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Last Updated: January 5, 2025

CLINICAL TRIALS PROFILE FOR SIBUTRAMINE HYDROCHLORIDE


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All Clinical Trials for SIBUTRAMINE HYDROCHLORIDE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00221442 ↗ Zonegran in the Treatment of Binge Eating Disorder Associated With Obesity Completed Eisai Inc. Phase 3 2005-08-01 The specific aim of this study is to examine the efficacy and safety of zonisamide compared with placebo in outpatients with binge eating disorder associated with obesity.
NCT00134199 ↗ A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese Subjects Completed Pfizer Phase 2/Phase 3 2005-03-01 To evaluate the effect of 6-month administration of CP-945,598 on: - weight loss and waist circumference, - blood pressure, cholesterol, glucose - other biochemical variables like insulin, leptin, ghrelin, adiponectin, PAI 1, TNF-α and hsCRP - the relationship between the concentration of the drug on the blood and the above parameters - physical and psychosocial functioning, weight related symptoms, treatment satisfaction, appetite/hunger/satiety/craving and mood, anxiety, anhedonia and depression
NCT00037752 ↗ Sibutramine to Reduce Weight Gain and Improve Smoking Cessation Rates Completed National Heart, Lung, and Blood Institute (NHLBI) N/A 2002-09-01 The purpose of this study is to determine if sibutramine will decrease post-cessation weight gain and cigarette smoking in overweight and obese smokers who quit smoking.
NCT00037752 ↗ Sibutramine to Reduce Weight Gain and Improve Smoking Cessation Rates Completed University of Tennessee N/A 2002-09-01 The purpose of this study is to determine if sibutramine will decrease post-cessation weight gain and cigarette smoking in overweight and obese smokers who quit smoking.
NCT00044187 ↗ The Assessment of a Weight-Gain Agent for the Treatment of Olanzapine-Associated Anti-Obesity Agent in Patients With Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder Completed Eli Lilly and Company Phase 4 2001-04-01 Olanzapine is currently marketed for the treatment of schizophrenia and acute manic episodes with bipolar 1 disorder. This Anti-obesity Agent is currently marketed for the management of obesity. In this study, the Anti-obesity Agent is being tested to see if it can treat weight gain that may be associated with taking olanzapine. The purposes of this study are to determine the safety of olanzapine when given in combination with the Anti-obesity Agent and any side effects that might be associated with it and whether weight-gain agent can help treat weight gain that may be associated with taking olanzapine.
NCT00212173 ↗ Adolescent Weight Management Study Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) N/A 1969-12-31 Protocol #1:The goals of this study was to examine whether increased weight loss in obese adolescent is induced when the weight loss medication sibutramine is added to a family-based, behavioral weight control program. Protocol #2: This study aims to improve the behavioral treatment of obesity during adolescence. A behavioral program using regular foods will be compared to a behavioral program using a structured meal plan (a portion-controlled approach with liquid-meal replacements [nutritional supplements]). This structured approach may be better for the promotion of weight loss compared to a diet of regular foods.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for SIBUTRAMINE HYDROCHLORIDE

Condition Name

284320051015202530ObesityOverweightVasovagal SyncopeHypertension[disabled in preview]
Condition Name for SIBUTRAMINE HYDROCHLORIDE
Intervention Trials
Obesity 28
Overweight 4
Vasovagal Syncope 3
Hypertension 2
[disabled in preview] 0
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Condition MeSH

119940-10123456789101112ObesityWeight LossOverweightBinge-Eating Disorder[disabled in preview]
Condition MeSH for SIBUTRAMINE HYDROCHLORIDE
Intervention Trials
Obesity 11
Weight Loss 9
Overweight 9
Binge-Eating Disorder 4
[disabled in preview] 0
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Clinical Trial Locations for SIBUTRAMINE HYDROCHLORIDE

Trials by Country

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Trials by Country for SIBUTRAMINE HYDROCHLORIDE
Location Trials
United States 82
Brazil 3
Canada 2
Greece 2
Korea, Republic of 1
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Trials by US State

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Trials by US State for SIBUTRAMINE HYDROCHLORIDE
Location Trials
New York 6
Texas 6
Florida 6
California 5
Minnesota 4
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Clinical Trial Progress for SIBUTRAMINE HYDROCHLORIDE

Clinical Trial Phase

26.3%26.3%44.7%0024681012141618Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for SIBUTRAMINE HYDROCHLORIDE
Clinical Trial Phase Trials
Phase 4 10
Phase 3 10
Phase 2/Phase 3 1
[disabled in preview] 17
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Clinical Trial Status

73.7%13.2%5.3%7.9%0051015202530CompletedTerminatedNot yet recruiting[disabled in preview]
Clinical Trial Status for SIBUTRAMINE HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 28
Terminated 5
Not yet recruiting 2
[disabled in preview] 3
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Clinical Trial Sponsors for SIBUTRAMINE HYDROCHLORIDE

Sponsor Name

trials01234567AbbottUniversity of CalgaryNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)[disabled in preview]
Sponsor Name for SIBUTRAMINE HYDROCHLORIDE
Sponsor Trials
Abbott 7
University of Calgary 3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 3
[disabled in preview] 6
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Sponsor Type

44.9%42.9%12.2%0-2024681012141618202224OtherIndustryNIH[disabled in preview]
Sponsor Type for SIBUTRAMINE HYDROCHLORIDE
Sponsor Trials
Other 22
Industry 21
NIH 6
[disabled in preview] 0
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SIBUTRAMINE HYDROCHLORIDE Market Analysis and Financial Projection

Sibutramine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Sibutramine Hydrochloride

Sibutramine hydrochloride, marketed under the brand name Meridia, is a drug that was once widely used for the treatment of obesity. It functions by inhibiting the reuptake of norepinephrine and serotonin, leading to a reduction in appetite and an increase in satiety.

