attack, stroke, chronic renal failure, liver failure, blindness and low limb amputation. Most of hypoglycemic medications have certain side effects. Natural foods or nutraceuticals with hypoglycemic potential are expected to provide a safer management for diabetic patients. Saskatoon berry is a popular fruit in Canadian Prairie and Northern states in USA. Previous studies in the investigator's group demonstrated Saskatoon berry (SB) powder attenuated hyperglycemia, hyperlipidemia, insulin resistance, inflammation, liver steatosis and gut dysbiosis in diet-induced insulin resistant mice, a model for T2D. The findings of the glucose and lipid lowering or liver protective effects of SB powder have been supported by another group in Australia in high fat fed rats. Preliminary studies by the investigators in 20 healthy subjects demonstrated that dried whole SB (40 g/day for 10 weeks) significantly reduced fasting plasma glucose, total and LDL-cholesterol, systolic blood pressure, and increased plasma glucagon-like peptide compared to baseline, which was associated with increased intake of total fiber and decreased intake of saturated fat. The changes in metabolic and vascular variables significantly correlated with the alterations in gut microbiota The combination of findings suggest that SB is good candidate of prebiotic functional food as a supplemental remedy for reducing the risk for metabolic syndrome and preventing or managing T2D. The effect of Saskatoon berry and its products on metabolic disorders have not been studied in diabetic subjects. The investigators propose to examine the effects of oral administration of freeze-dried whole SB on glucose metabolism, insulin resistance and gut microbiota in untreated prediabetes and new type 2 diabetic patients compared to a control dried fruit in a randomized controlled trial.

Waitlist Available
Dietary Supplement

Faculty of Health Sciences

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CX11 for Type 2 Diabetes

18 - 75
All Sexes
Birmingham, AL

This study is testing whether a new medication called CX11 works and is safe for participants with type 2 diabetes who have not reached good blood sugar control while taking a steady dose of metformin, with or without a steady dose of an SGLT2 inhibitor, for at least 90 days. The study is being done at multiple medical centers. Participants are assigned by chance (randomized) to different groups, and neither the participants nor the study staff know which group they're in (double-blind). The groups are compared side by side (parallel), and some participants will receive inactive pills (placebo) to help measure the true effect of the study drug. After screening, participants will be randomly placed into one of six groups, with equal chances of being in any group. Each group will receive a different dose of CX11 or a placebo. Treatment will last 24 weeks. After that, all participants will have a 2-week follow-up period to check on safety.

Phase 2
Waitlist Available

Central Research Associates - Flourish - PPDS (+29 Sites)

Corxel Pharmaceuticals

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Pharmacist-led Care for Diabetes

18+
All Sexes
Edmonton, Canada

As of 2024, nine percent of Albertans are living with Type 2 diabetes, which increases their risk for cardiovascular disease, stroke, blindness, and kidney failure. Unfortunately, less than half of patients have controlled Type 2 diabetes. We are well aware of the factors which lead to worsening diabetes, but need to give people more support to help them manage their diabetes. Pharmacists are respected health care professionals who are often easier to see that doctors and can help people with diabetes to stay as healthy as possible. This research project aims to see whether a pharmacist service can help improve diabetes management in people with type 2 diabetes compared to usual care from their family physician or nurse practitionner. The potential impact of this project is to empower people with type 2 diabetes to understand their condition, it's management, and to achieve target blood sugar levels, which will ultimately reduce the risk of diabetes-related complications.

Recruiting
Has No Placebo

University of Alberta

Ross Tsuyuki, BScPharm, PharmD, MSc

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Adaptive Dietary Intervention for Type 2 Diabetes

18+
All Sexes
New York, NY

The investigators will examine the feasibility, acceptability, and effect of an adaptive dietary intervention over 24 weeks (12-week intervention, 12-week follow-up) among Asian Americans with Type 2 diabetes. Participants (N=120; 60 Chinese Americans and 60 Vietnamese Americans) will be 2:1 randomized to one of two arms: adaptive dietary intervention or standard of care (SC). The intervention will begin with continued glucose monitoring (CGM) use only during weeks 0-4. At week 4, participants who achieve the glycemic control goal (at least an 8% increase in time in range \[TIR\] from baseline) will continue with the CGM alone during weeks 4-12 ("CGM Alone"); otherwise, culturally and linguistically adapted glucose excursion minimization (GEM) will be augmented with CGM ("CGM-GEM").

Waitlist Available
Has No Placebo

NYU Langone Health

Yaguang Zheng, PhD, RN

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