NCT02204163 is a Phase 3 clinical trial of Eutropin in Prader-Willi Syndrome, sponsored by LG Life Sciences.

Who is sponsoring NCT02204163?

NCT02204163 is sponsored by LG Life Sciences.

What drugs are being tested in NCT02204163?

Interventions in NCT02204163: Eutropin, Genotropin.

What condition does NCT02204163 study?

NCT02204163 studies Prader-Willi Syndrome.

Is NCT02204163 still recruiting?

NCT02204163 is currently completed. Last updated 24 June 2019.

Last reviewed 2019-06-24 · How we verify

NCT02204163

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase III, Multi-center, Randomized, Comparative, Parallel, Open Study to Assess the Efficacy and Safety After Treatment of Eutropin® Inj. Compared to Genotropin® in Infants/Toddlers With Prader-Willi Syndrome

Completed Phase 3 Last updated 24 June 2019

What this trial tests

Phase 3 trial testing Eutropin in Prader-Willi Syndrome in 34 participants. Completed in 1 December 2017.

Timeline

1 June 2014

Primary endpoint
1 December 2017

1 December 2017

Quick facts

Lead sponsor	LG Life Sciences
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	1 June 2014
Primary completion	1 December 2017
Estimated completion	1 December 2017
Sites	3 locations across South Korea

Drugs / interventions tested

Eutropin — full drug profile →
Genotropin

Conditions studied

Prader-Willi Syndrome — all drugs for Prader-Willi Syndrome →

Sponsor

LG Life Sciences — full company profile →

Who can join

Eligibility, any sex, with Prader-Willi Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change from baseline in height SDS (Standard Deviation Score)
Time frame: baseline and 52 weeks
Change from baseline in Lean body mass (g)
Time frame: baseline and 52 weeks
Change from baseline in Percent body fat (%)
Time frame: baseline and 52 weeks

Sponsor's own description

Evaluate the efficacy and safety after treatment of Eutropin® inj. compared to Genotropin® in infants/toddlers with Prader-Willi syndrome

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effects of recombinant human growth hormone treatment on growth, body composition, and safety in infants or toddlers with Prader-Willi syndrome: a randomized, active-controlled trial.
Yang A, Choi JH, Sohn YB, Eom Y, et al · · 2019 · cited 20× · PMID 31511031 · DOI 10.1186/s13023-019-1195-1

Verify or expand the search:

Other recruiting trials for Prader-Willi Syndrome

Currently open trials in the same condition.

NCT06877715 — Autistic Symptomatology and Sensory Profile in Children With Prader-Willi Syndrome · recruiting
NCT06772597 — A Study of Setmelanotide in Patients With Prader-Willi Syndrome · Phase 2 · active not recruiting
NCT06573723 — Institutional Registry of Rare Diseases · recruiting
NCT06239116 — A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment · Phase 1, PHASE2 · recruiting
NCT06144645 — A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS · Phase 3 · active not recruiting

Other LG Life Sciences trials

Trials by the same sponsor.

NCT02831361 — Trial to Evaluate the Efficacy and Safety of Gemigliptin Compared With Placebo Added on Insulin Alone or on Insulin in C · Phase 3 · completed
NCT03015909 — Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj. · Phase 4 · completed
NCT02746380 — A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy · Phase 3 · completed
NCT02290301 — An Observational Study to Evaluate Cardiovascular Outcomes of T2DM PatientsTreated With Gemigliptin · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02204163 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by LG Life Sciences
Last refreshed: 24 June 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02204163.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing