141-OR: Efficacy and Safety of Naltrexone/Bupropion as Add-On to Incretin Agents in Patients with Obesity and T2DM
Bibliographic record
Abstract
There is significant overlap between obesity and type 2 diabetes (T2DM). Incretin agents (dipeptidyl peptidase 4 (DPP-4) inhibitors and glucagon-like peptide 1 receptor agonists (GLP-1RAs)) are recommended as second-line to metformin in patients with T2DM due to their glucose-lowering effects, low risk of hypoglycemia, and favorable effect on weight. Naltrexone/bupropion (NB) is a combination therapy approved in North America and Europe for chronic weight management. This is an exploratory analysis of the efficacy and safety of NB in T2DM subjects enrolled in two double-blind, placebo-controlled Phase III studies (N=1344), that were stable on an incretin agent prior to randomization. At 1 year, mean weight change was -4.6% ± 0.21% in NB (N=700) compared to -1.1% ± 0.15% in placebo (N=644). In subjects randomized to NB that achieved at ≥5% weight loss at week 16 (early responders, N=269), mean weight change at 1 year was -8.8% ± 0.34%. An analysis of covariance using LOCF adjusting for age, sex, baseline BMI, baseline weight, and responder status revealed no significant interaction between incretin agent and weight treatment medication (p=0.1317), a significant treatment NB vs. placebo effect (p<0.0001), but not a significant incretin agent effect (p=0.1388). Safety and tolerability profiles were in line as previously observed in the broader population. In conclusion, NB is efficacious and safe in reducing weight in patients with obesity and T2DM on DPP-4 inhibitors and GLP-1RAs, and may be an effective addition when weight loss is a focus in treatment. Disclosure S. Wharton: Advisory Panel; Self; Bausch Health Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc. P. Yin: Employee; Self; Bausch Health. F. Camacho: Consultant; Self; Bausch + Lomb, Janssen Pharmaceuticals, Inc. M. Burrows: Employee; Self; Bausch Health. J. Blavignac: Employee; Self; Bausch Health Canada. M. Barakat: Employee; Self; Bausch Health.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
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".