MOD-4023

DRUG7 trials

Conditions

Adult Growth Hormone DeficiencyGrowth Hormone DeficiencyGrowth Hormone Deficiency (GHD)Pediatric Growth Hormone Deficiency

Phase 1

Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers

CompletedNCT02418767

OPKO Health, Inc.Growth Hormone Deficiency

Start: 2015-01-31End: 2015-06-30Updated: 2019-09-30

Phase 2

MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA)

CompletedNCT01225666

OPKO Health, Inc.Adult Growth Hormone Deficiency

Start: 2010-08-31End: 2012-04-30Updated: 2019-10-08

Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

CompletedNCT01592500

OPKO Health, Inc.Pediatric Growth Hormone Deficiency

Start: 2012-02-29End: 2015-07-31Updated: 2020-01-23

Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

CompletedNCT02500316

OPKO Health, Inc.Growth Hormone Deficiency (GHD)

Start: 2014-02-28End: 2023-11-30Updated: 2025-04-09

Phase 3

A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency

TerminatedNCT01909479

OPKO Health, Inc.Adult Growth Hormone Deficiency

Start: 2013-06-30End: 2018-08-31Updated: 2022-08-12

Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

CompletedNCT02968004

OPKO Health, Inc.Pediatric Growth Hormone Deficiency

Start: 2016-12-31End: 2024-05-31Updated: 2025-07-20

Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency

CompletedNCT03874013

OPKO Health, Inc.Growth Hormone Deficiency

Start: 2017-12-07End: 2020-03-06Updated: 2021-08-12

The Journal of Clinical Endocrinology & Metabolism2026-06-29

Extension of the Phase 3 Trial of Somatrogon in Children with Growth Hormone Deficiency: 3 Years of Safety and Efficacy

Hormone Research in Paediatrics2026-06-01

Efficacy and safety of once-weekly somatrogon in adults with growth hormone deficiency: a randomized phase 3 study

Pituitary2026-03-25

Efficacy and safety of once-weekly somatrogon following up to 4 years of treatment in Japanese children with growth hormone deficiency: results from an open-label extension of a phase 3 study.

2025-10-31

<i>Post hoc</i> subgroup analysis of Asian children with paediatric GHD from the global phase 3 efficacy and safety study of once-weekly somatrogon vs. once-daily somatropin

Journal of Pediatric Endocrinology and Metabolism2024-05-081 citations

2024-01-247 citations

Physician experience with once-weekly somatrogon versus once-daily rhGH regimen in pediatric patients with growth hormone deficiency: a cross-sectional survey of physicians from the global phase 3 study

Frontiers in Endocrinology2023-10-179 citations

OR21-04 Long-term Efficacy And Safety Of Once-weekly Somatrogon In Pediatric Subjects With Growth Hormone Deficiency: Results From Up To 8 Years Of Somatrogon Treatment

Journal of the Endocrine Society2023-10-013 citations

THU170 Clinical And Immunological Response To Somatrogon In Two Siblings With A Homozygous Whole Gene Deletion Of The Growth Hormone 1 Gene

Journal of the Endocrine Society2023-10-01

RF26 | PSAT150 Growth Outcomes From the Phase 2 and Phase 3 Studies of Once Weekly Somatrogon vs Daily Genotropin in Pediatric Patients With Growth Hormone Deficiency: Comparisons With Published Literature and an International Growth Study Database

Journal of the Endocrine Society2022-11-01

PMON329 Survey of physician experience with once weekly somatrogon vs once daily somatropin regimen for the treatment of pediatric patients with growth hormone deficiency: results from a cross sectional, observational study

Journal of the Endocrine Society2022-11-01

Efficacy and Safety of Weekly Somatrogon vs Daily Somatropin in Children With Growth Hormone Deficiency: A Phase 3 Study

The Journal of Clinical Endocrinology & Metabolism2022-04-1184 citations

Efficacy and Safety of Once-Weekly Somatrogon Compared with Once-Daily Somatropin (Genotropin®) in Japanese Children with Pediatric Growth Hormone Deficiency: Results from a Randomized Phase 3 Study

Hormone Research in Paediatrics2022-01-0127 citations

Comparison of Quality of Life Responses From Caregiver and Children Aged ≥7 Years Using the Quality of Life in Short Stature Youth (QoLISSY) Questionnaire, Following 12 Months of Growth Hormone Treatment With Either a Weekly Somatrogon or a Daily Genotropin Injection Schedule

Journal of the Endocrine Society2021-05-017 citations

Switch Data From the Open-Label Extension of the Pivotal Phase 3 Study of Once Weekly Somatrogon Compared to Daily Somatropin in Pediatric Patients With Growth Hormone Deficiency (pGHD)

Journal of the Endocrine Society2021-05-015 citations

Results From an Open-Label Extension of the Phase 2 Dose Finding Study of Once Weekly Somatrogon vs Daily Genotropin in Pediatric Patients With Growth Hormone Deficiency (GHD)

Journal of the Endocrine Society2021-05-013 citations

Phase 3 Study Evaluating Once Weekly Somatrogon Compared to Daily Genotropin in Japanese Patients With Pediatric Growth Hormone Deficiency (pGHD)

Journal of the Endocrine Society2021-05-012 citations

OR10-06 Somatrogon Growth Hormone in the Treatment of Pediatric Growth Hormone Deficiency: Results of the Pivotal Pediatric Phase 3 Clinical Trial

Journal of the Endocrine Society2020-04-018 citations

MOD-4023

Sponsors

Conditions

Phase 1

Phase 2

Phase 3

Related Papers