An exploratory Phase 2 study to evaluate the Safety and Efficacy of CRN00808 for the treatment of acromegaly

Phase 1

• Conditions: Acromegaly; MedDRA version: 20.0Level: PTClassification code 10000599Term: AcromegalySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2018-002230-20-IT
• Lead Sponsor: Crinetics Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-22
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1.Male and female subjects 18 to 70 years of age
2.Confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens
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
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 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

1.Treatment naïve acromegaly subjects
2.Prior treatment with CRN00808
3.Pituitary surgery within 6 months prior to Screening or radiation
therapy at any time prior to the study entry;
4.History or presence of malignancy except adequately treated basal cell
and squamous cell carcinomas of the skin within the past 5 years.
5.Use of any investigational drug within the past 30 days or 5 half-lives,
whichever is longer
6.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
7.History of alcohol or substance abuse in the past 12 months
8.Any condition that in the opinion of the investigator would jeopardize
the subject's appropriate participation in this study
9.Cardiovascular conditions or mediations associated with prolonged QT
or those which predispose subjects to heart rhythm abnormalities.
10.Subjects with symptomatic cholelithiasis
11.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
12.Subjects taking octreotide LAR at a dose higher than 40 mg, or lanreotide depot at a dose higher than 120 mg, or pasireotide LAR at a dose higher than 60 mg;
13.Subjects who usually take octreotide LAR or lanreotide depot less
frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks);

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified