Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity
ConditionSevere Obesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Friendship Hospital
About this trial
The SMART study is a 96-week, multicenter, randomized, double-blind, placebo-controlled superiority clinical trial. A total of 256 severe obesity patients are randomized 1:1 to either receive the bariatric surgery plus GCG/GLP-1 dual receptor agonist group (receiving sleeve gastrectomy followed by subcutaneous injections of mazdutide weekly, with stepwise dose escalation to a maintenance dose per protocol) or the bariatric surgery plus placebo group (receiving matched procedure plus placebo injections). The primary objective is to evaluate the potential enhancing weight reduction effects of the combination therapy with bariatric surgery and mazdutide measured by the percentage change of excess weight loss.
Eligibility criteria
Qualifiers
Aged 18-70 years (inclusive), male or female;
BMI≥37.5 kg/m2, with or without obesity-related complications;
Planned to take sleeve gastrectomy
Understand the trial protocol, voluntarily sign the informed consent form (ICF), and agree to follow all study requirements and restrictions.
Disqualifiers
Previous gastrointestinal surgery such as stomach and duodenum, or weight loss and metabolic surgery;
History of thyroid C-cell carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B, or relevant family history;
ALT > 3.0 × ULN (if NAFLD is diagnosed at screening and within 6 months prior to screening, ALT ≤ 5.0 × ULN can be enrolled), or AST > 3.0 ×ULN, or total bilirubin (TBIL) > 2 × ULN
Estimated glomerular filtration rate eGFR < 45 mL/min/1.73 m2 using the CKD-EPI equation
Trial design
Treatments tested in this trial
- Sleeve gastrectomy plus early mazdutide initiation
- Sleeve gastrectomy followed with early mazdutide placebo initation
Treatment groups
256 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov