A Study to Investigate Efficacy and Safety of Weekly PEG-somatropin (GenSci004) in Treatment Naive Children With Growth Hormone Deficiency

The Efficacy and Safety of Once-weekly PEG-somatropin (GenSci004) in Treatment-naive Children With Growth Hormone Deficiency: A Randomized, Open-label, Parallel-group, Active-Controlled, Non-inferiority Phase 3 Study (ELEVATE)

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06007417

Acronym

ELEVATE

Enrollment

162

Registered

2023-08-23

Start date

2023-12-01

Completion date

2025-08-01

Last updated

2023-09-11

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

Conditions

GHD

Keywords

GHD, growth hormone deficiency

Brief summary

The purpose of this study is to evaluate the efficacy and safety of weekly GenSci004 compared with daily Genotropin in treatment-naive children with growth failure due to GHD.

Detailed description

The purpose of this Phase 3 study is to evaluate the efficacy, safety, and tolerability of weekly GenSci004 compared to daily Genotropin over 52 weeks in prepubertal treatment-naïve children with growth failure due to GHD.

Interventions

DRUGGenSci004

GenSci004 is a pegylated rhGH (PEG rhGH) (i.e., PEG-somatropin)

DRUGGenotropin

Genotropin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

Healthy volunteers

Inclusion criteria

1. Prepubertal children with GHD in Tanner Stage 1 2. Baseline HT at least -2.0 SD below the mean HT for CA and sex (HT SDS ≤ 2.0). 3. Body mass index (BMI) within ±2.0 SD of the mean BMI for BA and sex. 4. Growth hormone stimulation tests: ≤10 ng/mL 5. Baseline IGF 1 level of at least 1.0 SD below the mean IGF 1 level standardized for age and sex (IGF 1 SDS ≤-1.0) 6. Normal 46 XX karyotype for girls. 7. Children with multiple hormonal deficiencies must be on stable replacement therapy for other hypothalamo-pituitary axes for at least 3 months 8. Written, signed informed consent of the parent(s) or legal guardian(s) of the participant and written assent of the participant

Exclusion criteria

1. BA≥CA 2. Prior exposure to rhGH, long-acting growth hormones, or IGF 1 therapy. 3. Major medical conditions or presence of contraindication to human growth hormone (hGH) treatment 4. Participation in any other trial of an investigational agent within 3 months prior to Screening. 5. Any reason per investigator's discretion

Design outcomes

Primary

Measure	Time frame	Description
Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups	52 weeks	Measured in centimeter per year (cm/year)

Secondary

Measure	Time frame	Description
Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups	104 weeks	Measured in centimeter per year (cm/year)

Countries

United States

Contacts

Primary ContactPeng Duan

info@gensci-china.com+86-431-85195060

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026