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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Sleeve gastrectomy plus early mazdutide initiation

    Drug

    After sleeve gastrectomy is preformed, mazdutide injection (pre-filled auto-injector pen) is administered subcutaneously at the same time each week at 5th month post procedure. The treatment begins with a starting dose of 2.0 mg, followed by a titration schedule increasing by 2.0 mg every 4 weeks (2.0 mg → 4.0 mg). If well-tolerated, participants reached the target maintenance dose of 6.0 mg (4.0 mg → 6.0 mg)weekly for maintenance. The protocol permits adaptive dose downgrade to 4.0 mg weekly when clinically indicated, such as intolerance. The total intervention is maintained until 48 weeks post procedure.

  • Sleeve gastrectomy followed with early mazdutide placebo initation

    Drug

    After sleeve gastrectomy is preformed, mazdutide placebo injection (pre-filled auto-injector pen) is administered subcutaneously at the same time each week at 5th month post procedure. The treatment begins with a starting dose of 2.0 mg placebo, followed by a titration schedule increasing by 2.0 mg every 4 weeks (2.0 mg → 4.0 mg). If well-tolerated, participants reached the target maintenance dose of 6.0 mg placebo(4.0 mg → 6.0 mg) weekly for maintenance. The protocol permits adaptive dose downgrade to 4.0 mg weekly when clinically indicated, such as intolerance. The total intervention is maintained until 48 weeks post procedure.

Treatment groups

256 Participants
are divided into 2 treatment groups
Group A: Sleeve gastrectomy plus mazdutide groupExperimental treatment 1 intervention
Group B: Sleeve gastrectomy plus mazdutide placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

the rate of excess weight loss(EWL%) compared to baseline

EWL%=\[preoperative weight-post operative weight\]/\[preoperative weight -ideal body weight\]x100%, ideal weight=height²(m²)x25kg/m²

Time frame
At 48th week post procedure

Secondary outcomes

1

Assessing the change in BMI(kilogram/square meter, kg/m²） classification compared to baseline(Based on the BMI classification in Chinese adiposity diagnosis and treatment guideline 2024)

BMI classification in China: BMI 18.5-24 kg/m² healthy; 24\<BMI\<28 kg/m² overweight, 28\<BMI\<32.5 kg/m² mild obesity, 32.5\<BMI\<37.5 kg/m² moderately obese, BMI\>37.5 kg/m² severe or extremely severe obesity

Time frame
At 48th week post procedure
2

Assessing the rate of total body weight loss(TBWL%) compared to baseline

Total body weight loss (TBWL) is the pre-op weight minus the post op body weight

Time frame
At 48th week post procedure
3

Assessing the change of waist circumference(centimeter, cm) compared to baseline

waist circumference is measured with centimeter(cm)

Time frame
at 48th week post procedure
4

Assessing the change of hip circumference(centimeter, cm) compared to baseline

Hip circumference is measured with centimeter(cm).

Time frame
At 48th week post procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov

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