Extended‐release naltrexone/bupropion and liver health: Pooled, post hoc analysis from four randomized controlled trials
Bibliographic record
Abstract
Abstract Sustained weight loss improves liver histology in non‐alcoholic fatty liver disease. This post hoc analysis of four phase III, 56‐week, randomized controlled trials investigated if extended‐release naltrexone and bupropion (NB) affects alanine aminotransferase (ALT) and Fibrosis‐4 (FIB‐4) index in adults with overweight or obesity. Two thousand and seventy‐three subjects (NB = 1310; placebo = 763; 79.0% female; 81.6% Caucasian) had baseline mean weight 101 kg, body mass index 36.2 kg/m 2 , ALT 26.9 IU/L and FIB‐4 0.79. At 56 weeks, NB‐treated subjects experienced more weight loss than placebo (8.7 vs. 3.2 kg, respectively, P < .0001). Weight loss, independent of treatment, was associated with improved ALT and FIB‐4 ( P < .0001). There was a significant independent effect of NB on change from baseline for FIB‐4 ( P < .0001), but not for ALT ( P = .54). Categorical ALT response (from above to within normal ranges: 10‐40 IU/L for men; 7‐35 IU/L for women) and achievement of 25% and 50% reduction in ALT were greater for NB versus placebo, and independently affected by weight loss ( P < .0001), but not treatment. NB‐associated weight loss may improve liver health by normalizing ALT values for those with high baseline levels.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.016 | 0.018 |
| Meta-epidemiology (narrow) | 0.004 | 0.001 |
| Meta-epidemiology (broad) | 0.013 | 0.022 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".