Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects with 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: EUCTR2020-005431-70-PL

Lead Sponsor: Crinetics Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 52

Inclusion Criteria

1.Male and female subjects =18 years of age
2.Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 =1.0×ULN) via stable monotherapy dose of protocol defined somatostatin receptor ligand therapy. (Upper limit of eligibility is mean
IGF-1 of 1.04 rounded to 2 decimal places.)
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 10

Exclusion Criteria

1.Treatment naïve acromegaly subjects
2.Prior treatment with paltusotine.
3. History of pituitary radiation therapy.
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.Known history of HIV, hepatitis B, or active hepatitis C.
7.History of alcohol or substance abuse in the past 12 months.
8.Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities.
9.Subjects with symptomatic cholelithiasis.
10.Subjects with clinically significant abnormal findings during the Screening Period, or 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
11.Subjects currently taking pasireotide LAR (within 24 weeks prior to Screening) or pegvisomant, dopamine agonists, or short acting somatostatin analogs (with 12 weeks prior to Screening)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of paltusotine versus placebo on IGF-1 response;Secondary Objective: To evaluate the effect of paltusotine versus placebo on IGF-1 level<br>To evaluate the effect of paltusotine versus placebo on GH response<br>To evaluate the effect of paltusotine versus placebo on acromegaly symptoms.;Primary end point(s): •Proportion of subjects who maintain biochemical response in IGF-1 (=1.0×the upper limit of normal [ULN]) at the End of the Randomized Control Phase (EOR);Timepoint(s) of evaluation of this end point: 36 weeks for the primary endpoint.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Change from baseline in IGF-1, in units of ULN, to EOR<br>•Proportion of subjects with GH <1.0 ng/mL at Week 34, out of those who had GH <1.0 ng/mL at Screening<br>•Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR.;Timepoint(s) of evaluation of this end point: 36 weeks for the secondary endpoint.