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Lorcaserin

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1. A Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen in Healthy Participants

A Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen in Healthy Participants A Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen in Healthy Participants - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration (...) or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. A Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen in Healthy Participants The safety and scientific validity of this study is the responsibility of the study sponsor

2018 Clinical Trials

2. Lorcaserin and Renal Outcomes in Obese and Overweight Patients in the CAMELLIA-TIMI 61 Trial Full Text available with Trip Pro

Lorcaserin and Renal Outcomes in Obese and Overweight Patients in the CAMELLIA-TIMI 61 Trial Obesity is thought to increase renal hyperfiltration, thereby increasing albuminuria and the progression of renal disease. The effect of pharmacologically mediated weight loss on renal outcomes is not well-described. Lorcaserin, a selective serotonin 2C receptor agonist that promotes appetite suppression, led to sustained weight loss without any increased risk for major adverse cardiovascular (CV (...) ) events in the CAMELLIA-TIMI 61 trial (Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients-Thrombolysis in Myocardial Infarction 61).CAMELLIA-TIMI 61 randomly assigned 12 000 overweight or obese patients with or at high risk for atherosclerotic CV disease to lorcaserin or placebo on a background of lifestyle modification. The primary renal outcome was a composite of new or worsening persistent micro- or macroalbuminuria, new or worsening chronic kidney disease, doubling

2019 EvidenceUpdates

3. Effect of lorcaserin on prevention and remission of type 2 diabetes in overweight and obese patients (CAMELLIA-TIMI 61): a randomised, placebo-controlled trial. Full Text available with Trip Pro

Effect of lorcaserin on prevention and remission of type 2 diabetes in overweight and obese patients (CAMELLIA-TIMI 61): a randomised, placebo-controlled trial. There is a direct relationship between bodyweight and risk of diabetes. Lorcaserin, a selective serotonin 2C receptor agonist that suppresses appetite, has been shown to facilitate sustained weight loss in obese or overweight patients. We aimed to evaluate the long-term effects of lorcaserin on diabetes prevention and remission.In (...) this randomised, double-blind, placebo-controlled trial done in eight countries, we recruited overweight or obese patients (body-mass index ≥27 kg/m2) with or at high risk for atherosclerotic vascular disease. Eligible patients were aged 40 years or older; patients at high risk for atherosclerotic vascular disease had to be aged 50 years or older with diabetes and at least one other risk factor. Patients were randomly assigned to receive either lorcaserin (10 mg twice daily) or matching placebo. Additionally

2018 Lancet Controlled trial quality: predicted high

4. Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients. Full Text available with Trip Pro

Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients. Lorcaserin, a selective serotonin 2C receptor agonist that modulates appetite, has proven efficacy for weight management in overweight or obese patients. The cardiovascular safety and efficacy of lorcaserin are undefined.We randomly assigned 12,000 overweight or obese patients with atherosclerotic cardiovascular disease or multiple cardiovascular risk factors to receive either lorcaserin (10 mg twice daily) or placebo (...) year, weight loss of at least 5% had occurred in 1986 of 5135 patients (38.7%) in the lorcaserin group and in 883 of 5083 (17.4%) in the placebo group (odds ratio, 3.01; 95% confidence interval [CI], 2.74 to 3.30; P<0.001). Patients in the lorcaserin group had slightly better values with respect to cardiac risk factors (including blood pressure, heart rate, glycemic control, and lipids) than those in the placebo group. During a median follow-up of 3.3 years, the rate of the primary safety outcome

2018 NEJM Controlled trial quality: predicted high

5. A Randomized Trial of Lorcaserin and Lifestyle Counseling for Maintaining Weight Loss Achieved with a Low-Calorie Diet Full Text available with Trip Pro

