The goal of this clinical trial is to determine whether a semaglutide dose-tapering regimen is non-inferior to a treatment-dose maintenance regimen for weight-loss maintenance in adults with overweight or obesity who have achieved stable weight loss. This trial will also evaluate the safety of the dose-tapering regimen.
The primary research questions are:
Is the semaglutide dose-tapering regimen non-inferior to the treatment-dose maintenance regimen for weight-loss maintenance at 24 weeks? Can the dose-tapering regimen alleviate adverse events and offer a more personalized, sustainable pathway for medication discontinuation? Researchers will compare the semaglutide dose-tapering regimen against a treatment-dose maintenance regimen to assess whether the tapering strategy preserves weight loss and improves cardiometabolic markers.
Participants will:
Be randomly assigned to receive either the semaglutide dose-tapering regimen or the treatment-dose maintenance regimen for 24 weeks.
Complete a 24-week follow-up period after medication discontinuation (48 weeks total study duration).
Attend scheduled clinic visits for physical examinations and laboratory testing to assess weight, BMI, waist circumference, cardiometabolic markers (including blood glucose, blood pressure, and lipids), and to monitor adverse events.
Men and women, aged 18 to 64 years inclusive at the time of signing the informed consent form.
Ongoing weight-loss treatment consisting of weekly semaglutide, with a documented weight reduction of ≥ 10% of pre-treatment body weight, or a weight reduction between 5% and < 10% concurrent with a BMI < 25 kg/m².
Maintained on a weekly semaglutide dose of 1.7 mg, with a stable weight over the 12 weeks prior to enrollment (less than 5% change in body weight).
Voluntarily participating in the study, capable of effective communication with the investigators, willing to comply with all study procedures, and having provided written informed consent.
History or planned bariatric surgery or use of a weight-loss device during the trial.
Obesity induced by other endocrinologic disorders or monogenic mutations, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroidism, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism.
Glycated hemoglobin (HbA1c) ≥ 6.5% as measured by a local laboratory at screening, or a history of diabetes mellitus (excluding a history of gestational diabetes).
Use of any weight-loss medications (e.g., tirzepatide, mazdutide, liraglutide, orlistat, sibutramine, phenylpropanolamine, chlorpheniramine, phentermine, lorcaserin, phendimetrazine, phentermine-topiramate, or naltrexone-bupropion), herbal medicines, dietary supplements, or meal replacements affecting body weight within 90 days prior to screening (except semaglutide and lifestyle interventions). Use of medications that may cause significant weight gain, including systemic glucocorticoids for more than 1 week, antipsychotics or antiepileptics (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, clozapine, olanzapine, valproic acid and its derivatives, lithium preparations, thioridazine), or growth hormone.
Parallel
Semaglutide Dose-Tapering Regimen
DrugSemaglutide dose-tapering regimen: Subjects initiate from a stable entry dose of 1.7 mg per week, with a 25% relative dose reduction implemented every 8 weeks over the 24-week intervention period.
Semaglutide Maintenance-Dose Regimen
DrugSubjects keep the stable entry dose of 1.7 mg once-weekly without any dose modification during the full 24-week intervention period.
Percentage change in body weight from baseline to week 24
Body weight is measured with a calibrated medical electronic scale (accurate to 0.1 kg). Subjects are weighed in the morning after an overnight fast, post-voiding, barefoot, and wearing light clothing. Percentage change is calculated as \[(Week 24 body weight - baseline body weight) / baseline body weight\] × 100%.
Absolute change in body weight from baseline to week 24 (kg)
Measured using a calibrated medical electronic scale (accurate to 0.1 kg). Subjects will be weighed in the morning after an overnight fast, post-voiding, barefoot, and wearing light clothing. The absolute difference between baseline and week 24 body weight will be calculated.
Mean change in waist circumference from baseline to week 24 (cm)
Measured using a non-stretchable standard measuring tape (accurate to 0.1 cm). Waist circumference will be measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest in the mid-axillary line at the end of a normal expiration. The change from baseline is calculated.
Mean change in body mass index (BMI) from baseline to week 24 (kg/m²)
Height is measured using a standard stadiometer (accurate to 0.1 cm). Combined with the weight measured at the same timepoint, BMI is calculated using the formula: weight (kg) / height (m)².
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