Tesamorelin in metabolic dysfunction-associated steatohepatitis — evidence extract
The Institute's graded assessment of Tesamorelin for metabolic dysfunction-associated steatohepatitis, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Metabolic dysfunction-associated steatohepatitis
§1.1Question and anchor outcome
- Population
- Steatotic liver disease with histological evidence of hepatocyte ballooning and lobular inflammation occurring in the context of at least one cardiometabolic risk factor. Formerly termed non-alcoholic steatohepatitis.
- Intervention
- Tesamorelin, subcutaneous once daily
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Resolution of steatohepatitis without worsening of fibrosis
Additional outcomes the Institute extracts for this indication: Improvement of fibrosis by ≥1 stage without worsening of steatohepatitis; Change in liver stiffness by vibration-controlled transient elastography; Change in ALT.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Tesamorelin in metabolic dysfunction-associated steatohepatitis.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| TESA-NAFLD-PH2 | 2 | Randomised, double-blind, placebo-controlled | 61 | 12 months | 2019 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | Serious | Too few contributing studies to assess consistency formally. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | Serious | The event count falls below the optimal information size. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: Low certainty. Confidence in the effect estimate is limited. The true effect may be substantially different from the estimate. | ||
§1.4What this extract does not establish
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
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- Teichman SL, Neale A, Lawrence B, Gagnon C, Castaigne JP, Frohman LA. Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults. Journal of Clinical Endocrinology & Metabolism 2006;91(3):799–805. doi:10.1210/jc.2005-1536 · PMID 16352683
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