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Mod GRF 1-29

Sermorelin, Growth Hormone Releasing Hormone (1-29), hGRF(1-29)NH2

Quick Stats
Studies 227
Trials 47
Completed OBSERVATIONAL NCT01088412

Observational Study of Somatropin Treatment in Children

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

GeNeSIS is an open-label, multinational, multicenter, observational study to evaluate the safety and effectiveness of Humatrope treatment. GeNeSIS is a modular program that includes: * Core study: Evaluating the safety and effectiveness of Humatrope in the observational setting * Genetic Analysis Sub-study: Investigating the genetic defects underlying growth hormone (GH) deficiency and non-GH-deficient growth disorders * Growth Prediction Sub-study: Working to validate and refine specific models to accurately predict growth response to GH * Short Stature Homeobox containing gene (SHOX) Deficiency Sub-study: Elucidating the clinical, endocrine and radiological features of participants with SHOX deficiency due to loss of, or mutation in the SHOX gene (including participants with Turner syndrome) * Neoplasia Sub-study: To characterize the natural history of neoplastic disease, especially in relation to recurrence/progression of primary neoplasia or development of secondary neoplasia in children with a history of neoplasia

Interventions

Name: Somatropin (recombinant deoxyribonucleic acid [rDNA] origin)
Type: DRUG
Description: Dose, frequency and duration at discretion of attending physician.

Primary Outcomes

Measure: Type 2 Diabetes Mellitus in GH-treated Participants
TimeFrame: Year 15
Description:
Measure: Primary Malignancies in Participant Without Previous Cancer History
TimeFrame: Year 15
Description: Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated.
Measure: Final Height (FH) Gain by Diagnostic Group
TimeFrame: Baseline through Year 15
Description: The standard deviation score (SDS) reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height. Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated.

Trial Information

NCT ID

NCT01088412

Status

Completed

Study Type

OBSERVATIONAL

Sponsor

Eli Lilly and Company

Last Updated

December 15, 2025

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