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Randomized controlled trial

SCALE Obesity and Prediabetes: liraglutide 3.0 mg (Saxenda)

With liraglutide 3.0 mg daily, plus diet and exercise, participants lost an average of 8.4 kg at 56 weeks, compared with 2.8 kg on placebo; the difference was −5.6 kg (95% CI, −6.0 to −5.1).

Pi-Sunyer X et al. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. New England Journal of Medicine, 2015. DOI: 10.1056/NEJMoa1411892

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Key facts

Drug
liraglutide
Design
Randomized controlled trial
Participants
3,731
Duration
56 weeks
Funding
Novo Nordisk
Registry
NCT01272219
Population
3,731 adults without type 2 diabetes with a BMI of 30 or more (or 27 or more with dyslipidemia or hypertension); 61.2% had prediabetes and mean starting weight was 106.2 kg.
Primary outcome
Change in weight, proportion losing at least 5% and proportion losing more than 10% at 56 weeks.

What it found

Mean weight loss, % of starting weight · 56 weeks
  • Liraglutide 3.0 mg daily−8.0%
  • Placebo−2.6%

Difference: −5.4 points vs placebo (95% CI, −5.8 to −5.0).

Figures from the EU labelSee the results in a chart

With liraglutide 3.0 mg daily, plus diet and exercise, participants lost an average of 8.4 kg at 56 weeks, compared with 2.8 kg on placebo; the difference was −5.6 kg (95% CI, −6.0 to −5.1). Of those on liraglutide, 63.2% lost at least 5% of their weight, compared with 27.1% on placebo, and 33.1% lost more than 10%, compared with 10.6%. The most common adverse effects were mild or moderate nausea and diarrhea; serious events occurred in 6.2% on liraglutide and 5.0% on placebo.

Limitations

Funded by Novo Nordisk. Missing data were imputed with the last observation carried forward, a method now considered not very conservative. Weight loss is smaller than that later seen with semaglutide and tirzepatide, although they were not compared directly.

What it means for you

With daily liraglutide (Saxenda), the average loss was 8.4 kg versus 2.8 kg on placebo over 56 weeks. Figures from different trials cannot be compared directly, because the population and the design change. If you are interested in this drug, your doctor can explain how it fits your case.

Further reading

Related trials

  • liraglutide56 weeks

    SCALE Maintenance

    After losing 6.0% on the diet, weight fell by a further 6.2% with liraglutide and 0.2% with placebo between randomization and week 56.

  • liraglutide104 weeks

    S-LiTE (off-treatment follow-up)

    One year after treatment ended, those who had received exercise plus liraglutide weighed 5.1 kg less and had a body fat percentage 2.3 points lower than those who had received liraglutide alone.

  • semaglutide and liraglutide68 weeks

    STEP 8

    At 68 weeks, weight changed by −15.8% with semaglutide and −6.4% with liraglutide.

  • orforglipron52 weeks

    ATTAIN-MAINTAIN

    On orforglipron, 74.7% of the weight lost on tirzepatide was maintained, versus 49.2% on placebo.

Sources

The original paper and the records consulted for this summary, with the date they were accessed.

  1. New England Journal of Medicine.Pi-Sunyer X, et al. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015;373(1):11-22.accessed .
  2. National Library of Medicine (PubMed).PubMed record PMID 26132939 (abstract).accessed .