Clinical Trials and Efficacy

Early Clinical Trials

In early clinical trials, sibutramine demonstrated significant efficacy in weight loss. A double-blind, randomized placebo-controlled trial involving 173 patients showed a dose-dependent reduction in body weight, with doses of 10, 15, 20, and 30 mg per day resulting in significant weight loss compared to the placebo group[4].

A prospective randomized controlled trial conducted within a health maintenance organization involved 588 obese patients. Patients were randomized to either a weight management program alone or the program plus sibutramine for 12 months. The results showed that patients receiving sibutramine had greater reductions in weight, body mass index (BMI), and percentage body fat compared to those in the program alone[1].

Safety Concerns and the SCOUT Trial

However, subsequent trials raised significant safety concerns. The Sibutramine Cardiovascular Outcomes (SCOUT) trial, which was a major study assessing the cardiovascular safety of sibutramine, revealed a 16% increase in the risk of major adverse cardiovascular events (including non-fatal heart attacks, non-fatal strokes, resuscitation after cardiac arrest, and cardiovascular death) in patients treated with sibutramine compared to those taking a placebo[3].

This trial led the FDA to recommend against the continued use of Meridia due to the increased risk of adverse cardiovascular events outweighing any modest weight loss benefits.

Adverse Events and Safety Profile

The safety profile of sibutramine has been a significant concern. Common adverse events reported in clinical trials include dry mouth, tachycardia, constipation, hypertension, insomnia, and headache. More serious adverse events, such as significant increases in blood pressure and heart rate, were also observed, leading to dosage adjustments or discontinuation of the drug[1].

Market Analysis

Historical Market Performance

The global sibutramine hydrochloride market had seen growth prior to the drug's withdrawal from the market. In 2014, the market revenue was valued at millions of USD, and it grew until 2018. However, the market's future projections were significantly impacted by the FDA's recommendation against its use[2].

Current Market Status

Following the FDA's recommendation and subsequent market withdrawal, the sibutramine hydrochloride market has essentially collapsed. The drug is no longer prescribed or sold in most countries due to its adverse cardiovascular effects.

Regional Impact

The market impact was felt globally, with regions such as North America, Europe, China, Japan, and others seeing a decline in sibutramine hydrochloride sales and production. The market analysis reports that were once optimistic about the drug's future now reflect a stark reality of a market that has been severely curtailed by safety concerns[2][5].

Projections and Future Outlook

Given the FDA's recommendation and the subsequent withdrawal of sibutramine from the market, there are no positive projections for the future of this drug. The market for sibutramine hydrochloride is effectively non-existent, and any previous forecasts for growth have been rendered obsolete.

Alternative Treatments

The focus has shifted to other obesity treatments that have a safer profile. Pharmaceutical companies and researchers are now exploring alternative drugs and therapies that can provide effective weight loss without the significant cardiovascular risks associated with sibutramine.

Key Takeaways

  • Clinical Efficacy: Sibutramine hydrochloride was effective in reducing weight in clinical trials.
  • Safety Concerns: The drug was associated with a significant increase in adverse cardiovascular events, leading to its market withdrawal.
  • Market Impact: The global market for sibutramine hydrochloride collapsed following the FDA's recommendation against its use.
  • Future Outlook: There are no positive projections for the future of sibutramine hydrochloride due to its safety profile.

FAQs

What was the primary mechanism of action of sibutramine hydrochloride?

Sibutramine hydrochloride worked by inhibiting the reuptake of norepinephrine and serotonin, leading to reduced appetite and increased satiety[4].

Why was sibutramine hydrochloride withdrawn from the market?

Sibutramine hydrochloride was withdrawn due to a 16% increase in the risk of major adverse cardiovascular events as demonstrated in the SCOUT trial[3].

What were the common adverse events associated with sibutramine hydrochloride?

Common adverse events included dry mouth, tachycardia, constipation, hypertension, insomnia, and headache[1].

Is sibutramine hydrochloride still available for prescription?

No, sibutramine hydrochloride is no longer prescribed or sold in most countries due to its adverse cardiovascular effects[3].

What alternatives are available for obesity treatment?

Other obesity treatments, including different medications and lifestyle interventions, are now being recommended and researched as safer alternatives to sibutramine hydrochloride.

Sources

  1. The American Journal of Managed Care: "The Long-term Outcomes of Sibutramine Effectiveness on Weight Management in a Health Maintenance Organization"[1].
  2. Market Research Store: "Global Sibutramine Hydrochloride Industry Market Report 2019"[2].
  3. FDA: "FDA Recommends Against the Continued Use of Meridia (sibutramine hydrochloride)"[3].
  4. PubMed: "A double-blind randomized placebo-controlled trial of sibutramine"[4].
  5. Prof Research: "Sibutramine Hydrochloride Market Size, Share ... - Prof Research"[5].

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