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

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study ID
NCT07374445
Phase
PHASE4
Status
Completed

Conditions

  • Bariatric Surgery
  • Obesity
  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • Diet and exercise guidelines — BEHAVIORAL
    Participants followed a science-based diet and exercise program intervention

Study Details

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

Key Dates

Start date
Sep 1, 2023
Status verified
May 2025
Primary completion
Jun 1, 2025
Completion
Jun 1, 2025

Study Design

Enrollment
100 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

Change in %TWL from baseline to endpoint across patient groups [ Time Frame: 48 weeks from enrollment ]

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