PMID-23812094 – SCALE Maintenance Liraglutide Weight Maintenance After Diet
Wadden TA, Hollander P, Klein S, Niswender K, Woo V, Hale PM, Aronne L; NN8022-1923 Investigators. Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: the SCALE Maintenance randomized study. Int J Obes (Lond). 2013;37(11):1443-51.
Quick Reference
| Property | Value |
|---|---|
| PMID | 23812094 |
| DOI | 10.1038/ijo.2013.120 |
| Year | 2013 |
| Journal | International Journal of Obesity |
| Study Type | Randomized Controlled Trial (Multicenter, Double-Blind, Placebo-Controlled) |
| Evidence Level | II |
| Sample | n=422 adults (BMI 30-40) who had lost >=5% body weight via LCD run-in |
| Peptide(s) Studied | Liraglutide |
Key Findings
- Primary endpoint (additional weight loss at 56 weeks): Liraglutide 3.0 mg group lost an additional -6.2% body weight vs -0.2% for placebo from randomization (p<0.0001) — this was on top of the -6.0% already lost during the low-calorie diet run-in
- Total weight loss from screening: Liraglutide group achieved -12.2% total body weight loss (LCD run-in + 56-week treatment) vs -6.2% for placebo
- Weight maintenance: 81.4% of liraglutide-treated patients maintained the initial diet-induced weight loss (>=5%) vs 48.9% of placebo patients at 56 weeks
- >=5% additional weight loss (from randomization): 50.5% liraglutide vs 21.8% placebo (p<0.001)
- >=10% additional weight loss: 26.1% liraglutide vs 6.3% placebo (p<0.001)
- Cardiometabolic improvements: Significant reductions in HbA1c, fasting glucose, fasting insulin, systolic and diastolic blood pressure, and hsCRP with liraglutide vs placebo
- Waist circumference: Additional -6.9 cm with liraglutide vs -3.4 cm with placebo from randomization
- Adverse events: Nausea (48% vs 17%), diarrhea (17% vs 10%), and constipation (17% vs 6%) were the most frequent AEs with liraglutide; mostly mild-to-moderate and transient
Study Design
Phase II, multicenter (36 sites in US, Canada, Europe), double-blind, placebo-controlled RCT with a 4-12 week low-calorie diet (1,200 kcal/day) run-in period. Patients who lost >=5% body weight during the run-in (n=422 of 674 enrolled) were randomized 1:1 to liraglutide 3.0 mg/day SC or placebo for 56 weeks, combined with a 500 kcal/day deficit diet and exercise (>=150 min/week). The study design uniquely addressed the clinical scenario of maintaining and extending weight loss after an initial dietary intervention.
Limitations
- Relatively small sample size (n=422 randomized) compared to later SCALE trials
- Selection bias from the LCD run-in — only patients who successfully lost >=5% (63%) were randomized, potentially enriching for more motivated/responsive patients
- Phase II study — dose optimization was still ongoing
- Single-dose tested (3.0 mg) — no dose comparison arms
- 56-week treatment duration — long-term weight maintenance beyond 1 year not assessed
- Post-treatment weight regain expected based on class effects but not formally studied in follow-up
Clinical Relevance
SCALE Maintenance addresses a critical gap in obesity medicine: the well-documented challenge of maintaining diet-induced weight loss. The study demonstrates that liraglutide 3.0 mg not only prevents weight regain but promotes additional weight loss when added after successful dietary intervention. The -12.2% total weight loss (diet + liraglutide) approaches the magnitude achieved with bariatric endoscopy procedures and has significant metabolic impact. This "sequential approach" (diet first, then pharmacotherapy) may be particularly practical for clinical settings where structured dietary programs are already in place. The study informed the clinical rationale for combining lifestyle intervention with GLP-1 RA pharmacotherapy that now underpins modern obesity treatment algorithms.
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#research #RCT #liraglutide #evidence-level-II #metabolic