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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523079-44-00

Enrollment

Registered

2026-02-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic short stature (ISS), short stature homeobox containing gene deficiency (SHOX-D), small for gestational age (SGA), Turner Syndrome (TS)

Brief summary

Annualized height velocity (AHV) at Week 52

Detailed description

AHV (Week 104), Change from baseline in height SDS (CDC-based) (Weeks 52 and 104), Change from baseline in height SDS (condition specific if applicable) (Weeks 52 and 104), Treatment-emergent adverse events (AEs), Safety labs, vital signs, physical exam, local tolerability assessments, and fundoscopy, Bone age (Weeks 52 and 104), Bone age:chronological age ratio (Weeks 52 and 104)

Interventions

DRUGLonapegsomatropin

DRUGNorditropin FlexPro

DRUGinjektionsvæske

DRUGopløsning i fyldt pen

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Annualized height velocity (AHV) at Week 52	—

Secondary

Measure	Time frame
AHV (Week 104), Change from baseline in height SDS (CDC-based) (Weeks 52 and 104), Change from baseline in height SDS (condition specific if applicable) (Weeks 52 and 104), Treatment-emergent adverse events (AEs), Safety labs, vital signs, physical exam, local tolerability assessments, and fundoscopy, Bone age (Weeks 52 and 104), Bone age:chronological age ratio (Weeks 52 and 104)	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 28, 2026