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A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management (SCALE Obesity)

Pi-Sunyer X, Astrup A, Fujioka K, et al.

New England Journal of Medicine/2015/3,731 participants/56 weeks
Key Finding

Liraglutide 3.0 mg daily produced a mean weight loss of 8.4% versus 2.8% with placebo in adults with obesity, leading to FDA approval of Saxenda.

Background

Prior to semaglutide 2.4 mg, liraglutide 3.0 mg (Saxenda) was the most effective pharmacological option for obesity management. The SCALE (Satiety and Clinical Adiposity — Liraglutide Evidence) program evaluated a higher dose of liraglutide than used for diabetes (1.2–1.8 mg) specifically for weight management.

Methods

Phase 3, double-blind, randomized, placebo-controlled trial at 191 sites in 27 countries. Adults with BMI ≥30 (or ≥27 with comorbidities) without type 2 diabetes. Liraglutide 3.0 mg or placebo, plus lifestyle intervention.

Primary endpoints: weight loss ≥5%, mean weight change, sustained weight loss (loss ≥5% at week 12 maintained through week 56).

Key Findings

OutcomeLiraglutide 3.0 mgPlacebo
Mean weight loss8.4%2.8%
≥5% weight loss63.2%27.1%
≥10% weight loss33.1%10.6%
Waist circumference−8.2 cm−4.0 cm
Blood pressure improvementSig. reduction

Clinical Significance

SCALE Obesity provided the pivotal evidence for FDA approval of liraglutide 3.0 mg (Saxenda) in December 2014 for chronic weight management. It was the first GLP-1 agonist approved specifically for obesity, establishing this drug class as a viable pharmacotherapy.

Though subsequently surpassed by semaglutide 2.4 mg in efficacy, liraglutide remains widely used and represents the proof-of-concept for GLP-1 agonism in obesity treatment.

Limitations

  • Requires daily injection (vs. weekly for semaglutide/tirzepatide)
  • Weight loss magnitude substantially lower than later agents
  • GI side effects led to 9.9% discontinuation vs. 4.3% placebo

Compounds Studied

Related Conditions

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