Actively Recruiting
An Extension Study to Evaluate Safety and Efficacy in Participants Treated With CRN04894
Led by Crinetics Pharmaceuticals Inc. · Updated on 2025-09-23
150
Participants Needed
9
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of atumelnant (CRN04894).
CONDITIONS
Official Title
An Extension Study to Evaluate Safety and Efficacy in Participants Treated With CRN04894
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with congenital adrenal hyperplasia who completed a Crinetics CRN04894 study and were assessed to benefit from continued treatment
- Compliance with a stable glucocorticoid replacement regimen, taking hydrocortisone or equivalent daily dose at consent
- Female participants who engage in heterosexual intercourse must be of nonchildbearing potential, postmenopausal for at least 1 year with confirmation, or agree to use highly effective contraception
- Male participants must use condoms with partners of childbearing potential, be surgically sterile, or remain abstinent, and agree not to donate sperm during the study and 2 weeks after
You will not qualify if you...
- Any medical condition or lab findings judged unsafe or preventing study completion by the Investigator
- History or current alcohol or drug abuse within past 12 months
- Mental conditions impairing understanding or compliance
- Allergy or hypersensitivity to study materials or high adrenal insufficiency risk
- Pregnant or lactating women or women of childbearing potential unwilling to use contraception; males unwilling to use contraception
- Employees or immediate family of Crinetics employees
- Use of investigational drugs other than atumelnant within 60 days or 5 half-lives before consent
- History of cancer except cured skin or cervical carcinoma in situ
- Institutionalized by judicial or administrative order
- For those not currently on atumelnant: clinically significant abnormal labs or diseases including cardiovascular, moderate/severe renal insufficiency, significant liver disease, or elevated liver enzymes
- History of bilateral adrenalectomy, hypopituitarism, or need for chronic glucocorticoid therapy
- Major surgery within 4 weeks before screening
- Poorly controlled diabetes with HbA1c ≥8.5%
- Hypothyroidism without adequate hormone replacement
- Abnormal ECG findings exceeding specified thresholds or heart conduction blocks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Crinetics Study Site, Minneapolis, Minnesota 55454
Minneapolis, Minnesota, United States, 55455
Active, Not Recruiting
2
Crinetics Study Site
Morehead City, North Carolina, United States, 28557
Active, Not Recruiting
3
Crinetics Study Site
Córdoba, Córdoba Province, Argentina, 5000
Actively Recruiting
4
Crinetics Study Site
Botucatu, São Paulo, Brazil, 18618-686
Actively Recruiting
5
Crinetics Study Site
São Paulo, Brazil, 05403-000
Actively Recruiting
6
Crinetics Study Site
Munich, Bavaria, Germany, 80336
Actively Recruiting
7
Crinetics Study Site
Roma, Italy, 00161
Actively Recruiting
8
Crinetics Study Site
Birmingham, United Kingdom, CV22DX
Actively Recruiting
9
Crinetics Study Site
London, United Kingdom, NW1 2BU
Actively Recruiting
Research Team
C
Crinetics Clinical Trials Crinetics Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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