Multicenter, placebo-controlled trial of lorcaserin for weight management.
Open accessAbstract
BACKGROUND: Lorcaserin is a selective serotonin 2C receptor agonist that could be useful in reducing body weight. METHODS: In this double-blind clinical trial, we randomly assigned 3182 obese or overweight adults (mean body-mass index [the weight in kilograms divided by the square of the height in meters] of 36.2) to receive lorcaserin at a dose of 10 mg, or placebo, twice daily for 52 weeks. All patients also underwent diet and exercise counseling. At week 52, patients in the placebo group continued to receive placebo but patients in the lorcaserin group were randomly reassigned to receive either placebo or lorcaserin. Primary outcomes were weight loss at 1 year and maintenance of weight loss at 2 years. Serial echocardiography was used to identify patients in whom valvulopathy (as defined by the Food and Drug Administration) developed. RESULTS: At 1 year, 55.4% of patients (883 of 1595) receiving lorcaserin and 45.1% of patients (716 of 1587) receiving placebo remained in the trial; 1553 patients continued into year 2. At 1 year, 47.5% of patients in the lorcaserin group and 20.3% in the placebo group had lost 5% or more of their body weight (P<0.001), corresponding to an average loss of 5.8+/-0.2 kg with lorcaserin and 2.2+/-0.1 kg with placebo during year 1 (P<0.001). Among the patients who received lorcaserin during year 1 and who had lost 5% or more of their baseline weight at 1 year, the loss was maintained in more patients who continued to receive lorcaserin during year 2 (67.9%) than in patients who received placebo during year 2 (50.3%, P<0.001). Among 2472 patients evaluated at 1 year and 1127 evaluated at 2 years, the rate of cardiac valvulopathy was not increased with the use of lorcaserin. Among the most frequent adverse events reported with lorcaserin were headache, dizziness, and nausea. The rates of serious adverse events in the two groups were similar. CONCLUSIONS: In conjunction with behavioral modification, lorcaserin was associated with significant weight loss and improved maintenance of weight loss, as compared with placebo. (Funded by Arena Pharmaceuticals; ClinicalTrials.gov number, NCT00395135.)
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The SURMOUNT-4 trial results emphasize the need to continue pharmacotherapy to prevent weight regain and ensure the maintenance of weight reduction and its associated cardiometabolic benefits.
“The SURMOUNT-4 trial results emphasize the need to continue pharmacotherapy to prevent weight regain and ensure the maintenance of weight reduction and its associated cardiometabolic benefits.22”
From Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial (2024) · cites this paper as [22]
The Results and Discussion (page not provided) show that patients who continued lorcaserin maintained weight loss more often than those switched to placebo. The paper also reports improved cardiovascular-risk biomarkers, but it reports the BLOOM lorcaserin trial, not SURMOUNT-4, and does not establish that continued treatment maintained those biomarker benefits. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIt is common in obesity pharmacotherapy trials that more people in the placebo group are lost to follow-up than in the active treatment group.
“It is common in obesity pharmacotherapy trials that more people in the placebo group are lost to follow-up than in the active treatment group.8,10,35”
From Healthy weight loss maintenance with exercise, GLP-1 receptor agonist, or both combined followed by one year without treatment: a post-treatment analysis of a randomised placebo-controlled trial (2024) · cites this paper as [35]
The Patients and Study Completion section reports lower year-1 completion in the placebo group (45.1%) than in the lorcaserin group (55.4%), supporting the claim for this trial. The Discussion says overall discontinuation was similar to that in other large obesity trials, but does not establish that higher placebo-group loss to follow-up is common across those trials; page numbers were not supplied. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn the STEP 1 extension, weight regain was comparatively rapid following semaglutide withdrawal compared with that seen in other obesity pharmacotherapy withdrawal trials, including after semaglutide withdrawal in STEP 4.
“In the STEP 1 extension, weight regain was comparatively rapid following semaglutide withdrawal compared with that seen in other obesity pharmacotherapy withdrawal trials, including after semaglutide withdrawal in STEP 4.”
