A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROB… (NCT03792555) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)
United States, Brazil, Greece13 participantsStarted 2019-03-11
Plain-language summary
A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are responders to octreotide LAR or lanreotide depot.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male and female subjects 18 to 75 years of age
✓. Confirmed diagnosis of acromegaly that is controlled on stable doses of octreotide LAR or lanreotide depot
✓. 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
✕. Treatment naïve acromegaly subjects
✕. Prior treatment with paltusotine
✕. Pituitary surgery within 6 months prior to Screening or radiation therapy at any time prior to the study entry. Pituitary radiation therapy (within 3 to 4 years or more than 4 years prior to study entry) with recently documented elevated IGF-1 may be eligible.
✕. 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
✕. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
✕. History of alcohol or substance abuse in the past 12 months
✕
What they're measuring
1
Responder Criteria Was Based on the Mean of Two Consecutive Insulin-like Growth Factor-1 [IGF-1] Measurements ≤ULN at Week 13