ObesityPhase 4NCT07163650
Evaluating Anti-Obesity Medications 6 Months After Metabolic Surgery
A Phase 4 study testing Efsubaglutide Alfa Injection and Diet and exercise guidelines in people with Obesity and Weight Loss, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This clinical trial aims to evaluate the weight-loss efficacy and safety of efsubaglutide alfa in patients who remain obese 6 months after metabolic surgery. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obesity, Weight Loss, Metabolic Surgery
- What is being tested?
- Efsubaglutide Alfa Injection and Diet and exercise guidelines
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2025to 28 Feb 2027
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 6 months after metabolic surgery
- 18 years ≤ age ≤ 55 years
- Body Mass Index (BMI) ≥ 28 kg/m^2
- Voluntarily sign the informed consent form and agree to strictly adhere to the requirements and restrictions outlined in the informed consent form and this protocol throughout the entire study period.
Who cannot join
- Subjects suspected by the investigator of having a potential allergy to the study drug or its components, or those with a history of allergic constitution;
- Use of any of the following drugs or treatments prior to screening:
- ● Glucagon-like peptide-1 (GLP-1R) agonists within 3 months prior to screening
- ● Use within 3 months prior to screening of any weight-affecting medications, including systemic corticosteroids, metformin, sodium-glucose cotransporter 2 (SGLT2) inhibitors, etc.;
- ● Use of weight-affecting herbal supplements, health products, or meal replacements within 3 months prior to screening;
- Use of weight-loss medications within 3 months prior to screening or currently using such medications, e.g., sibutramine hydrochloride, orlistat, phentermine, etc.;
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- Participation in other clinical trials (receiving investigational drug treatment) within 3 months prior to screening.
- ③ History or evidence of any of the following conditions prior to screening:
- History of depression; or history of severe psychiatric disorders such as schizophrenia, bipolar disorder, etc.;
- Uncontrolled hypertension at screening despite at least 4 weeks of antihypertensive medication, defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg;
- History of malignancy at screening;
- History of cardiac disease at screening: acute myocardial infarction, unstable angina, post-coronary artery bypass grafting, post-percutaneous coronary intervention, severe arrhythmia;
- Hemorrhagic or ischemic stroke, or transient ischemic attack within 6 months prior to screening;
- History or family history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) type 2A or 2B at screening;
- History of acute or chronic pancreatitis, or pancreatic injury at screening;
- Presence of limb deformities or amputations preventing accurate measurement of height, weight, or other anthropometric parameters;
- Major or moderate surgery, severe trauma, or severe infection within 1 month prior to screening, deemed unsuitable for study participation by the investigator;
- History of suicidal tendencies or suicide attempts;
- Anticipated surgery during the study period;
- Participants testing positive for HIV antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or syphilis antibodies at screening;
- History of alcohol abuse within 1 month prior to screening, defined as average weekly alcohol intake exceeding 21 units for males or 14 units for females; ④ Presents clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening: - Second- or third-degree atrioventricular block - Long QT syndrome or QTcF > 450 ms - PR interval < 120 ms or PR interval > 220 ms - QRS > 120 ms QRS duration >120ms, left or right bundle branch block, Wolff-Parkinson-White syndrome, or other severe arrhythmias requiring treatment;
- History of other risk factors for torsades de pointes, such as hypokalemia at screening, family history of long QT syndrome, or concomitant use of QT/QTc-prolonging medications at screening; ⑥ Blood donation volume and/or blood loss ≥400 mL within 3 months prior to screening, or hemoglobin <110 g/L (males) or <100 g/L (females); ⑦ Presence of any other factors deemed by the investigator to potentially affect the efficacy or safety evaluation of this study, rendering the subject unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
zhaoqun Chu, +86-25-83106666, kejiaochu-2001@163.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of Efsubaglutide Alfa in Patients Remaining Obese 6 Months After Metabolic Surgery
This clinical trial aims to evaluate the weight-loss efficacy and safety of efsubaglutide alfa in patients who remain obese 6 months after metabolic surgery.
Read the detailed description
This study investigates the effects of efsubaglutide alfa intervention in patients with a body mass index (BMI) ≥28 kg/m² six months after metabolic surgery, aiming to determine whether it facilitates weight normalization and remission of obesity-related comorbidities, thereby assessing the weight-loss and metabolic benefits of early efsubaglutide alfa application in post-metabolic surgery obesity management.
