Xenical

Obesity, Caloric Restriction, Obesity + 2 more

Treatment

20 Active Studies for Xenical

What is Xenical

Orlistat

The Generic name of this drug

Treatment Summary

Orlistat is a medication used to treat obesity. It works by blocking the body’s absorption of fat from food. It was approved by the FDA in 1999 and can be obtained over-the-counter or by prescription, depending on the dose. Orlistat is generally a safe and effective weight loss aid and is used in combination with a reduced-calorie diet.

Alli

is the brand name

image of different drug pills on a surface

Xenical Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Alli

Orlistat

2007

6

Effectiveness

How Xenical Affects Patients

Orlistat helps people lose and maintain weight by preventing the body from absorbing dietary fats. It does this by blocking the enzymes (lipase) that help break down fats.

How Xenical works in the body

Orlistat is a drug that blocks the digestion of fat. It works by binding to the enzymes in the stomach and intestines that break down fat molecules. When orlistat is taken with food, it prevents some of the fat from being absorbed by the body, which can lead to weight loss.

When to interrupt dosage

The recommended dosage of Xenical is contingent upon the determined condition, like Weight Reduction, Unintentional Weight Loss and Obesity. The quantity of dosage fluctuates based on the procedure of delivery delineated in the table below.

Condition

Dosage

Administration

Weight Loss

, 120.0 mg, 27.0 mg, 60.0 mg

, Oral, Capsule - Oral, Capsule, Tablet, chewable, Tablet, chewable - Oral

Obesity

, 120.0 mg, 27.0 mg, 60.0 mg

, Oral, Capsule - Oral, Capsule, Tablet, chewable, Tablet, chewable - Oral

Caloric Restriction

, 120.0 mg, 27.0 mg, 60.0 mg

, Oral, Capsule - Oral, Capsule, Tablet, chewable, Tablet, chewable - Oral

Obesity

, 120.0 mg, 27.0 mg, 60.0 mg

, Oral, Capsule - Oral, Capsule, Tablet, chewable, Tablet, chewable - Oral

Obesity

, 120.0 mg, 27.0 mg, 60.0 mg

, Oral, Capsule - Oral, Capsule, Tablet, chewable, Tablet, chewable - Oral

Warnings

Xenical has six contraindications and should not be administered in unison with the conditions provided in the following table.

Xenical Contraindications

Condition

Risk Level

Notes

Malabsorption Syndrome

Do Not Combine

Pulse Frequency

Do Not Combine

Malabsorption

Do Not Combine

known hypersensitivity to the drug or any of the ingredients

Do Not Combine

Thinness

Do Not Combine

Cholestasis

Do Not Combine

There are 20 known major drug interactions with Xenical.

Common Xenical Drug Interactions

Drug Name

Risk Level

Description

Nifedipine

Minor

Orlistat can cause a decrease in the absorption of Nifedipine resulting in a reduced serum concentration and potentially a decrease in efficacy.

Propafenone

Minor

Orlistat can cause a decrease in the absorption of Propafenone resulting in a reduced serum concentration and potentially a decrease in efficacy.

(R)-warfarin

Moderate

Orlistat may increase the anticoagulant activities of (R)-warfarin.

(S)-Warfarin

Moderate

Orlistat may increase the anticoagulant activities of (S)-Warfarin.

1alpha,24S-Dihydroxyvitamin D2

Moderate

Orlistat can cause a decrease in the absorption of 1alpha,24S-Dihydroxyvitamin D2 resulting in a reduced serum concentration and potentially a decrease in efficacy.

Xenical Toxicity & Overdose Risk

The highest amount of orlistat which has been found to be toxic in rats is over 5000mg/kg. In studies, healthy and overweight people have taken 800mg single doses and up to 400mg three times a day for 15 days without any serious side effects. In addition, people who were obese were given 240mg three times a day for 6 months with little to no adverse effects. Reports of overdoses have also shown no significant adverse events or events similar to those reported with recommended doses. If someone takes a large overdose of orlistat, they should be monitored for at least 24 hours. Clinical studies have revealed that any systemic effects

image of a doctor in a lab doing drug, clinical research

Xenical Novel Uses: Which Conditions Have a Clinical Trial Featuring Xenical?

169 active clinical trials are assessing the potential of Xenical to reduce Weight, Disease and BMI >27 kg/m2.

Condition

Clinical Trials

Trial Phases

Caloric Restriction

0 Actively Recruiting

Obesity

14 Actively Recruiting

Not Applicable, Phase 2, Phase 3

Obesity

0 Actively Recruiting

Obesity

45 Actively Recruiting

Phase 2, Not Applicable, Phase 4, Phase 3, Phase 1

Weight Loss

0 Actively Recruiting

Xenical Reviews: What are patients saying about Xenical?

