Obesity & OverweightPhase 4NCT07783854
A Randomized Controlled Study of Dose-tapering Regimen of Semaglutide for Weight-Loss Maintenance in Adults With Overweight or Obesity
A Phase 4 study testing Semaglutide Dose-Tapering Regimen and Semaglutide Maintenance-Dose Regimen in people with Obesity & Overweight, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Semaglutide Dose-Tapering Regimen and Semaglutide Maintenance-Dose Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- History of acute or chronic pancreatitis, or presence of high-risk factors such as a history of pancreatic injury. Current or past history of malignancies (except for localized basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the prostate). Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2, including MEN 2A and MEN 2B).
- End-stage renal disease, or requiring long-term/intermittent hemodialysis or peritoneal dialysis.
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- Occurrence of any of the following within 60 days prior to screening: myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack (TIA).
- Current New York Heart Association (NYHA) class IV heart failure.
- Known or suspected hypersensitivity to the investigational product or related products.
- Participation in another clinical trial within 90 days prior to screening.
- Female patients who are pregnant, breastfeeding, or planning to become pregnant within the next two years.
- History of major depressive disorder or a diagnosis of other severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) within 2 years prior to screening.
- History of attempted suicide.
- Abnormal laboratory results at screening: severe hepatic or renal impairment, such as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × upper limit of normal (ULN); bilirubin > 2.5 × ULN (except for known Gilbert's syndrome meeting the criteria of fractionated conjugated bilirubin < 35% of total bilirubin); triglycerides ≥ 5.7 mmol/L.
- Unstable proliferative retinopathy or maculopathy requiring urgent treatment within 1 year prior to screening, or a history of diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, or severe metabolic disorders leading to neurological or psychiatric dysfunction.
- History or risk factors of the following: clinically significant anemia, epilepsy, syncope, cardiac arrest, arrhythmia, atrioventricular block, structural heart disease, or torsades de pointes.
- Severe active bacterial, viral, or fungal infections requiring hospitalization or intravenous antibiotic therapy.
- History of infectious diseases, including but not limited to HIV/AIDS, syphilis, or active infectious hepatitis.
- History of alcohol dependence or substance abuse within 6 months prior to screening.
- Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of a Semaglutide Dose-Tapering Regimen for Weight-Loss Maintenance in Adults With Overweight or Obesity: A Randomized, Non-Inferiority, Open-Label Clinical Study
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:
Read more
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.
- Conditions
- Obesity & Overweight
- Being tested
- Semaglutide Dose-Tapering Regimen, Semaglutide Maintenance-Dose Regimen
- Keywords
- Semaglutide, Weight loss maintenance, Dose-tapering, Obesity
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide Dose-Tapering RegimenDrug
Semaglutide 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 RegimenDrug
Subjects keep the stable entry dose of 1.7 mg once-weekly without any dose modification during the full 24-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Dose-tapering Group | Experimental | Participants receive a semaglutide dose-tapering regimen, starting from their stable entry dose of 1.7 mg/week. A 25% dose reduction is implemented every 8 weeks until the end of week 24. Receives: Drug: Semaglutide Dose-Tapering Regimen |
| Maintenance-dose Group | Active comparator | Participants maintain their original stable entry regimen of semaglutide 1.7 mg once weekly throughout the 24-week intervention period, with no dose adjustments performed. Receives: Drug: Semaglutide Maintenance-Dose Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Baseline (Week 0) to Week 24
Secondary outcomes (3)
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.
Measured: Baseline (Week 0) to Week 24
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.
Measured: Baseline (Week 0) to Week 24
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.
Measured: Baseline (Week 0) to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783854
- Sponsor's protocol ID
- UHCT260719
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Semaglutide Dose-Tapering Regimen for Weight-Loss Maintenance in Adults With Overweight or Obesity: A Randomized, Non-Inferiority, Open-Label Clinical Study
- ClinicalTrials.gov ID
- NCT07783854
- Acronym / sponsor ID
- UHCT260719
- Conditions
- Obesity & Overweight
- Keywords
- Semaglutide, Weight loss maintenance, Dose-tapering, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose-tapering Group | Experimental | Drug: Semaglutide Dose-Tapering RegimenParticipants receive a semaglutide dose-tapering regimen, starting from their stable entry dose of 1.7 mg/week. A 25% dose reduction is implemented every 8 weeks until the end of week 24. |
| Maintenance-dose Group | Active comparator | Drug: Semaglutide Maintenance-Dose RegimenParticipants maintain their original stable entry regimen of semaglutide 1.7 mg once weekly throughout the 24-week intervention period, with no dose adjustments performed. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
- History of acute or chronic pancreatitis, or presence of high-risk factors such as a history of pancreatic injury. Current or past history of malignancies (except for localized basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the prostate). Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2, including MEN 2A and MEN 2B).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide Dose-Tapering RegimenSemaglutide 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. | Drug | Dose-tapering Group |
| Semaglutide Maintenance-Dose RegimenSubjects keep the stable entry dose of 1.7 mg once-weekly without any dose modification during the full 24-week intervention period. | Drug | Maintenance-dose Group |
Primary outcome
Percentage change in body weight from baseline to week 24
Time frame: Baseline (Week 0) 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%.
3 secondary outcomes
Absolute change in body weight from baseline to week 24 (kg)
Time frame: Baseline (Week 0) to Week 24
Mean change in waist circumference from baseline to week 24 (cm)
Time frame: Baseline (Week 0) to Week 24
Mean change in body mass index (BMI) from baseline to week 24 (kg/m²)
Time frame: Baseline (Week 0) to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide Dose-Tapering Regimen and Semaglutide Maintenance-Dose Regimen in people with Obesity & Overweight, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunfei Liao, PhD (+86 15972021280, yunfeiliao2012@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in body weight from baseline to week 24 (time frame: Baseline (Week 0) to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.