Obesity

Characterization of the effect of naltrexone/bupropion on body composition

Diabetes Obes MetabPublished Secondary analysis of the COR-I randomised trial

Authors' conclusion

NB-induced weight loss is associated with significant reductions in total percent fat mass, increase in total percent lean mass, and change in lean-to-fat mass ratio, in comparison to placebo. Larger studies are needed to further elucidate the clinical significance of these changes and impact of a potentially healthier metabolism.

Study context

Population
Subgroup of COR-I phase 3 trial participants with body composition assessed by DXA; comparable baseline age, BMI, sex
Participants
82 participants
Comparison
Naltrexone/bupropion vs placebo
  • Naltrexone/bupropion (NB)n = 56
  • Placebon = 26reference
Primary endpoint
Changes in total, lean and fat mass by DXA
Follow-up
Baseline to week 52
Methodological detailssubgroup with DXA, placebo-controlled, phase 3
  • Subgroup with DXA
  • Placebo-controlled
  • Phase 3

Primary result

As reported in the abstract

Change in total mass · week 52
GroupValueFat mass changeLean mass change
NB−7.8%−12.9%−4.1%
Placebo−2.8%−4.8%−1.4%

Value

NB−7.8%
Placebo−2.8%

Fat mass change

NB−12.9%
Placebo−4.8%

Lean mass change

NB−4.1%
Placebo−1.4%

Further findings

OutcomeNBPlaceboP value
Adjusted change in lean-to-fat mass ratio · week 52Adjusted for baseline covariates0.069−0.056P < 0.05

Original publication

Characterization of the effect of naltrexone/bupropion on body composition. Diabetes Obes Metab. Published 10 February 2025. doi:10.1111/dom.16235

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