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-DE
• Lead Sponsor: Crinetics Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-17
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

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

Inclusion Criteria

1.Male and female subjects 18 to 75 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 subjects in
Group 3, 4, or 5 who have undergone pituitary radiation therapy at any
time prior to the study entry. A history of radiation therapy is not a
restriction for subjects in Group 1 or 2. If a subject in Group 3, 4, or 5
has undergone pituitary radiation therapy =4 years prior to Screening
and has had a documented IGF-1 =1.3×ULN within 2 years prior to Screening OR if a subject has undergone pituitary radiation therapy between 3 and 4 years prior to Screening and has had a documented IGF-1 =1.3×ULN within 1 year
prior to Screening, the subject may be included in the study;
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.Subjects with hepatitis B, Human Immunodeficiency Virus (HIV), or
hepatitis C infection. Subjects with previous hepatitis C infection that is
now cured may be eligible.
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