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MGF Igf-1-ec

IGF-1Ec, IGF-1Eb, Mechano-Growth Factor

Quick Stats
Studies 62
Trials 100
Terminated PHASE2 INTERVENTIONAL NCT00572156

rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in response to another hormone called growth hormone. Growth Hormone is produced by a small gland at the base of the brain (the pituitary). Together IGF-1 and GH are large contributors to growth during infancy, childhood, and adolescence. Children with IGF Deficiency are short and have an imbalance in the levels of growth hormone and IGF-1 that their body produces. Their growth hormone levels are normal or even high, but IGF-1 levels do not increase normally in response to growth hormone. As a result, they have a type of growth hormone insensitivity and an inability to grow normally. This study is a test to see whether daily dosing with a combination of rhIGF-1 and rhGH will help children with IGFD grow taller more quickly than children treated with rhGH alone. The study medications, rhIGF-1 and rhGH, are approved by the US Food and Drug Administration (FDA) for use in some growth disorders in children, but the combination of rhIGF-1 and rhGH in children with IGF-1 deficiency (IGFD) is investigational.

Interventions

Name: NutropinAq® (Somatropin [rDNA origin])
Type: DRUG
Description: rhGH (Somatropin) 45µg/kg once daily injection
Name: Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])
Type: DRUG
Description: rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Name: Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])
Type: DRUG
Description: rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
Name: Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])
Type: DRUG
Description: rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections

Primary Outcomes

Measure: Height Velocity
TimeFrame: First year of treatment
Description:

Trial Information

NCT ID

NCT00572156

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Ipsen

Last Updated

December 15, 2025