A Randomized Trial of Lorcaserin and Lifestyle Counseling for Maintaining Weight Loss Achieved with a Low-Calorie Diet Improving the maintenance of lost weight remains a critical challenge, which can be addressed by long-term behavioral and/or pharmacological interventions.This study investigated the efficacy of combined behavioral and pharmacological treatment in facilitating weight loss maintenance (WLM) in 137 adults (86.1% female; 68.6% black; BMI = 37.0 ± 5.6 kg/m2 ) who had lost ≥ 5 (...) % of initial weight during a 14-week low-calorie diet (LCD) program (mean = 9.3 ± 2.9%). Participants were randomly assigned to lorcaserin (10 mg twice a day) or placebo and were provided 16 group WLM counseling sessions over 52 weeks.At 24 weeks post randomization, more lorcaserin-treated than placebo-treated participants maintained a ≥ 5% loss (73.9% vs. 57.4%; P = 0.033), and the lorcaserin-treated participants lost an additional 2.4 ± 0.8 kg versus a 0.6 ± 0.8 kg gain for placebo (P = 0.010). However

2018 EvidenceUpdates

6. Obesity: European patients protected against lorcaserin, a psychotropic drug sold as an appetite suppressant

Obesity: European patients protected against lorcaserin, a psychotropic drug sold as an appetite suppressant Prescrire IN ENGLISH - Spotlight ''Obesity: European patients protected against lorcaserin, a psychotropic drug sold as an appetite suppressant'', 1 May 2014 {1} {1} {1} | | > > > Obesity: European patients protected against lorcaserin, a psychotropic drug sold as an appetite suppressant Spotlight Every month, the subjects in Prescrire’s Spotlight. 100 most recent :  |    (...) |   |   |   |   |   |   |   |  Spotlight Obesity: European patients protected against lorcaserin, a psychotropic drug sold as an appetite suppressant It is unjustifiable to expose patients to the dangers of lorcaserin, which has no tangible effect on the complications of obesity or even on weight. The European Medicines Agency was right to refuse it a marketing authorisation. Treatment of obesity or just excess weight depends first

2014 Prescrire

7. Effect of lorcaserin on weight reduction in persons with obstructive sleep apnea (OSA): a combined subgroup analysis from three randomized, controlled clinical trials. Full Text available with Trip Pro

Effect of lorcaserin on weight reduction in persons with obstructive sleep apnea (OSA): a combined subgroup analysis from three randomized, controlled clinical trials. To evaluate weight loss with lorcaserin in persons with obstructive sleep apnea (OSA).This retrospective analysis evaluated weight loss of lorcaserin (10 mg twice daily) versus placebo in persons with obesity or overweight persons with OSA from a pooled database of three randomized, controlled trials. Primary end points were (...) reductions in the baseline body weight of ≥5% and ≥10% at year 1 and overall weight change at year 1. Changes in heart rate and blood pressure were also evaluated.A total of 336 persons with OSA were identified in the overall pooled population (N = 6,636). At year 1, more patients receiving lorcaserin lost ≥5% (47.2% lorcaserin vs. 25.6% placebo; p < 0.0001) and 10% (22.2% lorcaserin vs. 13.1% placebo; p < 0.0354) of their baseline body weight. Weight loss at year 1 was 6.4 kg versus 3.5 kg

2019 Obesity science & practice Controlled trial quality: uncertain

8. Lorcaserin for prevention and remission of type 2 diabetes mellitus in people with overweight or obesity: protocol for a systematic review and meta-analysis. Full Text available with Trip Pro

Lorcaserin for prevention and remission of type 2 diabetes mellitus in people with overweight or obesity: protocol for a systematic review and meta-analysis. High body mass index (BMI) is associated with risk of diabetes. Lorcaserin is a selective 5-hydroxytryptamine 2C agonist which exerts robust benefits on long-term weight loss by suppressing appetite among adults with overweight or obesity. The magnitude of efficacy of lorcaserin for preventing and remitting type 2 diabetes mellitus (T2DM (...) ) among those people remains undefined. Therefore, we plan to conduct this systematic review and meta-analysis to aggregate data from all published studies with regard to the issue to acquire reliable evidence.We will search various databases for relevant trials published up to June 2019. Randomised controlled trials investigating the efficacy of lorcaserin for preventing and remitting T2DM among overweight and obese population will be included. A standardised data form will be used to complete data

