Jena Shaw Tronieri1, Thomas A Wadden2, Olivia A Walsh2, Robert I Berkowitz3, Naji Alamuddin4, Kathryn Gruber2, Sharon Leonard2, Ariana M Chao5. 1. Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, United States of America. Electronic address: jena.tronieri@pennmedicine.upenn.edu. 2. Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, United States of America. 3. Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, United States of America; The Children's Hospital of Philadelphia, Department of Child and Adolescent Psychiatry, Philadelphia, PA, United States of America. 4. Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, United States of America; Perelman School of Medicine at the University of Pennsylvania, Department of Medicine, Philadelphia, PA, United States of America; Royal College of Surgeons in Ireland/Medical University of Bahrain/King Hamad University Hospital, Bahrain. 5. Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, United States of America; University of Pennsylvania School of Nursing, Department of Biobehavioral Health Sciences, Philadelphia, PA, United States of America.
Abstract
BACKGROUND: This pilot study evaluated whether adding phentermine to liraglutide would induce further weight loss in participants who had previously lost weight with liraglutide alone. SUBJECTS/ METHODS:Participants were 45 adults with obesity (75.6% female, 55.6% white, body mass index = 34.3 ± 4.7 kg/m2) who had lost an average of 12.6 ± 6.8% of initial weight during a prior 1-year randomized trial with liraglutide and intensive behavioral treatment. Participants were re-randomized, in a double-blinded fashion, to liraglutide 3.0 mg plus phentermine 15.0 mg (liraglutide-phentermine) or liraglutide plus placebo (liraglutide-placebo). Participants also were provided with four, 15-minute counseling sessions during the 12-week extension study. RESULTS: At week 12, the liraglutide-phentermine and liraglutide-placebo groups lost a mean (±SEM) of 1.6 ± 0.6% and 0.1 ± 0.5% of re-randomization weight, respectively (p = 0.073). Two (9.1%) liraglutide-phentermine participants and one (4.3%) liraglutide-placeboparticipant lost ≥5% of re-randomization weight; 19 (86.4%) and 16 (69.9%) participants, respectively, maintained their full weight loss achieved in the prior 1-year trial (p = 0.125). Liraglutide-phentermine participants generally reported larger reductions in hunger and food preoccupation than liraglutide-placebo participants during the first 8 weeks of the extension study. CONCLUSIONS: The combination of liraglutide and phentermine appeared to be well-tolerated but did not produce additional clinically meaningful weight loss in individuals who had already lost 12.6% of initial weight with liraglutide alone. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT02911818.
RCT Entities:
BACKGROUND: This pilot study evaluated whether adding phentermine to liraglutide would induce further weight loss in participants who had previously lost weight with liraglutide alone. SUBJECTS/ METHODS:Participants were 45 adults with obesity (75.6% female, 55.6% white, body mass index = 34.3 ± 4.7 kg/m2) who had lost an average of 12.6 ± 6.8% of initial weight during a prior 1-year randomized trial with liraglutide and intensive behavioral treatment. Participants were re-randomized, in a double-blinded fashion, to liraglutide 3.0 mg plus phentermine 15.0 mg (liraglutide-phentermine) or liraglutide plus placebo (liraglutide-placebo). Participants also were provided with four, 15-minute counseling sessions during the 12-week extension study. RESULTS: At week 12, the liraglutide-phentermine and liraglutide-placebo groups lost a mean (±SEM) of 1.6 ± 0.6% and 0.1 ± 0.5% of re-randomization weight, respectively (p = 0.073). Two (9.1%) liraglutide-phentermineparticipants and one (4.3%) liraglutide-placebo participant lost ≥5% of re-randomization weight; 19 (86.4%) and 16 (69.9%) participants, respectively, maintained their full weight loss achieved in the prior 1-year trial (p = 0.125). Liraglutide-phentermineparticipants generally reported larger reductions in hunger and food preoccupation than liraglutide-placebo participants during the first 8 weeks of the extension study. CONCLUSIONS: The combination of liraglutide and phentermine appeared to be well-tolerated but did not produce additional clinically meaningful weight loss in individuals who had already lost 12.6% of initial weight with liraglutide alone. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT02911818.
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