IGF-1 LR3 in growth hormone deficiency and growth-hormone secretagogue pharmacology — evidence extract
The Institute's graded assessment of IGF-1 LR3 for growth hormone deficiency and growth-hormone secretagogue pharmacology, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Growth hormone deficiency and growth-hormone secretagogue pharmacology
§1.1Question and anchor outcome
- Population
- Insufficient endogenous growth-hormone secretion, or the pharmacological stimulation of the growth-hormone axis, assessed here principally through provocative testing and IGF-1 response.
- Intervention
- IGF-1 LR3, subcutaneous in research contexts
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Peak stimulated growth hormone
Additional outcomes the Institute extracts for this indication: Change in IGF-1 and IGFBP-3; Body composition by DXA; Glucose tolerance.
§1.2Contributing trials
No trial has been identified for IGF-1 LR3 in growth hormone deficiency and growth-hormone secretagogue pharmacology. The rating below reflects that absence.
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | Very serious | The primary endpoint is patient-reported in a setting where blinding cannot be maintained. |
| Inconsistency | Serious | Too few contributing studies to assess consistency formally. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: Very low certainty. The Institute has very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate. In this series a very low rating most often reflects an absence of controlled human evidence rather than conflicting evidence. | ||
§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.
- 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
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. 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.