ObesityPhase 4NCT07374445
Research on Timing of Liraglutide Therapy in Patients With Obesity After Metabolic Surgery
A Phase 4 study testing Liraglutide 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
The goal of this clinical trial is to compare the weight loss and metabolic benefit in patients remaining obesity at 6 months after metabolic surgery. The main questions it aims to answer are: [primary hypothesis 1] Whether liraglutide benefits weight loss when it is initiated early after metabolic surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Weight Loss, Bariatric Surgery
- What is being tested?
- Liraglutide 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
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 6 months after metabolic surgery;
- 18 years ≤ age ≤ 65 years;
- Body Mass Index (BMI) ≥ 28 kg/m^2
Who cannot join
- allergy to liraglutide, severe hepatic or renal impairment (eGFR <60 mL/min/1.73 m² or ALT/AST ≥3× ULN)
- history of medullary thyroid carcinoma, MEN-2 or other malignancies
- pancreatitis or severe gastrointestinal disease, pregnancy or lactation
- use of anti-obesity drugs or other interventional trials within 3 months or major uncontrolled illness
- Patients were discontinued if withdrawn, intolerant, lost to follow-up, or developed severe adverse events.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Timing for Liraglutide in Patients Remaining Obese at 6 Months After Metabolic Surgery: an Observational Study
The goal of this clinical trial is to compare the weight loss and metabolic benefit in patients remaining obesity at 6 months after metabolic surgery. The main questions it aims to answer are:
[primary hypothesis 1] Whether liraglutide benefits weight loss when it is initiated early after metabolic surgery.
[primary hypothesis 2] Whether weight loss and metabolic benefits are greater when linaglutide is initiated in patients who are obese at 6 months after metabolic surgery
- Conditions
- Obesity, Weight Loss, Bariatric Surgery
- Being tested
- Liraglutide injection, Diet and exercise guidelines
- Keywords
- Liraglutide, bariatric surgery, obesity, BMI, GLP-1 receptor agonists
- 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.
Liraglutide injectionDrug
Patients received a 24-week regimen of once-daily liraglutide, initiated at 0.6 mg/day and titrated weekly by 0.6 mg to a maximum tolerated dose of up to 3.0 mg/day.
Diet and exercise guidelinesBehavioural
Participants followed a science-based diet and exercise program intervention
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | Receive guidance on diet and exercise throughout the program, without the use of drugs Receives: Behavioral: Diet and exercise guidelines |
| Liraglutide 6 month group | Experimental | Receive guidance on diet and exercise throughout the program, started pharmacological intervention at enrollment for 6 months. Receives: Drug: Liraglutide injection; Behavioral: Diet and exercise guidelines |
| Liraglutide 9 month group | Experimental | Receive guidance on diet and exercise throughout the program, started pharmacological intervention 6 months post 3 months of enrollment. Receives: Drug: Liraglutide injection; Behavioral: Diet and exercise guidelines |
| Liraglutide 12 month group | Experimental | Receive guidance on diet and exercise throughout the program, started pharmacological intervention 6 months post 6 months of enrollment. Receives: Drug: Liraglutide injection; 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 across patient groups
%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: 48 weeks from enrollment
Secondary outcomes (5)
Change in BMI from baseline to endpoint across patient groups
BMI = Weight / Height^2 weight and height will be combined to report BMI in kg/m^2 (Weight is measured in kilograms, height in meters, and BMI is expressed in kilograms per square meter) The observed metric is the difference obtained by subtracting the endpoint BMI from the baseline BMI.
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: 48 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: 48 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: 48 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: 48 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: 48 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 posted28 Jan 2026
- Study start1 Sep 2023
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374445
- Sponsor's protocol ID
- 2023-507-02
- Status last verified
- May 2025
- First submitted
- 1 Sep 2025
- Last updated
- 28 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Timing for Liraglutide in Patients Remaining Obese at 6 Months After Metabolic Surgery: an Observational Study
- ClinicalTrials.gov ID
- NCT07374445
- Acronym / sponsor ID
- 2023-507-02
- Conditions
- Obesity, Weight Loss, Bariatric Surgery
- Keywords
- Liraglutide, bariatric surgery, obesity, BMI, GLP-1 receptor agonists
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 28 Jan 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 compare the weight loss and metabolic benefit in patients remaining obesity at 6 months after metabolic surgery. The main questions it aims to answer are:
[primary hypothesis 1] Whether liraglutide benefits weight loss when it is initiated early after metabolic surgery.
[primary hypothesis 2] Whether weight loss and metabolic benefits are greater when linaglutide is initiated in patients who are obese at 6 months after metabolic surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Behavioral: Diet and exercise guidelinesReceive guidance on diet and exercise throughout the program, without the use of drugs |
| Liraglutide 6 month group | Experimental | Drug: Liraglutide injection, Behavioral: Diet and exercise guidelinesReceive guidance on diet and exercise throughout the program, started pharmacological intervention at enrollment for 6 months. |
| Liraglutide 9 month group | Experimental | Drug: Liraglutide injection, Behavioral: Diet and exercise guidelinesReceive guidance on diet and exercise throughout the program, started pharmacological intervention 6 months post 3 months of enrollment. |
| Liraglutide 12 month group | Experimental | Drug: Liraglutide injection, Behavioral: Diet and exercise guidelinesReceive guidance on diet and exercise throughout the program, started pharmacological intervention 6 months post 6 months of enrollment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 6 months after metabolic surgery;
- 18 years ≤ age ≤ 65 years;
- Body Mass Index (BMI) ≥ 28 kg/m^2
Key exclusion criteria (5 listed)
- allergy to liraglutide, severe hepatic or renal impairment (eGFR <60 mL/min/1.73 m² or ALT/AST ≥3× ULN)
- history of medullary thyroid carcinoma, MEN-2 or other malignancies
- pancreatitis or severe gastrointestinal disease, pregnancy or lactation
- use of anti-obesity drugs or other interventional trials within 3 months or major uncontrolled illness
- Patients were discontinued if withdrawn, intolerant, lost to follow-up, or developed severe adverse events.
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 |
|---|---|---|
| Liraglutide injectionPatients received a 24-week regimen of once-daily liraglutide, initiated at 0.6 mg/day and titrated weekly by 0.6 mg to a maximum tolerated dose of up to 3.0 mg/day. | Drug | Liraglutide 12 month group, Liraglutide 6 month group, Liraglutide 9 month group |
| Diet and exercise guidelinesParticipants followed a science-based diet and exercise program intervention | Behavioural | Liraglutide 12 month group, Liraglutide 6 month group, Liraglutide 9 month group, control group |
Primary outcome
Change in %TWL from baseline to endpoint across patient groups
Time frame: 48 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.
5 secondary outcomes
Change in BMI from baseline to endpoint across patient groups
Time frame: 48 weeks from enrollment
Change in body composition from baseline to endpoint across patient groups
Time frame: 48 weeks from enrollment
Changes in blood pressure from baseline to endpoint
Time frame: 48 weeks from enrollment
Changes in fasting blood glucose from baseline to endpoint
Time frame: 48 weeks from enrollment
Change in HbA1c from baseline to endpoint across patient groups
Time frame: 48 weeks from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Liraglutide 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 28 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in %TWL from baseline to endpoint across patient groups (time frame: 48 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 28 Jan 2026.