Assessing the effects of naltrexone‐bupropion on hepatic steatosis and fibrosis in patients with T2DM and overweight or obesity: Insights from a placebo‐controlled trial
Authors' conclusion
Weight loss was the key driver of hepatic improvements in patients with T2DM and overweight or obesity. Treatment with NB resulted in significantly greater weight reduction and significantly greater improvements in HSI and MAF-5 compared with placebo, suggesting an added benefit for liver health.
Study context
- Population
- Adults with T2DM and overweight or obesityrandomized 2:1
- Participants
- 505 adults
- Comparison
- Naltrexone/bupropion vs placebo, both with lifestyle counselling
- Primary endpoint
- Change in hepatic steatosis and fibrosis risk by non-invasive indices (HSI, MAF-5, FIB-4)
- Follow-up
- Week 56
Methodological details56-week, double-blind, placebo-controlled, randomized 2:1, structured lifestyle counselling in both arms
- 56-week
- Double-blind
- Placebo-controlled
- Randomized 2:1
- Structured lifestyle counselling in both arms
Primary result
As reported in the abstract
Change in HSI, MAF-5 and FIB-4
- FIB-4 scores remained unchanged in both groups
- Naltrexone/bupropion (NB) vs Placebo: P < 0.001
- NB vs Placebo: P = 0.003
- Post hoc analysis
Further findings
| Outcome | NB | Placebo | P value |
|---|---|---|---|
| Body weight change · Week 56 | −6.3 ± 7.2 kg | −2.5 ± 5.2 kg | P < 0.001 |
Hepatic Steatosis Index (HSI) and MAF-5 by weight loss strata
- Best improvements in HSI and MAF-5 with ≥5% or ≥10% vs <5% weight loss
- all p < 0.001
Correlation of weight change with hepatic indices
- Weight change vs HSI reduction
- r = 0.796, p < 0.001
- Weight change vs MAF-5
- r = 0.488, p < 0.001
- Weight change vs FIB-4
- r = 0.034, p = 0.590
Predictors of hepatic improvement (multiple regression)
- Weight change was the strongest predictor of improvements in HSI, MAF-5, ALT and AST; no significant contributions from other factors
Original publication
Assessing the effects of naltrexone‐bupropion on hepatic steatosis and fibrosis in patients with T2DM and overweight or obesity: Insights from a placebo‐controlled trial. Diabetes Obes Metab. Published 2 September 2025. doi:10.
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