5

Patient Review

5/21/2016

Xenical for Overweight

No issues with the medication

5

Patient Review

8/18/2020

Xenical for Overweight

I've had great results from this treatment so far. I'm down six pounds in one week and haven't experienced any severe side effects.

4.3

Patient Review

7/15/2015

Xenical for Overweight

I used to take Xenical 120 mg in order to lose weight. I never experienced any negative side effects, which was great. I purchased the medicine from MedsMartDrugs. Now my stomach is almost flat and I can eat anything I want!

3.7

Patient Review

9/21/2015

Xenical for Overweight

HELP... I need help understanding what is going on... My clothes are fitting bigger but I have gained 10 pds this week,,, This is my first week and I have been on a very low fat low cal diet... What am I doing wrong... I have even rode my stationary bike three days... for thirty mins each day. I have been some what constipated... So any advise out there for me please help me....

3.7

Patient Review

9/17/2014

Xenical for Overweight

After consuming a fatty meal, I felt lightheaded and breathless about an hour later. Additionally, I needed to use the restroom frequently. Not sure if the benefits outweigh the negatives here.

3.3

Patient Review

1/16/2019

Xenical for Overweight

I'm really feeling the burn after only one day of this treatment!

3

Patient Review

3/21/2016

Xenical for Overweight

I've only been using this pill for a couple days, and I'm already noticing some itchy skin. Has anyone else experienced this? I have sensitive skin normally so I use special products in the shower and after, but it's still happening.

3

Patient Review

1/17/2019

Xenical for Overweight

I started taking this medication last night, and this morning I had an unfortunate side effect. After reading other reviews, I now know what to expect and how to deal with it.

2.7

Patient Review

7/12/2022

Xenical for Overweight

You definitely will learn quickly what foods to stay away from. I did lose weight at the expense of several severe oily stools and ruined clothing some at the most inopportune times.

2.7

Patient Review

9/23/2022

Xenical for Overweight

I haven't seen the results I was hoping for after nine weeks. In addition to weight fluctuations, I've also been dealing with a lot of intestinal cramping. Overall, not worth the money.

2.3

Patient Review

8/31/2014

Xenical for Overweight

I have tried using this product but have not seen any results.

2.3

Patient Review

7/9/2022

Xenical for Overweight

I didn't use this treatment for very long because it made me oily and I was constantly leaking. It was really unpleasant and not something that I could see myself continuing to use for more than a week or two.

1.7

Patient Review

6/21/2016

Xenical for Overweight

I used to love this drug because it was effective. Recently, however, I feel like the formula has changed because I no longer see any results. And based on what I've read online, I'm not the only one with this problem.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about xenical

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

What is the side effect of Xenical?

"If you have serious side effects from Xenical, tell your doctor. This can include blood in your urine, urinating less than usual or not at all, drowsiness, confusion, mood changes, increased thirst, swelling, weight gain, feeling short of breath, severe pain in your upper stomach spreading to your back, or fast heart rate."

Answered by AI

How fast will Xenical work?

"Xenical should be taken every day for it to be effective. People usually start seeing weight loss within 2 weeks, and it continues for 6 to 12 months. After that, Xenical will help you to maintain the new lower weight and prevent any weight regain."

Answered by AI

How much weight will I lose on Xenical?

"Combining Xenical with a healthy diet results in weight loss for 4 out of 10 people. People who use Xenical as part of their weight loss efforts are twice as likely to lose weight as those who don't use Xenical."

Answered by AI

Is Xenical good for weight loss?

"Xenical prevents some of the fat you eat from being absorbed by your body. It's used to aid weight loss or help prevent weight regain after weight loss. This medicine must be used with a reduced-calorie diet and is for use only by adults."

Answered by AI

Why was Xenical taken off the market?

"The FDA banned two pills, Fen-phen and ephedra, because of potentially fatal side effects. However, studies suggest that taking Xenical or Alli would only help people lose 4 to 6 pounds more than they would with diet and exercise alone."

Answered by AI

Clinical Trials for Xenical

Image of Mayo Clinic in Rochester, United States.

