AOD-9604 in knee osteoarthritis with obesity — evidence extract
The Institute's graded assessment of AOD-9604 for knee osteoarthritis with obesity, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Knee osteoarthritis with obesity
§1.1Question and anchor outcome
- Population
- Degenerative joint disease of the knee with radiographic or symptomatic confirmation, occurring with obesity as a mechanical and inflammatory contributor.
- Intervention
- AOD-9604, oral in the clinical programme; subcutaneous in research contexts
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- WOMAC pain subscale
Additional outcomes the Institute extracts for this indication: Physical function score; Analgesic use; Progression to arthroplasty.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of AOD-9604 in knee osteoarthritis with obesity.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| AOD-OA-PH2 | 2 | Randomised, double-blind, placebo-controlled | — | 12 weeks | 2015 |
§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 | No concern | No serious concern identified in this domain. |
| Indirectness | Serious | An outcome that would answer the question was not measured in any contributing trial. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | Serious | Registered trials without posted results were identified for this question. |
| 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.
- Heffernan M, Summers RJ, Thorburn A, Ogru E, Gianello R, Jiang WJ, Ng FM. The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and β3-AR knock-out mice. Endocrinology 2001;142(12):5182–5189. doi:10.1210/endo.142.12.8522 · PMID 11713213
- Thevis M, Thomas A, Schänzer W. Detecting peptidic drugs, drug candidates and analogs in sports doping: current status and future directions. Expert Review of Proteomics 2019;11(6):663–673. doi:10.1586/14789450.2014.965158
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.