2019 BMJ open

9. The serotonin-2C agonist Lorcaserin delays intravenous choice and modifies the subjective and cardiovascular effects of cocaine: A randomized, controlled human laboratory study. (Abstract)

The serotonin-2C agonist Lorcaserin delays intravenous choice and modifies the subjective and cardiovascular effects of cocaine: A randomized, controlled human laboratory study. Lorcaserin is a modestly selective agonist for 2C serotonin receptors (5-HT2CR) approved for weight-loss therapy. This class can attenuate cue-induced responding and drug taking in preclinical studies, but effects in humans have not been reported.We evaluated effects of single 10 mg doses of lorcaserin on the subjective (...) and reinforcing effects of cocaine, using a randomized, double-blind, within-subject, cross-over design. Male, non-treatment-seeking, regular cocaine users received either single doses of oral placebo (n = 9) or lorcaserin (n = 9), followed by low- or high- doses of intravenous cocaine (0.23 or 0.46 mg/kg-injection). They were then allowed to self-administer the lower dose of cocaine.Cocaine was well tolerated after lorcaserin pretreatment. Oral lorcaserin did not modify the number of cocaine injections self

2019 Pharmacology, biochemistry, and behavior Controlled trial quality: uncertain

10. A randomized controlled trial of lorcaserin and lifestyle counselling for weight loss maintenance: changes in emotion- and stress-related eating, food cravings and appetite. Full Text available with Trip Pro

A randomized controlled trial of lorcaserin and lifestyle counselling for weight loss maintenance: changes in emotion- and stress-related eating, food cravings and appetite. Anti-obesity medication may help people maintain diet-induced reductions in appetite. The present exploratory analysis assessed the effects of lorcaserin on changes at 24 weeks post-randomization in emotion- and stress-related eating, food cravings and other measures of appetite (i.e. binge eating, cognitive restraint (...) , disinhibition, hunger, preoccupation with eating and fullness). The parent study investigated the efficacy of combined lorcaserin and behavioural treatment in facilitating weight loss maintenance (WLM) in 137 adults (mean age = 46.1 years, 86.1% female, 68.6% black) who had lost ≥5% of initial weight during a 14-week, low-calorie diet (LCD) run-in. Participants were randomly assigned to lorcaserin or placebo and were provided with group WLM counselling sessions. Emotion- and stress-related eating, food

2019 Clinical Obesity Controlled trial quality: uncertain

11. Lorcaserin treatment decreases body weight and improves cardiometabolic risk factors of obese adults: A 6-month-long, randomized, placebo-controlled, double-blind clinical trial. (Abstract)

Lorcaserin treatment decreases body weight and improves cardiometabolic risk factors of obese adults: A 6-month-long, randomized, placebo-controlled, double-blind clinical trial. Lorcaserin is a serotonin 2c receptor agonist, which promotes weight loss while improving type 2 diabetes and atherogenic lipid profile without higher rates of major cardiovascular events. The full spectrum of the possible lorcaserin-induced cardiometabolic improvements remains to be clarified. Thus, we investigated (...) how lorcaserin administration may alter cardiovascular disease risk, either independently or through changes in body weight, measuring, for the first time, lipid particle quantification, lipid peroxidation, appetite-regulating hormones and the mRNA expression of 5-HT2C receptor. Forty-eight obese subjects were enrolled in this 6-month-long, randomized (1:1), placebo-controlled, double-blinded clinical trial. Lorcaserin treatment reduced fat mass (p<.001), the Fatty Liver Index (p<.0001) and energy

2019 obesity & metabolism Controlled trial quality: predicted high

12. Effect of lorcaserin in different age groups: a post hoc analysis of patients from the BLOOM, BLOSSOM and BLOOM-DM studies. Full Text available with Trip Pro

