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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss; Bariatric Surgery
• Intervention / Treatment: Behavioral: Diet and exercise guidelines; Drug: Liraglutide injection

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Nanjing, China
    • Nanjing Drum Tower Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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• Patients were discontinued if withdrawn, intolerant, lost to follow-up, or developed severe adverse events.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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: control group; Receive guidance on diet and exercise throughout the program, without the use of drugs	Behavioral: Diet and exercise guidelines; Participants followed a science-based diet and exercise program intervention
Experimental: Liraglutide 6 month group; Receive guidance on diet and exercise throughout the program, started pharmacological intervention at enrollment for 6 months.	Behavioral: Diet and exercise guidelines; Participants followed a science-based diet and exercise program intervention; 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.
Experimental: Liraglutide 9 month group; Receive guidance on diet and exercise throughout the program, started pharmacological intervention 6 months post 3 months of enrollment.	Behavioral: Diet and exercise guidelines; Participants followed a science-based diet and exercise program intervention; 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.
Experimental: Liraglutide 12 month group; Receive guidance on diet and exercise throughout the program, started pharmacological intervention 6 months post 6 months of enrollment.	Behavioral: Diet and exercise guidelines; Participants followed a science-based diet and exercise program intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 weeks from enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	48 weeks from enrollment

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: September 1, 2025
• First Submitted That Met QC Criteria: January 25, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: obesity; Liraglutide; bariatric surgery; BMI; GLP-1 receptor agonists
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Weight Loss; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Gastrointestinal Hormones; Glucagon-Like Peptides; Proglucagon; Glucagon-Like Peptide 1; Liraglutide; Diet
• Other Study ID Numbers: 2023-507-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No participant data are available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No