Norditropin FlexPro

DRUG4 trials

Sponsors

Novo Nordisk A/S, Ascendis Pharma Endocrinology Division A/S

Conditions

Children with short stature either born small for gestational age or with Turner syndromeGrowth Hormone Deficiency in childrenNoonan syndromeSGA - small for gestational age childrenTurner Syndrome (TS)idiopathic short stature (ISS)or idiopathic short statureshort stature homeobox containing gene deficiency (SHOX-D)

Phase 2

A dose-finding trial evaluating the effect and safety of once-weekly treatment of somapacitan compared to daily Norditropin® in children with short stature born small for gestational age with no catch-up growth by 2 years of age or older

Active, not recruitingCTIS2023-506830-66-00

Novo Nordisk A/SSGA - small for gestational age children

Start: 2019-05-29Target: 10Updated: 2025-10-29

Phase 3

A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency

CompletedCTIS2023-506829-11-00

Novo Nordisk A/SGrowth Hormone Deficiency in children

Start: 2019-05-29End: 2025-09-30Target: 22Updated: 2025-10-31

A study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design in children with short stature either born small for gestational age or with Turner syndrome, Noonan syndrome, or idiopathic short stature

Active, not recruitingCTIS2023-506927-27-00

Novo Nordisk A/SChildren with short stature either born small for gestational age or with Turner syndrome, Noonan syndrome, or idiopathic short stature

Start: 2022-08-29Target: 135Updated: 2025-10-27

HighLiGHts - A Pivotal, Parallel-Arm, Phase 3, Open-Label, Active-controlled, Global, Multicenter, Randomized Basket Trial Investigating the Efficacy and Safety of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Children and Adolescents with Growth Failure or Short Stature due to Growth Hormone Sufficient Disorders – Turner Syndrome, SHOX Deficiency, Small for Gestational Age, and Idiopathic Short Stature

Not yet recruitingCTIS2025-523079-44-00

Ascendis Pharma Endocrinology Division A/Sidiopathic short stature (ISS), short stature homeobox containing gene deficiency (SHOX-D), small for gestational age (SGA) +1

Target: 14Updated: 2026-02-27