Effect of lorcaserin in different age groups: a post hoc analysis of patients from the BLOOM, BLOSSOM and BLOOM-DM studies. The elderly population is projected to be the fastest growing group of individuals with obesity group in the United States. As such, there is merit in examining factors that contribute to healthy aging and weight management. The effects of newer weight loss medications approved after 2013 have been studied but are not often assessed specifically in older persons.This post (...) hoc analysis evaluated the magnitude of weight loss in adults across age quartiles with lorcaserin, a serotonin (5-HT) 2C receptor agonist indicated as an adjunct to a reduced-caloric diet and increased physical activity for chronic weight management. Data from three lorcaserin pivotal phase 3 studies were used in this analysis. Data for patients with overweight/obesity without type 2 diabetes (T2D; BLOOM/BLOSSOM; body mass index [BMI] 27.0-29.9 kg/m2 and ≥1 comorbidity or BMI 30.0-45.0 kg/m2

2019 Obesity science & practice Controlled trial quality: uncertain

13. Multicentre, placebo-controlled trial of lorcaserin for weight management in Chinese population. (Abstract)

Multicentre, placebo-controlled trial of lorcaserin for weight management in Chinese population. This study aimed to evaluate the effects of lorcaserin on body weight, cardiovascular risk factors, and safety in obese patients in Taiwan.In this double-blind, randomised controlled trial, 171 obese adults were assigned to receive lorcaserin at a dose of 10mg, or placebo, twice a day for 24weeks. Diet and exercise counselling were given to all patients through the treatment period. Primary outcomes (...) were proportion of patients achieving at least 5% and 10% reduction in body weight and mean change in body weight. Safety and tolerability endpoints such as Beck Depression Inventory-II, blood biochemistry, vital signs, and electrocardiogram were monitored.More patients receiving lorcaserin lost at least 5% body weight than receiving placebo (52.4% and 28.1%, P=0.001) with an average weight reduction of 5.8kg (95% CI: -6.91, -4.70) in lorcaserin group and those of 3.6kg (95% CI: -4.95, -2.33

2018 Obesity research & clinical practice Controlled trial quality: predicted high

14. Lorcaserin and metabolic disease: weight-loss dependent and independent effects. Full Text available with Trip Pro

Lorcaserin and metabolic disease: weight-loss dependent and independent effects. Weight management pharmacotherapies can improve metabolic diseases through weight-dependent and weight-independent effects. Lorcaserin is a selective 5-hydroxytryptamine 2C receptor agonist. The objective of this analysis is to quantify the relative contribution of weight loss to the treatment effects of lorcaserin 10 mg twice a day on key metabolic parameters.This retrospective analysis evaluated 6,897 patients (...) with overweight or obesity (with or without diabetes mellitus) across three randomized, placebo-controlled, double-blind, 52-week clinical trials that evaluated lorcaserin 10 mg twice daily (BID; NCT00395135, NCT00603902, and NCT00603291); 509 patients from only one of the studies had type 2 diabetes mellitus. A mediation analysis was applied to help rank the relative contribution of weight loss to metabolic study outcomes.According to this mediation analysis, lorcaserin 10 mg BID improved a spectrum

2018 Obesity science & practice Controlled trial quality: uncertain

15. Health-related quality of life in randomized controlled trials of lorcaserin for obesity management: what mediates improvement? (Abstract)

Health-related quality of life in randomized controlled trials of lorcaserin for obesity management: what mediates improvement? Lorcaserin, plus diet and exercise, has demonstrated significant weight loss and improved cardiometabolic parameters vs. placebo in patients with overweight/obesity in three randomized, placebo-controlled trials. We examined whether lorcaserin is also associated with greater improvements in health-related quality of life (HRQOL) and whether these improvements (...) are wholly attributable to weight loss. Pooled data from Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM), Behavioral Modification and Lorcaserin Second Study for Obesity Management (BLOSSOM) and BLOOM-Diabetes Mellitus (BLOOM-DM) trials were analysed (n = 5624). HRQOL was assessed at baseline and 52 weeks using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire. Multiple mediation analyses were conducted to evaluate the mechanisms underlying

