A selective serotonin receptor agonist for weight loss and management of menopausal vasomotor symptoms in overweight midlife women: a pilot study

Abstract

study concept and design, analysis and interpretation of data, drafting and revising the paper, and have seen and approved the final version of the manuscript. EK-Dr. Kapoor was the co-principal investigator on the study. She contributed to development of the study protocol, recruitment of participants, and their follow-up in the study. She is the primary author of the manuscript._SSF -Dr. Faubion was a co-principal investigator for the study. She and Dr. Croghan collaborated in obtaining funding for the study concept and with Drs. Croghan and Kapoor participated in the study design. She and Drs. Kapoor and Hurt were responsible for safety screening for study entry and the safety oversight of the study participants while on study. She also participated in the review and interpretation of study results, and critical revision of the manuscript for important intellectual content. RTH -participated in the study design and was responsible for safety screening for study entry and the safety oversight of the study participants while on study. He also participated in the review and interpretation of study results, and critical revision of the manuscript for important intellectual content. KF and DRS participated in the study design and were responsible for data quality checks and data analysis; they also had full access to all the data in the study and take full responsibility for the integrity of the data and the accuracy of the data analysis as well as participating in the manuscript reviews and edits. SCF-reviewed the study flow, screened the study participants, oversaw all the study visits and lorcaserin treatments, as well as worked with the study clinicians and PI to address patient safety issues and with the PI and statistician to clean out the electronic data as well as provide reviews and edits to the manuscript. ITC -Dr. Croghan was a co-principal investigator on the study. She conceived the study concept and design; collaborated with Drs. Faubion and Kapoor in refining the working study design; and collaborated with Dr. Faubion in obtained study funding. She provided administrative, technical, and material support; she, along with Drs. Faubion and Kapoor, had full oversight of the study conduct during data collection; had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis; and participated in critical revision of the manuscript for important intellectual content.

The 2023 nonhormone therapy position statement of The North American Menopause Society

“…33 In an open-label single-arm pilot study of a weight-loss medication (selective serotonin 2C [5-HT2C] receptor agonist) tested in 20 women, after 12-weeks there were both a decrease in weight and significant improvement in VMS (decline, 5.4 hot flashes/d) from baseline to week 12. 37 The study also found that after the weight-loss medication was stopped, there was a rapid increase in VMS with a return to baseline weight, further supporting the notion that weight loss improved VMS. However, these studies are either small pilot studies, nonrandomized trials, or post hoc analyses of studies designed for a different purpose.…”

“…Weight loss may have greater effects in reducing VMS when women are earlier in the transition 33 . In an open-label single-arm pilot study of a weight-loss medication (selective serotonin 2C [5-HT2C] receptor agonist) tested in 20 women, after 12-weeks there were both a decrease in weight and significant improvement in VMS (decline, 5.4 hot flashes/d) from baseline to week 12 37 . The study also found that after the weight-loss medication was stopped, there was a rapid increase in VMS with a return to baseline weight, further supporting the notion that weight loss improved VMS.…”