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

NCT07374445 | Completed Phase 4

• 1 other identifier: 2023-507-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. \[primary hypothesis 2\] 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

Keywords

Liraglutide; bariatric surgery; obesity; BMI; GLP-1 receptor agonists

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in BMI from baseline to endpoint across patient groups

  48 weeks from enrollment

• Change in body composition from baseline to endpoint across patient groups

  48 weeks from enrollment

• Changes in blood pressure from baseline to endpoint

  48 weeks from enrollment

• Changes in fasting blood glucose from baseline to endpoint

  48 weeks from enrollment

• Change in HbA1c from baseline to endpoint across patient groups

  48 weeks from enrollment

Study Arms (4)

control group

SHAM COMPARATOR

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

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.

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.

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.

Drug: Liraglutide injection; Behavioral: Diet and exercise guidelines

Interventions

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.

Liraglutide 12 month group; Liraglutide 6 month group; Liraglutide 9 month group

Diet and exercise guidelines BEHAVIORAL

Participants followed a science-based diet and exercise program intervention

Liraglutide 12 month group; Liraglutide 6 month group; Liraglutide 9 month group; control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 6 months after metabolic surgery;
• years ≤ age ≤ 65 years;
• Body Mass Index (BMI) ≥ 28 kg/m\^2

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, China

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Liraglutide; Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: January 28, 2026
• Study Start: September 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 28, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)