- Conditions
- Obesity, Weight Loss, Metabolic Surgery
- Being tested
- Efsubaglutide Alfa Injection, Diet and exercise guidelines
- Keywords
- obesity, BMI, GLP-1 receptor agonist, Efsubaglutide Alfa, Metabolic surgery
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efsubaglutide Alfa InjectionDrug
Also called Drug injection
Efsubaglutide Alfa was injected daily in the morning before meals Subcutaneous injection at a dose of 1 mg/week in the first two weeks, increased to 3 mg/week in week 3, increased to 6 mg/week in week 5, up to 9 mg/2 week in week 13.
Diet and exercise guidelinesBehavioural
Also called Lifestyle guidelines
Participants followed a science-based diet and exercise program intervention.
| Study group | Role | What they receive |
|---|---|---|
| Efsubaglutide Alfa group | Experimental | Receive guidance on diet and exercise throughout the program, started pharmacological intervention at enrollment for 24 weeks. Receives: Drug: Efsubaglutide Alfa Injection; Behavioral: Diet and exercise guidelines |
| control group | Sham comparator | Receive guidance on diet and exercise throughout the program, without the use of drugs. Receives: Behavioral: Diet and exercise guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in %TWL from baseline to endpoint
%TWL = ([baseline weight - weight at follow-up]/baseline weight) × 100%. The measurement of body weight is in kilograms. %TWL represents the percentage of total weight loss, measured in percent. This indicator reflects the percentage of weight loss from the baseline. The mean and standard deviation of %TWL were calculated for subjects within each group. Subsequently, intergroup comparisons were performed to calculate p-values. If p < 0.05, pairwise comparisons were further conducted. Based on the final results, the differences in weight loss among groups were evaluated.
Measured: 24 weeks from enrollment
Secondary outcomes (7)
Proportion of patients with different %TWL levels
%TWL = ([baseline weight - weight at follow-up]/baseline weight) × 100%. The measurement of body weight is in kilograms. %TWL represents the percentage of total weight loss, measured in percent. This indicator reflects the proportion of patients achieving clinically meaningful %TWL thresholds (≥ 5%, ≥ 10%, ≥ 15%, and ≥ 20%). Then perform intergroup comparison to calculate the p-value and assess the weight loss difference between the two groups.
Measured: 24 weeks from enrollment
Proportion of patients with normal weight and overweight
BMI = Weight / Height^2 Weight is measured in kilograms, height in meters, and BMI is expressed in kilograms per square meter. This indicator reflects percentage of patients with normal weight (BMI<24kg/m2) and overweight (BMI <28kg/m2) from baseline after intervention. Then perform intergroup comparison to calculate the p-value and assess the difference between the two groups.
Measured: 24 weeks from enrollment
Change in body composition from baseline to endpoint across patient groups
Body composition (Including body fat, fat-free mass, skeletal muscle, etc.; in kilograms） Body composition values at the endpoint minus baseline values are used as the change metric to evaluate body composition changes (These indicators are used to assess the body composition improvement of patients) Complete data correction for each patient using baseline values, then calculate overall mean and SD by group. Subsequently perform intergroup comparisons to compute P-values; if P < 0.05, proceed with pairwise comparisons.
Measured: 24 weeks from enrollment
Remission Status of Obesity-Related Diseases
Obesity-Related Diseases include: Diabetes Mellitus, Hypertension, Fatty Liver Disease, Hyperlipidemia and Hyperuricemia.
Remission status was assessed based on the incidence of complications in patients at baseline and endpoint. Then perform intergroup comparison to calculate the p-value and assess the differences in disease remission between the two groups.
Measured: 24 weeks from enrollment
Changes in blood pressure from baseline to endpoint
Difference between the endpoint blood pressure and the baseline value.(blood pressure in mmHg; This indicator is used to assess improvements in a patient's blood pressure.) Complete data correction for each patient using baseline values, then calculate overall mean and SD by group. Subsequently perform intergroup comparisons to compute P-values; if P < 0.05, proceed with pairwise comparisons.
Measured: 24 weeks from enrollment
Changes in fasting blood glucose from baseline to endpoint
Difference between endpoint fasting blood glucose and baseline value (blood glucose in mmol/L; This indicator is used to assess improvements in patients' fasting blood glucose levels.) Complete data correction for each patient using baseline values, then calculate overall mean and SD by group. Subsequently perform intergroup comparisons to compute P-values; if P < 0.05, proceed with pairwise comparisons.
Measured: 24 weeks from enrollment
Change in HbA1c from baseline to endpoint across patient groups
Difference between the endpoint HbA1c value and the baseline value (HbA1c in percentage, This indicator is used to assess improvements in a patient's HbA1c levels.) Complete data correction for each patient using baseline values, then calculate overall mean and SD by group. Subsequently perform intergroup comparisons to compute P-values; if P < 0.05, proceed with pairwise comparisons.
