Health Condition 1: E35- Disorders of endocrine glands in diseases classified elsewhere
Conditions
Interventions
Intervention1: Paltusotine: Paltusotine, tablets, once daily by mouth for 24 weeks
Other Name: CRN00808
Control Intervention1: Placebo: Placebo, tablets, once daily by mouth
Sponsors
Crinetics Pharmaceuticals Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects >=18 years of age 2. Confirmed diagnosis of acromegaly and either medically naïve, not currently treated, or willing to washout during the study screening period. 3. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control 4. Willing to provide signed informed consent
Exclusion criteria
Exclusion criteria: Medical History and Medications 1. History of ineffectiveness or significant intolerance of octreotide or lanreotide treatment, as determined by the Investigator. 2. History of pituitary radiation therapy within 3 years of Screening. 3. Subjects with adrenal insufficiency, diabetes insipidus, or central hypogonadism who are not receiving adequate hormone replacement therapy at the time of Screening, as determined by the Investigator. 4. High risk pituitary tumor pattern as defined by: a. Compression of the optic chiasm or invasion of adjacent brain structures (other than sphenoid sinus or cavernous sinus) b. History of tumor growth within 1 year after surgery or radiation (unless it occurred during a period of medical therapy interruption) c. Anticipated requirement for neurosurgical intervention or radiation therapy within the time course of the study. d. Pituitary carcinoma currently or at any time in the past. 5. History of major surgery/surgical therapy for any cause within 4 weeks prior to Screening. 6. Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry, or with change in total daily insulin dose by >15% within 6 weeks prior to Screening. 7. History of unstable angina or acute myocardial infarction within the 12 weeks preceding the Screening Visit or other clinically significant cardiac disease at the time of screening as judged by the Investigator. 8. Known history of hepatitis B or human immunodeficiency virus, or active hepatitis C infection. 9. Active malignant disease within the last 5 years with exception of basal and squamous cell carcinoma of the skin with complete local excision and resected carcinoma in situ of cervix. 10. Concomitant mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study, and/or evidence of poor compliance with medical instructions. 11. Use of the following medications as outlined: a. Lanreotide (within 16 weeks before Screening) b. Pasireotide LAR (within 24 weeks prior to Screening), c. Pegvisomant (within 12 weeks before Screening), d. Dopamine agonists (within 12 weeks before Screening), e. Any combination of 2 or more acromegaly medications at Screening f. Proton pump inhibitors (from start of Screening) until the end of the study Note: Withdrawal of these medications should be part of the subjectâ??s medical care plan prior to Screening; entry into the study should not be the sole reason for withdrawal of a prior medication. 12. Current use of oral estrogen replacement therapy for 13. Current use of medications that are strong inducers of CYP3A4 within 2 weeks prior to Screening (refer to Section 6.7.2 Prohibited Medicine). 14. Known allergy or hypersensitivity to any of the test materials or related compounds. Screening Tests and Evaluations 15. Active COVID-19 confirmed or suspected based on clinical symptoms. 16. Symptomatic cholelithiasis. 17. Clinically significant concomitant disease including but not limited to cardiovascular disease, severe renal insufficiency (estimated glomerular filtration rate <30 mL/min/1.73 m2), or significant liver disease (in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who achieve biochemical response in IGF-1 (â?¤1.0Ã? the upper limit of normal [ULN]) at the End of the Randomized Control Phase (EOR)Timepoint: Time Frame: 24 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in IGF-1 to EORTimepoint: Time Frame: 24 Weeks;Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR. The total ASD score ranges from 0 and 70; lower scores indicate lower symptom burden. Timepoint: Time Frame: 24 Weeks;Proportion of subjects with GH 1 ng/mL at Week 22Timepoint: Time Frame: 24 Weeks;Proportion of subjects with IGF-1 1.3 ng/mL at EORTimepoint: Time Frame: 24 Weeks | — |
Countries
Argentina, Brazil, Bulgaria, China, France, Germany, Greece, Hungary, India, Italy, Peru, Poland, Russian Federation, Spain, United Kingdom, United States of America
Contacts
Public ContactThanuja Naidu
Pharm-Olam International (India) Pvt. Ltd
Outcome results
None listed