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NCT07374445·Phase 4·INTERVENTIONAL

Research on Timing of Liraglutide Therapy in Patients With Obesity After Metabolic Surgery

Status

Completed

Phase

Phase 4

Enrollment

100

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

DRUG

Liraglutide injection

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.

BEHAVIORAL

Diet and exercise guidelines

Participants followed a science-based diet and exercise program intervention

Timeline

From registration to results.

  1. First posted

    Jan 28, 2026

  2. Study start

    Sep 1, 2023

  3. Primary completion

    Jun 1, 2025

  4. Study completion

    Jun 1, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Jan 28, 2026

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

Change in BMI from baseline to endpoint across patient groups

Time frame · 48 weeks from enrollment

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.

Change in body composition from baseline to endpoint across patient groups

Time frame · 48 weeks from enrollment

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.

Changes in blood pressure from baseline to endpoint

Time frame · 48 weeks from enrollment

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.

Changes in fasting blood glucose from baseline to endpoint

Time frame · 48 weeks from enrollment

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.

Change in HbA1c from baseline to endpoint across patient groups

Time frame · 48 weeks from enrollment

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Patients 6 months after metabolic surgery; * 18 years ≤ age ≤ 65 years; * Body Mass Index (BMI) ≥ 28 kg/m\^2 Exclusion Criteria: * 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.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Nanjing Drum Tower Hospital

Nanjing, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Liraglutide.

Related PeptideStat pages

Put the record in context.

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