Measured: 24 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start16 Sep 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenhuan W Feng, MD, Study chair, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163650
- Sponsor's protocol ID
- 2025-0631-01
- Status last verified
- Aug 2025
- First submitted
- 1 Sep 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No participant data are available
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of Efsubaglutide Alfa in Patients Remaining Obese 6 Months After Metabolic Surgery
- ClinicalTrials.gov ID
- NCT07163650
- Acronym / sponsor ID
- 2025-0631-01
- Conditions
- Obesity, Weight Loss, Metabolic Surgery
- Keywords
- obesity, BMI, GLP-1 receptor agonist, Efsubaglutide Alfa, Metabolic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 9 Sep 2025 (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.
This clinical trial aims to evaluate the weight-loss efficacy and safety of efsubaglutide alfa in patients who remain obese 6 months after metabolic surgery.
Detailed description
This study investigates the effects of efsubaglutide alfa intervention in patients with a body mass index (BMI) ≥28 kg/m² six months after metabolic surgery, aiming to determine whether it facilitates weight normalization and remission of obesity-related comorbidities, thereby assessing the weight-loss and metabolic benefits of early efsubaglutide alfa application in post-metabolic surgery obesity management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efsubaglutide Alfa group | Experimental | Drug: Efsubaglutide Alfa Injection, Behavioral: Diet and exercise guidelinesReceive guidance on diet and exercise throughout the program, started pharmacological intervention at enrollment for 24 weeks. |
| control group | Sham comparator | Behavioral: Diet and exercise guidelinesReceive guidance on diet and exercise throughout the program, without the use of drugs. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 6 months after metabolic surgery
- 18 years ≤ age ≤ 55 years
- Body Mass Index (BMI) ≥ 28 kg/m^2
- Voluntarily sign the informed consent form and agree to strictly adhere to the requirements and restrictions outlined in the informed consent form and this protocol throughout the entire study period.
Key exclusion criteria (22 listed)
- Subjects suspected by the investigator of having a potential allergy to the study drug or its components, or those with a history of allergic constitution;
- ● Glucagon-like peptide-1 (GLP-1R) agonists within 3 months prior to screening
- ● Use within 3 months prior to screening of any weight-affecting medications, including systemic corticosteroids, metformin, sodium-glucose cotransporter 2 (SGLT2) inhibitors, etc.;
- ● Use of weight-affecting herbal supplements, health products, or meal replacements within 3 months prior to screening;
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 |
|---|---|---|
| Efsubaglutide Alfa InjectionAlso: Drug injectionEfsubaglutide Alfa was injected daily in the morning before meals Subcutaneous injection at a dose of 1 mg/week in the first two weeks, increased to 3 mg/week in week 3, increased to 6 mg/week in week 5, up to 9 mg/2 week in week 13. | Drug | Efsubaglutide Alfa group |
| Diet and exercise guidelinesAlso: Lifestyle guidelinesParticipants followed a science-based diet and exercise program intervention. | Behavioural | Efsubaglutide Alfa group, control group |
Primary outcome
Change in %TWL from baseline to endpoint
Time frame: 24 weeks from enrollment
%TWL = ([baseline weight - weight at follow-up]/baseline weight) × 100%. The measurement of body weight is in kilograms. %TWL represents the percentage of total weight loss, measured in percent. This indicator reflects the percentage of weight loss from the baseline. The mean and standard deviation of %TWL were calculated for subjects within each group. Subsequently, intergroup comparisons were performed to calculate p-values. If p < 0.05, pairwise comparisons were further conducted. Based on the final results, the differences in weight loss among groups were evaluated.
7 secondary outcomes
Proportion of patients with different %TWL levels
Time frame: 24 weeks from enrollment
Proportion of patients with normal weight and overweight
Time frame: 24 weeks from enrollment
Change in body composition from baseline to endpoint across patient groups
Time frame: 24 weeks from enrollment
Remission Status of Obesity-Related Diseases
Time frame: 24 weeks from enrollment
Changes in blood pressure from baseline to endpoint
Time frame: 24 weeks from enrollment
Changes in fasting blood glucose from baseline to endpoint
Time frame: 24 weeks from enrollment
Change in HbA1c from baseline to endpoint across patient groups
Time frame: 24 weeks from enrollment
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 27 Jan 2026.
- Individual participant dataSharing planned: No. No participant data are available
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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.
Wenhuan W Feng, MD study chair
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Efsubaglutide Alfa Injection and Diet and exercise guidelines in people with Obesity and Weight Loss, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
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 22 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: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 wenhuan Feng (+86-25-83106666, fengwh501@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in %TWL from baseline to endpoint (time frame: 24 weeks from enrollment). 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 27 Jan 2026.