IGF-1 LR3 — safety
Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.
§4Safety
§4.1Adverse events reported in controlled trials
Table 4. Adverse events for IGF-1 LR3 as reported in the trial safety tables the Institute holds. Percentages are of randomised participants in the stated trial and arm.
| Event | Active, % | Comparator, % | Difference, pp | Source |
|---|---|---|---|---|
| Hypoglycaemia | — | — | — | The dominant expected risk, arising from insulin-receptor cross-reactivity combined with the absence of binding-protein buffering |
| Hypotension | — | — | — | Reported with native IGF-1 |
| Tissue growth effects | — | — | — | Theoretical; unbuffered IGF-1 receptor signalling is mitogenic |
| Jaw pain and Bell palsy | — | — | — | Reported with native recombinant IGF-1 in its approved indication |
| Tonsillar hypertrophy | — | — | — | Reported with native recombinant IGF-1 |
| A difference column is computed by the Institute from the two reported percentages and is not itself a published figure. Confidence intervals for adverse-event differences are not reported in the contributing trials and are not constructed here. | ||||
§4.2Contraindications
- Not established — no marketing authorisation for this analogue
- Active or suspected malignancy would be an absolute contraindication on mechanistic grounds
§4.3Warnings and precautions
- Hypoglycaemia is the principal acute risk and is potentiated by the absence of binding-protein buffering
- Unbuffered IGF-1 receptor agonism is mitogenic and the neoplasia concern is not theoretical in the same weak sense as for secretagogues
- No human safety data exist for this specific analogue at any dose
- Prohibited in competitive sport at all times
§4.4What this section does not establish
Related assessments: tolerability of incretin receptor agonists · acute pancreatitis · the rodent thyroid C-cell signal.[1,2]
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.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute
- United States Pharmacopeial Convention. General Chapter ⟨85⟩ Bacterial Endotoxins Test. United States Pharmacopeia — National Formulary (USP–NF) 2024;USP 2024 Issue 1. identifier not held by the Institute
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.