Weight Loss Medications for Obesity in Bipolar Disorder

18 - 65
All Sexes
Rochester, MN

The goal of this clinical trial is to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss, and to study the effect of individualized guided medication in patients with bipolar disorder ages 18-65. The main questions it aims to answer are: * Can the investigators compare the distribution of obesity characteristics (hungry brain, hungry gut, emotional hunger) between bipolar patients and non-bipolar participants (comparing from IRB #24-002375)? * Can the investigators evaluate the feasibility of anti-obesity medication (AOM) in patients with bipolar disorder? Participation will last for about 17-18 weeks and includes 7 in-person study visits, 4 phone call visits, and 12 virtual group therapy sessions. The first visit lasts about 2 hours and includes going over the informed consent form, a diagnostic interview to confirm diagnosis, gathering vital signs, mood questionnaires, an ECG, and urine drug and pregnancy tests (if applicable). The second visit lasts about 6-7 hours and involves multiple procedures and completing questionnaires to determine which study drug would allow participants to lose weight most effectively. At the third visit, participants will be assigned to take one of three FDA approved medications for weight loss: Semaglutide (Wegovy®), Naltrexone/Bupropion (Contrave®), or Phentermine/Topiramate (Qysmia®). It is possible that participants could be assigned to a group that receives no study medication. All participants will be enrolled in a 12-week virtual group therapy program targeted for weight loss. On this third visit the investigators will also gather vital signs, and participants will give a sample of blood. After the third visit, participants will come in for study visits every 4 weeks for 16 weeks (4 visits) to assess medication adherence, vitals, and answer questions about mood and eating (participants will also give a sample of blood at the 8-week and 16-week visits). Every two weeks in between in-person visits, the study team will call participants to assess medication adherence. Participants will be compensated for time spent in this study.

Phase 4
Waitlist Available

Mayo Clinic

Mark A Frye, M.D.

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Image of Stanford University School of Medicine in Palo Alto, United States.

Dietary Strategies for Obesity

18+
All Sexes
Palo Alto, CA

The goal of the Reset trial is to learn about the optimal combination of dietary behavior strategies in a fully digital weight loss intervention. The intervention is designed for adults with overweight or obesity. The investigators will examine the impact on weight loss of four dietary strategies: 1) limiting Red Zone Foods (i.e., foods that are high in calories and low in nutrition), 2) limiting eating windows, 3) increasing protein intake, and 4) increasing fiber intake. Each of these strategies will include goal setting, daily self-monitoring, and tailored feedback. The investigators will recruit 208 participants. Broadly, adults with overweight or obesity who live in the U.S. will be eligible. The weight loss intervention will last 12 weeks. All participants will be asked to track their body weight daily and complete weekly behavioral lessons and action plans to promote healthy eating and physical activity. All study tasks will occur remotely. Assessment of body weight and survey measures will occur at the beginning of the trial ("baseline"), and at 1 month and 3 months. The Multiphase Optimization Strategy (MOST) framework will be used to identify which combination of the dietary behavior strategies results in the greatest weight loss. In total, there will be 16 treatment conditions.

Waitlist Available
Has No Placebo

Stanford University School of Medicine

Michele L Patel, PhD

Image of University of South Florida in Tampa, United States.

TORe + Lifestyle Changes for Weight Regain

18+
All Sexes
Tampa, FL

The goal of this clinical trial is to evaluate weight loss with TORe and intensive lifestyle modification versus intensive lifestyle modification alone in subjects who have regained weight following a Roux-en-Y gastric bypass. Participants will randomized 2:1. Those randomized to the TORe arm will receive a TORe procedure and intensive lifestyle modification which consists of a well-balanced calorie restrictive diet, incorporation of exercise and coaching on lifestyle discussion. Participants randomized the lifestyle modification alone arm will be eligible to receive a TORe procedure at 6 months post enrollment. Total follow up will be 24 months.

Waitlist Available
Has No Placebo

University of South Florida (+9 Sites)

Boston Scientific Corporation

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Lifestyle Intervention vs Metformin for Gestational Diabetes

18 - 45
Female
Washington, United States

The goal of this clinical trial is to evaluate the effectiveness of a 6-month lifestyle intervention compared to Metformin in postpartum women who have delivered a singleton, live born infant within the last 12 weeks to 1 year and had a pregnancy complicated by gestational diabetes. The main question this study aims to answer is: Is a Lifestyle Intervention or Metformin more effective for weight loss in postpartum women with recent gestational diabetes? Researchers will compare a 6-month Lifestyle Intervention and Metformin to see if either intervention is more effective in achieving weight loss and improving health outcomes. Participants will: * Attend an in-person baseline visit to receive a Bluetooth-enabled scale and Fitbit, have blood drawn for testing, and have their height, weight, and blood pressure measured. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length. * Track diet, physical activity, and weight using the Fitbit and Looseit! apps. * Attend weekly online group sessions for the first 4 weeks, then biweekly sessions. * If not meeting weight loss goals, be randomized to either Enhanced Lifestyle Intervention or Metformin arms of the study. * If randomized to Metformin, participants will attend one in-person meeting with the study provider, get blood drawn for testing, and undergo a urine pregnancy test before starting the medication. * Continue with biweekly group sessions or have regular check-in calls. * If randomized to the Enhanced Lifestyle Intervention, participants will get a free Instacart membership, a 1:1 session with the study health counselor focused on meal planning and free grocery delivery once a week for the remainder of the study. * Participants will meet every other week via Zoom with the health counselor and other participants in the enhanced lifestyle arm. * At the end of the 6 months, all participants will come for an in-person visit to get blood drawn for testing. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length.

