Acromegaly is typically caused by a growth hormone (GH) secreting tumor in the pituitary. Excess GH secretion results in excess secretion of insulin-like growth factor-1 (IGF-1) from the liver, which causes bone overgrowth, organ enlargement, and changes in glucose and lipid metabolism. The symptoms of acromegaly include abnormal growth of hands and feet and changes in shape of the bones that result in alteration of facial features. MedDRA version: 20.0 Level: PT Classification code 10000599 Te
Conditions
Interventions
Product Name: paltusotine
Product Code: CRN00808
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: paltusotine
Current Sponsor code: CRN00808
Other descriptive name: CRN00808
Concentration unit:
Sponsors
Crinetics Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Completed one of the parent studies (Acrobat Evolve (CRN00808-02) or Acrobat Edge (CRN00808-03)) 2. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control. 3. Willing to provide signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis) 2. Pituitary radiation since completing participation in parent studies. 3. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years 4. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab). 5. History of alcohol or substance abuse in the past 12 months 6. Use of any investigational drug (other than CRN00808) within the past 30 days or 5 half-lives, whichever is longer before Screening 7. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study. 8. Subjects with symptomatic cholelithiasis. 9. Subjects with clinically significant abnormal findings during the Screening Period, and 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is designed ito evaluate the long-term safety and tolerability of CRN00808 in acromegaly subjects; to evaluate the efficacy of CRN00808 in acromegaly patients.;Secondary Objective: Not Applicable;Primary end point(s): Primary endpoint: The primary endpoint is the incidence of treatment-emergent AEs (TEAEs) throughout the study. ;Timepoint(s) of evaluation of this end point: study duration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: -Change from W16 in IGF-1 levels; -Change from W16 in growth hormone (GH) levels Exploratory endpoints: -Proportion of subjects with the mean of their last 2 consecutive IGF-1 measurements =ULN at W52; -Proportion of subjects with the mean of their last 2 consecutive IGF-1 measurements =1.3×ULN at W52; -Proportion of subjects who achieve serum GH <5.0 ng/mL; -Proportion of subjects who achieve serum GH <2.5 ng/mL; -Number of consecutive visits with IGF-1 =ULN; -Number of consecutive visits with IGF-1 =1.3×ULN; -Change from baseline in serum Insulin-like growth factor binding protein-3 (IGFBP-3) levels; - Increase in serum GH, IGF-1, and IGFBP-3 levels after withdrawal of CRN00808; - Change from baseline in Acromegaly Quality of Life (AcroQoL) total score; - Change from baseline in acromegaly symptom diary (ASD total) score; - Subject treatment preference, as assessed by the Treatment Preference Questionnaire at W52; Other Safety Endpoints: - Clinical laboratory tests (hematology, serum chemistry, and urinalysis) at each post-baseline study visit; - Vital signs at each post-baseline study visit; - 12-lead ECG at each post-baseline study visit.;Timepoint(s) of evaluation of this end point: Specific time points are given in E.5.2 | — |
Countries
Brazil, Germany, Greece, Hungary, Serbia, Slovakia, United Kingdom, United States
Contacts
Public ContactCrinetics Cinical Trials
Crinetics Pharmaceuticals Inc
Outcome results
None listed