cimdelirsen (IONIS-GHR-LRx) / Ionis - LARVOL DELTA

A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly (clinicaltrials.gov) - P2 | N=34 | Completed | Sponsor: Ionis Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Oct 2023 ➔ May 2023 | Trial primary completion date: Aug 2023 ➔ Jul 2022

Monotherapy • Trial completion • Trial completion date • Trial primary completion date • Acromegaly • Endocrine Disorders • IGF1

Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - P2 | N=39 | Completed | Sponsor: Ionis Pharmaceuticals, Inc. | Trial primary completion date: Jul 2022 ➔ Mar 2022

Trial primary completion date • Acromegaly • Endocrine Disorders • IGF1

Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - P2 | N=39 | Completed | Sponsor: Ionis Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jul 2023 ➔ Jul 2022 | Trial primary completion date: Jul 2023 ➔ Jul 2022

Trial completion • Trial completion date • Trial primary completion date • Acromegaly • Endocrine Disorders • IGF1

Placebo-Controlled and Open-Label Extension Study of a Novel Hepatic-Targeted Antisense Cimdelirsen (IONIS-GHR-LRx) Under Investigation in Acromegaly Patients) (ENDO 2022) - P2 | "Once monthly SC cimdelirsen injections demonstrated long-term safety, were well-tolerated, and resulted in significant reductions in GHBP and IGF-1 AUC without increased GH levels. Cimdelirsen also improved PRO, collectively supporting further development of this novel, liver-directed potential therapy for uncontrolled acromegaly."

Clinical • Acromegaly • Endocrine Cancer • Endocrine Disorders • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Oncology • Pain • Pituitary Gland Carcinoma • Thrombocytopenia • GHR • IGF1 • SSTR

A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly (clinicaltrials.gov) - P2; N=40; Active, not recruiting; Sponsor: Ionis Pharmaceuticals, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Monotherapy • Acromegaly • Endocrine Disorders • IGF1

Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - P2; N=39; Active, not recruiting; Sponsor: Ionis Pharmaceuticals, Inc.; Enrolling by invitation ➔ Active, not recruiting

Clinical • Enrollment closed • Acromegaly • Endocrine Disorders • IGF1

Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - P2; N=39; Enrolling by invitation; Sponsor: Ionis Pharmaceuticals, Inc.; N=60 ➔ 39

Clinical • Enrollment change • Acromegaly • Endocrine Disorders • IGF1

Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - P2; N=43; Completed; Sponsor: Ionis Pharmaceuticals, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Acromegaly • Endocrine Disorders • IGF1

Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - P2; N=60; Enrolling by invitation; Sponsor: Ionis Pharmaceuticals, Inc.; Recruiting ➔ Enrolling by invitation

Clinical • Enrollment status • Acromegaly • Endocrine Disorders • IGF1

A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Ionis Pharmaceuticals, Inc.; Trial completion date: Apr 2023 ➔ Aug 2023; Trial primary completion date: Apr 2023 ➔ Aug 2023

Clinical • Monotherapy • Trial completion date • Trial primary completion date • Acromegaly • Endocrine Disorders • IGF1

Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - P2; N=43; Active, not recruiting; Sponsor: Ionis Pharmaceuticals, Inc.; Trial completion date: Dec 2020 ➔ Apr 2021

Clinical • Trial completion date • Acromegaly • Endocrine Disorders • IGF1

Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Ionis Pharmaceuticals, Inc.; Trial completion date: Jan 2021 ➔ Jun 2023; Trial primary completion date: Jan 2021 ➔ Jun 2023

Clinical • Trial completion date • Trial primary completion date • Acromegaly • Endocrine Disorders • IGF1

Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - P2; N=43; Active, not recruiting; Sponsor: Ionis Pharmaceuticals, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Acromegaly • Endocrine Disorders • IGF1

Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Ionis Pharmaceuticals, Inc.; Trial completion date: Jul 2020 ➔ Dec 2020; Trial primary completion date: Jul 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • Acromegaly • Endocrine Disorders • IGF1

An open label study to assess the safety, tolerability, and efficacy of the study drug, ISIS 766720, administered monthly in patients with acromegaly (a hormonal disorder that results from too much growth hormone in the body) Nyílt vizsgálat, a havonta alkalmazott ISIS 766720 vizsgálati készítmény biztonságosságának, tolerálhatóságán (clinicaltrialsregister.eu) - P2; N=40; Ongoing; Sponsor: Ionis Pharmaceuticals, Inc.

Clinical • Monotherapy • New P2 trial • Acromegaly • Endocrine Disorders • Musculoskeletal Diseases • Oncology • IGF1

A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Ionis Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting; Initiation date: Sep 2020 ➔ Dec 2020

Clinical • Enrollment open • Monotherapy • Trial initiation date • Acromegaly • Endocrine Disorders • IGF1

A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly (clinicaltrials.gov) - P2; N=40; Not yet recruiting; Sponsor: Ionis Pharmaceuticals, Inc.

Clinical • Monotherapy • New P2 trial • Acromegaly • Endocrine Disorders • IGF1

Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in up to 42 Adult Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Ionis Pharmaceuticals, Inc.; Trial completion date: Dec 2019 ➔ Jul 2020; Trial primary completion date: Sep 2019 ➔ Jul 2020

Clinical • Trial completion date • Trial primary completion date

Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Ionis Pharmaceuticals, Inc.; N=42 ➔ 60

Clinical • Enrollment change

Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - P2; N=42; Recruiting; Sponsor: Ionis Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in up to 42 Adult Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Ionis Pharmaceuticals, Inc.; N=42 ➔ 60

Clinical • Enrollment change

An open label study to assess the long term safety of the study drug, ISIS 766720, in patients with acromegaly (a hormonal disorder that results from too much growth hormone in the body) Nyílt vizsgálat, az ISIS 766720 vizsgálati készítmény hosszú távú biztonságosságának értékelésére akromegáliában szenvedő b (clinicaltrialsregister.eu) - P2; N=42; Ongoing; Sponsor: Ionis Pharmaceuticals, Inc.

Clinical • New P2 trial

Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - P2; N=42; Not yet recruiting; Sponsor: Ionis Pharmaceuticals, Inc.

Clinical • New P2 trial