A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

The PATHFINDER studies are recruiting patients to participate in clinical research for once-daily paltusotine for the treatment of acromegaly. If the studies are successful, paltusotine could be approved as the only ONCE-DAILY, ORAL therapy that gives patients looking for another treatment option an alternative to injections or twice-daily oral medications.

As a study participant, you could play an important role in advancing the options available for acromegaly treatment for yourself and many others living with this rare disease.

ABOUT THE STUDIES

The purpose of the PATHFNDR studies is to see if Crinetics Pharmaceuticals’ investigational medication, paltusotine, is safe and effective in patients with Acromegaly.

PATHFNDR-1 is a randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens. 

PATHFNDR-2 is a randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with non-pharmacologically treated acromegaly.

A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

Summary: Currently two global trials are recruiting patients diagnosed with acromegaly in the United States. These trials evaluate the efficacy, safety and tolerability of CAM2029, a new long-acting investigational formulation of octreotide. For more information on the trials, please follow the link to the Acromegaly&ME site.

Clinical trial HS-18-633: A Phase 3, Randomized, Double-blind, Placebo controlled, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly.

This trial (ClinicalTrials.gov Identifier: NCT04076462) is recruiting patients diagnosed with acromegaly who have been receiving regular treatment with octreotide or lanreotide. Patients that have been on a stable dose (of octreotide or lanreotide) for at least 3 months and have well-controlled levels of insulin-like growth factor 1 (IGF-1) may be eligible to participate.

Clinical trial HS-19-647: A Phase 3, Open-label, Single-arm, Multi-center Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly.

This trial (ClinicalTrials.gov Identifier: NCT04125836) is recruiting patients diagnosed with acromegaly who have been receiving regular treatment with octreotide or lanreotide for at least 3 months. Patients can also have previously received radiotherapy (irradiation) treatment. Levels of insulin-like growth factor 1 (IGF-1) do not need to be well-controlled. Patients who previously participated in and completed the HS-18-633 trial will be invited to continue participation for 6 months in the HS-19-647 trial.

Camurus AB is a Swedish biopharmaceutical company committed to developing long-acting medicines for the treatment of severe and chronic conditions.

Interested patients email: info@camurus.com.

Bone MicroArchitecture Clinical Trial Seeking Volunteers

Estimated Completion Date: March 2020

The following study, conducted by Dr. Pamela Freda of Columbia University, is now available for those located in the Northeastern USA and currently using Somavert. This would be a great way to get your foot into the door of working with a great doctor and to advance research.

Dr. Freda is conducting a study entitled Pilot Study of Bone Microarchitecture in Pegvisomant Treated Patients. This study is open to patients treated with Pegvisomant for at least 1 year with a normal IGF-1 level. It includes DXA, high resolution peripheral CT to examine bone micro architecture and measurement of bone markers and GH and IGF-1.

Requires a one-time 2-hour visit. The study is also registered on www.clinicaltrials.gov. 13 spots available at time of posting.

Interested patients call 212-305-4921 or 212-305-2254.