Phase 2
Recruiting

Milken Institute School of Public Health - The George Washington University (+1 Sites)

Wanda Nicholson, MD

Image of University of Texas Health Science Center at San Antonio in San Antonio, United States.

Tirzepatide for Muscle Health

18+
All Sexes
San Antonio, TX

Obesity and type 2 diabetes mellitus (T2DM) represent major public health concerns in the aging community. Tirzepatide, a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist recently approved for the treatment of T2DM and obesity has been shown to be effective at reducing weight, improving markers of T2DM control, and improving cardiovascular health. Utilization of tirzepatide among older adults has been on the rise since FDA approval was issued, however the effects of tirzepatide use on functional outcomes in older adults with obesity are not well established. Recent studies show that weight loss caused by tirzepatide may be driven by substantial loss of lean muscle mass, which may contribute to weakness and frailty, particularly among older adults. The proposed pilot study aims to evaluate how treatment with tirzepatide for 6 months affects muscle mass and function among older adults, and if changes in muscle mass are linked to changes in functional status over the same time period.

Phase 2
Recruiting

University of Texas Health Science Center at San Antonio

Elena Volpi, MD, PhD

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Contrave for Obesity

18 - 64
All Sexes
Ottawa, Canada

Obesity is a common chronic disease linked with increased risk for other illnesses and earlier death. Our team and others have shown that many bodily and psychological changes occur when individuals are on calorie-restricted diets. These changes might undermine dietary adherence and help to explain the relatively poor long-term efficacy of diets. These include increased appetite, increased food 'value' and 'wanting' that leads to overconsumption. Other factors include more sensitive sensory cues (e.g., smelling), higher food liking and craving, and a drop in resting energy expenditure (REE). REE has been shown to predict weight regain. The standard care for obesity may include the use of the weight-loss drug CONTRAVE®. The Federal Drug Agency (FDA) and Health Canada have approved this drug for weight management and obesity treatment. Although CONTRAVE® was designed to reduce appetite, food-related impulsivity and cravings, its mechanisms of action are unclear. In other words, the effects of CONTRAVE® on REE, executive function, and brain changes remain unknown in humans. A better understanding of how this drug works on the brain and body could lead to improvements in obesity management in the future. As such, the goal of this research is to study the effects of 4 weeks of CONTRAVE® (+ diet program) vs. control (placebo pill + diet program) on mood, body composition changes, biological/metabolic measures, and brain measures. Adults aged 18-64 with obesity will be randomized to one of two groups: diet + CONTRAVE® (CONTRAVE®, 20 participants) or diet + Placebo (Placebo, 20 participants). Both groups will be assigned the same study procedures for the entire study duration. The only difference is that Group 1 will receive CONTRAVE® while Group 2 will receive a placebo (non-medical) pill. The study design and intervention is as follows: Participants who meet all the telephone screening criteria will be invited to the Clinical EEG \& Neuroimaging Laboratory at The Royal's IMHR for an in-person screening and test-dose session. Participants who are cleared by the study physician, Dr. Pierre Blier, during the in-person screening will be enrolled in the 4-weeks trial. After the in-person screening visit, participants will attend two baseline testing visits (before starting the medication + diet program). The first will occur at the Behavioural and Metabolic Research Unit at the University of Ottawa. During this in-person visit, measures of body composition, resting energy expenditure, appetite, food craving, impulsivity, eating behaviours, taste and odour sensitivity, energy intake, and food preference will be collected. The second baseline visit (within a week of the first one) will occur at The Royal/IMHR. During this visit, participants will be asked to complete questionnaires. They will undergo an EEG recording while resting and performing computer tasks. They will also get a brain imaging scan, during which they are asked to rest and complete a computer task. Both testing sessions (University of Ottawa and Royal Ottawa testing sessions) will be repeated after four weeks of treatment. The section below provides further description and timing of these visits. As part of the treatment, you will receive an individualized dietary intervention with appropriate energy restriction from a registered dietitian at Dr. Judy Shiau's LEAF weight management clinic (called the 4-week BUDS program). The program involves weekly touch points with a registered dietitian and meal planning/coaching. The diet intervention will commence the same week as the start of the placebo/CONTRAVE®. During the 4-week intervention, participants will be asked to complete online questionnaires at various times.

Phase 4
Recruiting

LEAF Weight Managment Clinic (+2 Sites)

Pierre Blier, M.D., Ph.D

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