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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT07374445 (opens ClinicalTrials.gov in a new tab)Other id2023-507-02
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
100 participants (actual)
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

China

Start
1 Sept 2023
Primary completion
1 Jun 2025
Completion
1 Jun 2025
First posted
28 Jan 2026
Last update posted
28 Jan 2026
Conditions
Obesity · Weight Loss · Bariatric Surgery

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 4

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

    NCT07374445

    1 Sept 2023 to 1 Jun 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • Liraglutide injectionDrug
  • Diet and exercise guidelinesBehavioral

Arms4

  • Sham comparator

    control group

    Receive guidance on diet and exercise throughout the program, without the use of drugs

  • Experimental

    Liraglutide 6 month group

    Receive guidance on diet and exercise throughout the program, started pharmacological intervention at enrollment for 6 months.

  • Experimental

    Liraglutide 9 month group

    Receive guidance on diet and exercise throughout the program, started pharmacological intervention 6 months post 3 months of enrollment.

  • Experimental

    Liraglutide 12 month group

    Receive guidance on diet and exercise throughout the program, started pharmacological intervention 6 months post 6 months of enrollment.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in %TWL from baseline to endpoint across patient groups

    Time frame · 48 weeks from enrollment

    Registry description

    %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(5)

  1. Change in BMI from baseline to endpoint across patient groups

    Time frame · 48 weeks from enrollment

    Registry description

    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.

  2. Change in body composition from baseline to endpoint across patient groups

    Time frame · 48 weeks from enrollment

    Registry description

    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.

  3. Changes in blood pressure from baseline to endpoint

    Time frame · 48 weeks from enrollment

    Registry description

    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.

  4. Changes in fasting blood glucose from baseline to endpoint

    Time frame · 48 weeks from enrollment

    Registry description

    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.

  5. Change in HbA1c from baseline to endpoint across patient groups

    Time frame · 48 weeks from enrollment

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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