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Clinical Trials

We are driven by science and data

Medical research is critical to drive innovation and scientific advancements that can improve patients’ lives – our mission at Ascendis Pharma. Clinical trials are a fundamental step in this process to develop new therapeutics. As a science-based company, we are committed to conducting clinical trials with the utmost quality and respect for both the clinical trial participants and the scientific hypothesis being evaluated.

We have three endocrinology rare disease product candidates — TransCon™ hGH, TransCon PTH and TransCon CNP – in clinical development. In oncology, we are evaluating a portfolio of product candidates.

Explore below for more about our clinical programs.

ACHONDROPLASIA

Trial: ACcomplisH Trial

ACcomplisH: A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled, Dose Escalation Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Subcutaneous Doses of TransCon CNP Administered Once Weekly for 12 months in Prepubertal Children with Achondroplasia

Phase: 2

Status: Ongoing

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Trial: ACHieve Study

ACHieve: A Multi-center, Longitudinal, Observational Study of Children With Achondroplasia

Phase: Non-interventional (no medication will be given in this study)

Status: Ongoing

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HYPOPARATHYROIDISM

Trial: PaTHway Trial

PaTHway: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism

Phase: 3

Status: Ongoing

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Trial: PaTH Forward Trial

PaTH Forward: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism

Phase: 2

Status: Ongoing

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GROWTH HORMONE DEFICIENCY

Trial: foresiGHt Trial

foresiGHt: A Multicenter, Randomized, Parallel-arm, Placebo-controlled (Double-blind) and Active-controlled (Open-label) Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin with Placebo and a Daily Somatropin Product in Adults with Growth Hormone Deficiency

Phase: 3

Status: Ongoing

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Trial: riGHt Trial

riGHt : A Multicenter, Phase 3, Randomized, Open-label, Active controlled, Parallel-group Trial Investigating the Efficacy, Safety, and Tolerability of Lonapegsomatropin (TransCon hGH) administered Once a Week Versus Standard Daily hGH Replacement Therapy Over 52 Weeks in Japanese Prepubertal hGH-treatment Naïve Children with Growth Hormone Deficiency (GHD)

Phase: 3

Status: Ongoing

Trial: enliGHten Trial

enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-weekly in Children with Growth Hormone Deficiency who have Completed a Prior TransCon hGH Clinical Trial

Status: Ongoing

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Trial: heiGHt Trial

heiGHt: A Multicenter, Phase 3, Randomized, Open-label, Active-controlled, Parallel-group Trial Investigating the Safety, Tolerability and Efficacy of TransCon hGH Administered Once a Week Versus Standard Daily hGH Replacement Therapy Over 52 Weeks in Prepubertal Children with Growth Hormone Deficiency (GHD)

Phase: 3

Status: Completed

Trial: fliGHt Trial

fliGHt: A Multicenter, Phase 3, Open-Label, 26-Week Trial Investigating the Safety, Tolerability and Efficacy of TransCon hGH Administered Once Weekly in Children with Growth Hormone Deficiency (GHD)

Phase: 3

Status: Completed

TURNER SYNDROME

Trial: New Insights Trial

Phase: 2

Official Title: New Insights: A Multicenter, Phase 2, Randomized, Open-label, Active-Controlled, Parallel Group Clinical Trial to Investigate the Safety, Tolerability, and Efficacy of Different Dose Levels of Once-Weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Individuals with Turner Syndrome

ClinicalTrials.gov Identifier: NCT05690386

Please visit clinicaltrials.gov for more information.

ONCOLOGY

Trial: transcendIT-101

transcendIT-101: A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors

Phase: 1 / 2

Status: Ongoing

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Trial: IL-βelieγe

IL-Belieγe: An open-label study of TransCon IL-2 β/γ as monotherapy or in combination therapy in adult participants with advanced or metastatic solid tumors.

Phase: 1 / 2

Status: Ongoing

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