From Weight regain and cardiometabolic effects after withdrawal of semaglutide: The <scp>STEP</scp> 1 trial extension (2022) · cites this paper as [15]
The Weight Loss and Discussion sections report that patients switched from lorcaserin to placebo were less likely to maintain their weight loss than those who continued treatment. This supports citing the paper as an obesity-drug withdrawal trial, but it does not assess the STEP 1 extension, STEP 4, or whether weight regain after semaglutide withdrawal was comparatively rapid. (LLM, conf=0.82)
Experimental — accuracy not yet measuredWeight regain has previously been observed following withdrawal of obesity pharmacotherapies, including orlistat and lorcaserin-and also semaglutide, as shown in STEP 4-despite continued lifestyle intervention.
“Weight regain has previously been observed following withdrawal of obesity pharmacotherapies, including orlistat and lorcaserin—and also semaglutide, as shown in STEP 4—despite continued lifestyle intervention.”
From Weight regain and cardiometabolic effects after withdrawal of semaglutide: The <scp>STEP</scp> 1 trial extension (2022) · cites this paper as [15]
Long-term obesity pharmacotherapy may be required for weight maintenance, as cessation of pharmacological treatment is frequently followed by weight regain, even with continued lifestyle intervention.
“Long‐term obesity pharmacotherapy may be required for weight maintenance, as cessation of pharmacological treatment is frequently followed by weight regain, even with continued lifestyle intervention. 13 , 14 , 15”
From Weight regain and cardiometabolic effects after withdrawal of semaglutide: The <scp>STEP</scp> 1 trial extension (2022) · cites this paper as [15]
Clinical obesity trials with off-medication phases have not previously assessed fat mass.
“However, clinical obesity trials with off-medication phases have not previously assessed fat mass.18,19,34,35”
In the BLOOM trial extension, maintenance of weight loss was observed in 67.9% of those who continued lorcaserin compared to 50.3% of those switched to placebo at two years.
“maintenance of weight loss was observed in 67.9% of those who continued therapy compared to 50.3% of those switched to placebo at two years”
From Weight maintenance after discontinuation of GLP-1 therapies (2026) · cites this paper as [19]
The benefits of continuing semaglutide for 68 weeks rather than switching to placebo after 20 weeks are consistent with findings from other withdrawal trials of antiobesity medications.
“The benefits of continuing semaglutide treatment for 68 weeks, rather than switching to placebo after 20 weeks, are consistent with findings from other withdrawal trials of antiobesity medications.23,24”
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- Authors
- Smith, S. R., Weissman, N. J., Anderson, C. M., Sanchez, M., Chuang, E., Stubbe, S., Bays, H., & Shanahan, W. R.
- Affiliations
- Sanford Burnham Prebys Medical Discovery Institute (US)
- Georgetown University (US)
- Arena Pharmaceuticals (United States) (US)
- Louisville Metabolic and Atherosclerosis Research Center (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2010-07-15
- Volume
- 363
- Issue
- 3
- Pages
- 245-256
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2148287957
- Cited by
- 911
- References
- 58
- Citations by year
- 2026: 7 · 2025: 16 · 2024: 44 · 2023: 43 · 2022: 19 · 2021: 54 · 2020: 46 · 2019: 64 · 2018: 75 · 2017: 76 · 2016: 86 · 2015: 91 · 2014: 77 · 2013: 97 · 2012: 44
- FWCI
- 50.48
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Regulation of Appetite and Obesity
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Keywords
- lorcaserin, weight loss, obesity, overweight, weight loss maintenance, cardiac valvulopathy, behavior change, diet and exercise counseling, adverse events, drug safety, antidepressant-induced weight gain, appetite suppressants, body mass index, echocardiography
- MeSH terms
- Adult, Behavior Therapy, Benzazepines, Blood Pressure, Cardiovascular Diseases, Combined Modality Therapy, Double-Blind Method, Female, Heart Valve Diseases, Humans, Insulin, Male, Middle Aged, Obesity, Risk Factors, Weight Loss, Serotonin Receptor Agonists, Anti-Obesity Agents, Overweight, Waist Circumference, Intention to Treat Analysis, Serotonin 5-HT2 Receptor Agonists
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