Evaluation of Liraglutide 3.0mg in Patients With Poor Weight-loss and a Suboptimal Glucagon-like Peptide-1 Response

Sponsor
University College, London
Study ID
NCT03341429
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide Pen Injector [Saxenda] — DRUG
    Daily injection of GLP-1 agonist (liraglutide 3.0 mg) for obese patients presenting poor weight loss (\<20%) after bariatric surgery and suboptimal GLP-1 levels.
  • Placebo — DRUG
    Daily subcutaneous injection

Study Details

A double-blinded, randomised, placebo-controlled trial of liraglutide 3.0 mg in patients with poor weight-loss and a suboptimal glucagon-like peptide-1 response following bariatric surgery

Key Dates

Start date
Aug 22, 2018
Status verified
Nov 2020
Primary completion
Nov 28, 2019
Completion
Jun 11, 2020

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Daily subcutaneous injection of liraglutide 3.0 mg Study dosing of liraglutide: Week 1: 0.6 mg once daily Week 2: 1.2 mg once daily Week 3: 1.8 mg once daily Week 4: 2.4 mg once daily Week 5-24: 3.0 mg once daily In addition to the daily injection of liraglutide/placebo, participants in both groups will be advised to cut down approximately 500 calories from their usual food intake and to achieve a minimum of 150 minutes per week of physical activity.
  • Placebo Comparator: Control
    Daily subcutaneous injection of placebo; the same dosage regimen as treatment to be followed. In addition to the daily injection of liraglutide/placebo, participants in both groups will be advised to cut down approximately 500 calories from their usual food intake and to achieve a minimum of 150 minutes per week of physical activity.

Primary Outcome Measure

%WL [ Time Frame: 24 weeks ]

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