120
Participants
Start Date
July 11, 2024
Primary Completion Date
May 31, 2029
Study Completion Date
December 31, 2029
Metabolic surgery
Patients receive either RYGB or SG. The surgical risk, differential impact of each procedure on body weight and other obesity-related diseases, presence of other medical and mental problems, patient's behavioral factors (e.g., postoperative compliance, active smoking), medications, and goals will be considered when the patient and local medical team make a shared decision about the most appropriate surgical procedure
Incretin-Based Therapy
Three incretin-based medications that have been approved for treatment of obesity including liraglutide, semaglutide, or tirzepatide will be used in the nonsurgical group. Any of these 3 medications (in the injection or oral from) based on availability in each country, access, and clinical indications can be used. If possible, patients will be placed on high-dose tirzepatide (Mounjaro or Zepbound 15 mg once weekly injection) or high-dose semaglutide (Wegovy 2.4 mg once weekly injection or Ozempic 2 mg once weekly injection). Other acceptable, less preferrable, options: liraglutide (Saxenda or Victoza), semaglutide tablet (Rybelsus), or lower dose of tirzepatide and semaglutide injections.
RECRUITING
Cleveland Clinic, Cleveland
NOT_YET_RECRUITING
Indiana University, Indianapolis
NOT_YET_RECRUITING
Mayo Clinic, Rochester
NOT_YET_RECRUITING
Banner Health Center, Phoenix
RECRUITING
Hospital Alemão Oswaldo Cruz, São Paulo
NOT_YET_RECRUITING
McGill University, Montreal
NOT_YET_RECRUITING
Turku University Hospital, Turku
NOT_YET_RECRUITING
Sri Aurobindo Institute of Medical Sciences, Indore
NOT_YET_RECRUITING
The Digestive Health Institute, Mumbai
NOT_YET_RECRUITING
University College Dublin, Dublin
NOT_YET_RECRUITING
Università Cattolica del Sacro Cuore, Milan
NOT_YET_RECRUITING
Sapienza Università di Roma, Roma
NOT_YET_RECRUITING
Kuwait University, Kuwait City
NOT_YET_RECRUITING
Instituto Nacional de Ciencias Médicas y Nutrición Salvador, Mexico City
NOT_YET_RECRUITING
Hospital Clínic Barcelona, Barcelona
NOT_YET_RECRUITING
Linköping University, Linköping
NOT_YET_RECRUITING
Örebro University, Örebro
NOT_YET_RECRUITING
Clarunis Universitäres, Basel
NOT_YET_RECRUITING
Hôpitaux universitaires de Genève, Geneva
NOT_YET_RECRUITING
Nuffield Health Bristol Hospital, Bristol
NOT_YET_RECRUITING
King's College Hospital, London
NOT_YET_RECRUITING
Queen Mary University, London
Sobia Laique, MD
UNKNOWN
Ali Aminian
OTHER