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Completed

NCT Number: NCT07374445

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

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

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Key information

Conditions

Obesity Bariatric Surgery Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nanjing Drum Tower Hospital

Nanjing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Patients were discontinued if withdrawn, intolerant, lost to follow-up, or developed severe adverse events.

Treatment and study plan

Liraglutide injection

Drug

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 guidelines

Behavioral

Participants followed a science-based diet and exercise program intervention

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

The Timing for Liraglutide in Patients Remaining Obese at 6 Months After Metabolic Surgery: an Observational Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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