A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects with Non-pharmacologically Treated Acromegaly

Primary Objective

The purpose of this study is to see if the Sponsor s investigational (research) medication called paltusotine is tolerable, safe, and effective in controlling the growth hormone (GH) levels of patients with acromegaly.

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Description

The purpose of this study is to see if the Sponsor’s investigational (research) medication called paltusotine is tolerable, safe, and effective in controlling the growth hormone (GH) levels of patients with acromegaly. GH acts on many parts of the body to promote growth in children. Once the growth in childhood is over, GH does not further increase height. In adults, it does not normally cause growth, but it helps to maintain normal body structure and function, including helping to keep blood sugar within set levels. However, the benign pituitary tumor that causes acromegaly makes too much GH and it affects the body by promoting abnormal growth of the bones of the hands, feet, face, jaw, and soft tissues. These high GH levels can lead to a wide range of cardiovascular (heart and blood vessels issues, e.g., high blood pressure), respiratory (lungs), endocrine (hormone) and metabolic (e.g., diabetes; elevated blood sugar) illnesses, as well as joint pain, weakness, and sometimes visual disturbances. Patients with acromegaly have too much IGF-1 in the blood caused by too much GH. Paltusotine is the study medication being tested. It is a somatostatin agonist which may help to lower the GH in the body. It is a tablet that will be taken by mouth (orally). Paltusotine is an “investigational” medication. This means the United States Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory authorities have not approved paltusotine for treating acromegaly or any other disease. Your regular doctor cannot prescribe paltusotine. Paltusotine is only available as part of this study.

Details
Age

Adult

Eligibility

Inclusion Criteria: - Must be at least 18 years of age - Confirmed diagnosis of acromegaly and either medically naive, not currently treated, or willing to washout during the study screening period. - Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control - Willing to provide signed informed consent Exclusion Criteria: - Pituitary radiation therapy within 3 years of Screening - Prior treatment with paltusotine - History of ineffective or intolerance to octreotide or lanreotide - History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years - Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer - Known history of HIV, hepatitis B, or active hepatitis C - History of alcohol or substance abuse in the past 12 months - Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study - Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities - Subjects with symptomatic cholelithiasis - Subjects with clinically significant abnormal findings during the Screening Period, or any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study - Subjects currently or previously using pegvisomant or cabergoline (within 16 weeks prior to Screening) or pasireotide LAR (within 24 weeks prior to Screening)

Type of Study

Treatment

Scope

National

Locations

Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Margaret Wierman,  MD

Margaret Wierman, MD

Study ID

Protocol Number: 22-1406

More information available at ClinicalTrials.gov: NCT05192382

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