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

Nanjing University

Status and phase: Completed; Phase 4

Conditions: Weight Loss; Bariatric Surgery; Obesity

Treatments: Drug: Liraglutide injection; Behavioral: Diet and exercise guidelines

Study type: Interventional

Funder types: Other

Identifiers

NCT07374445

2023-507-02

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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• Patients were discontinued if withdrawn, intolerant, lost to follow-up, or developed severe adverse events.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

control group

Sham Comparator group

Description:

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

Treatment:

Behavioral: Diet and exercise guidelines

Liraglutide 6 month group

Experimental group

Description:

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

Treatment:

Behavioral: Diet and exercise guidelines

Drug: Liraglutide injection

Liraglutide 9 month group

Experimental group

Description:

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

Treatment:

Behavioral: Diet and exercise guidelines

Drug: Liraglutide injection

Liraglutide 12 month group

Experimental group

Description:

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

Treatment:

Behavioral: Diet and exercise guidelines

Drug: Liraglutide injection