2018 Clinical Obesity Controlled trial quality: uncertain

16. Lorcaserin plus lifestyle modification for weight loss maintenance: Rationale and design for a randomized controlled trial. (Abstract)

Lorcaserin plus lifestyle modification for weight loss maintenance: Rationale and design for a randomized controlled trial. Few studies have examined the efficacy of recently approved medications for chronic weight management in facilitating the maintenance of lost weight. This paper provides an overview of the design and rationale for a trial investigating whether lorcaserin, when combined with behavioral weight loss maintenance sessions (WLM), will facilitate the maintenance of losses of ≥5 (...) % of initial weight.In this two-phase trial, participants with obesity will enroll in a 14-week run-in diet program consisting of weekly group lifestyle modification sessions and a 1000-1200kcal/d meal replacement diet. Participants who complete this weight induction phase and lose at least 5% of initial weight will then be randomized to 52weeks of WLM plus lorcaserin or WLM plus placebo. We hypothesize that at 52weeks post randomization, participants assigned to WLM plus lorcaserin will achieve

2018 Contemporary clinical trials Controlled trial quality: predicted high

17. Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Obese Patients

Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Obese Patients Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Obese Patients - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please (...) remove one or more studies before adding more. Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Obese Patients The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03720574 Recruitment

2018 Clinical Trials

18. Design and rationale for the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients-Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) trial. (Abstract)

Design and rationale for the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients-Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) trial. Lorcaserin, a selective serotonin 2C receptor agonist, is an effective pharmacologic weight-loss therapy that improves several cardiovascular risk factors. The long-term clinical cardiovascular and metabolic safety and efficacy in patients with elevated cardiovascular risk are unknown.CAMELLIA-TIMI 61 (NCT02019264 (...) ) is a randomized, double-blind, placebo-controlled, multinational clinical trial designed to evaluate the safety and efficacy of lorcaserin with regard to major adverse cardiovascular events and progression to diabetes in overweight or obese patients at high cardiovascular risk. Overweight or obese patients either with established cardiovascular disease or with diabetes and at least 1 other cardiovascular risk factor were randomized in a 1:1 ratio to lorcaserin 10 mg twice daily or matching placebo

2018 American Heart Journal Controlled trial quality: predicted high

19. Effect of Lorcaserin Alone and in Combination with Phentermine on Food Cravings After 12-Week Treatment: A Randomized Substudy. Full Text available with Trip Pro

Effect of Lorcaserin Alone and in Combination with Phentermine on Food Cravings After 12-Week Treatment: A Randomized Substudy. This study evaluated the effect of lorcaserin 10 mg twice daily (LOR BID), or with phentermine 15 mg once daily (LOR BID + PHEN QD) and 15 mg twice daily (LOR BID + PHEN BID), in conjunction with energy restriction on food cravings.Two hundred and thirty-five patients without diabetes but with obesity or overweight and ≥ 1 comorbidity received LOR BID, LOR BID + PHEN (...) . Cravings assessed by COEQ reduced from baseline in all groups. In general, the combination treatments were more effective than lorcaserin alone. At week 12, except for fruit juice and dairy products, general and specific cravings reduced in LOR BID + PHEN BID compared with LOR BID (P < 0.05).Lorcaserin in combination with phentermine improves control of food cravings during short-term energy restriction.© 2018 The Obesity Society.

2018 Obesity Controlled trial quality: uncertain

20. Lorcaserin: Real World Experience in an Insurance-Based Weight Management Clinic

Lorcaserin: Real World Experience in an Insurance-Based Weight Management Clinic Lorcaserin: Real World Experience in an Insurance-Based Weight Management Clinic - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding (...) more. Lorcaserin: Real World Experience in an Insurance-Based Weight Management Clinic The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03552107 Recruitment Status : Active, not recruiting First Posted : June 11, 2018 Last Update Posted : June 11, 2018 Sponsor: Scripps Whittier Diabetes Institute

2018 Clinical Trials

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