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Liraglutide 2011-06-01 ClinicalTrials

Liraglutide 3.0 mg induces significant weight loss and delays type 2 diabetes onset in non-diabetic obese subjects

Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes

Background

Obesity and its associated co-morbidities, including pre-diabetes and increased risk of type 2 diabetes (T2D), represent a major global health challenge. Current weight management strategies often fall short in achieving sustained weight loss and preventing disease progression. Glucagon-like peptide-1 (GLP-1) receptor agonists like liraglutide offer a promising pharmacological approach by modulating appetite, satiety, and glucose homeostasis, thereby addressing key physiological drivers of weight gain and metabolic dysfunction. This trial builds on established GLP-1R agonism to provide a robust, long-term solution.

Study Design

This multi-center, randomized clinical trial evaluated liraglutide 3.0 mg administered once daily subcutaneously. Subjects were non-diabetic obese or overweight individuals with co-morbidities, including those with pre-diabetes. A 12-week low-calorie diet run-in period preceded randomization. Subjects who achieved ≥5% screening body weight loss were randomized to treatment for either 56 weeks (followed by a 12-week re-randomized period) or 160 weeks (for pre-diabetic subjects). Primary endpoints included weight loss induction and maintenance, and delaying T2D onset.

Results

While this specific trial aims to further evaluate and confirm long-term outcomes, previous findings from the broader SCALE program, which established liraglutide 3.0 mg for obesity management, demonstrated significant efficacy. > Patients without diabetes achieved a mean weight loss of 8% at 56 weeks with liraglutide 3.0 mg compared to 2% with placebo. This substantial difference highlights the potent weight-reducing effects of GLP-1R agonism. The trial specifically aims to investigate the long-term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline, building upon the known metabolic benefits of GLP-1 activation, such as improved insulin sensitivity and pancreatic beta-cell function. The extended 160-week treatment duration for pre-diabetic subjects underscores the focus on chronic disease prevention.


Source: clinicaltrials:NCT01272219 · Ingested 2026-06-09 · Digest: gemini-2.5-flash