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Looking for participantsPhase2

An Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia

Sponsor: Crinetics Pharmaceuticals Inc.

NCT ID: NCT06712823

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
atumelnant (CRN04894) (drug)
How long the study runs
Study runs about 54 months (dates as stated)
About the drug or intervention
atumelnant (CRN04894) — drug: Atumelnant is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) receptor antagonist.
Patient visit burden
Not specified by the sponsor

In plain English

This extension study looks at the safety and how well atumelnant works in people with congenital adrenal hyperplasia (CAH), a condition the body makes too little of certain hormones. It is run by Crinetics Pharmaceuticals Inc. It is only open to people who have already finished the treatment period of an earlier Crinetics atumelnant CAH study.

Who can take part

  • People with CAH who finished the treatment period of an earlier Crinetics atumelnant study, and where the study doctor believes they benefited and would benefit from continuing the medicine
  • The study includes two groups: people who did not stop taking the study medicine between the end of the earlier study and the start of this one (Group 1), and people who did have a break in the medicine (Group 2)
  • Women who can become pregnant must use highly effective contraception, or be unable to have children (for example through surgery or after the menopause)
  • Men must use a condom with a female partner who can become pregnant, or be surgically sterile or long-term abstinent, and must not donate sperm during the study and for at least 2 weeks after the last dose
  • Willing and able to give consent and follow the study instructions and treatment

Who may not be able to

  • Any health problem or test result that, in the study doctor's view, could put the person's safety at risk or stop them finishing the study
  • Alcohol or drug misuse now or in the past 12 months
  • A mental health condition that means the person cannot understand the study, or a history of not following medical instructions
  • Known allergy or bad reaction to the study medicine or related substances, or being at high risk of adrenal insufficiency (the adrenal glands not making enough hormones), as judged by the study doctor
  • Women who are pregnant or breastfeeding, or people unwilling to use contraception as described
  • Employees of Crinetics or their close family
  • Taking another investigational (experimental) drug within 60 days or 5 half-lives (whichever is longer) before joining, or planning to join another study
  • Cancer within the last 5 years, apart from some fully treated skin or cervical cancers
  • Being held in an institution by court or official order
  • For people not currently taking atumelnant: significant abnormal test results or other serious conditions such as heart disease, severe kidney problems, or serious liver disease
  • For people not currently taking atumelnant: past removal of both adrenal glands, hypopituitarism (the pituitary gland not working properly), or any other condition needing long-term steroid treatment
  • For people not currently taking atumelnant: major surgery within 4 weeks before screening
  • For people not currently taking atumelnant: poorly controlled diabetes (HbA1c of 8.5% or higher)
  • For people not currently taking atumelnant: an underactive thyroid not properly treated
  • For people not currently taking atumelnant: certain abnormal heart rhythm test results at screening

What taking part involves

  • • Taking atumelnant, the same study medicine as in the earlier parent study
  • • Continuing treatment as part of an open-label extension (everyone receives the study medicine)

Time commitment: Not stated — ask the trial team about how long the study lasts, how many visits are needed, and what tests or checks are involved.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
16 Years to 74 Years
Who
All
Number of participants
200
Started
2025-02-25
Last checked
2025-06

Plain English Summary

What is this study?

  • • Testing a new treatment for congenital adrenal hyperplasia
  • • Phase2 - 200 participants
  • • The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of atumelnant (CRN04894)

Who can take part?

  • • Ages 16 Years to 74 Years
  • • Diagnosed with congenital adrenal hyperplasia

Where?

  • • Birmingham - Crinetics Study Site
  • • London - Crinetics Study Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of atumelnant (CRN04894).

More detail

This single-arm, long-term, open-label, study is designed to evaluate the safety, tolerability, and efficacy of atumelnant (CRN04894) in participants with congenital adrenal hyperplasia (CAH). Enrollment will be limited to individuals who completed a parent Crinetics atumelnant CAH study, and in the opinion of the Investigator had an acceptable benefit-risk assessment in the completed study and would benefit from continued dosing in this Open-Label Extension (OLE) study. A total of approximately 150 - 200 participants may be enrolled in the study.

Congenital Adrenal HyperplasiaClassic Congenital Adrenal Hyperplasia

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years - 74 Years
  • Who can join: All genders

Biomarkers mentioned

PR

Treatment history

Treatments you must have had:

  • ✓ with 2 follicle-stimulating hormone (FSH) measurements

What the study is looking for

  • ✓Participants are eligible to be included in the study only if all the following criteria apply:
  • ✓Group 1: Participants meeting the above criteria and did not have the study treatment administration interrupted between End...
  • ✓Group 2: Participants meeting the above criteria but had the study treatment administration interrupted between EOT of the...
  • ✓Female participants who engage in heterosexual intercourse must:
  • ✓Be of nonchildbearing potential, defined as either surgically sterile (ie, hysterectomy, bilateral salpingectomy for...

Who cannot take part

  • ✗Participants are excluded from the study if any of the following criteria apply:
  • ✗Any medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the...
  • ✗Participants have known history of (that is within the past 12 months), or current alcohol or drug abuse.
  • ✗Participants have any mental condition rendering him/her unable to understand the nature, scope, and possible...
  • ✗Participants have a known allergy or hypersensitivity to any of the test materials or related compounds, including...
See the full criteria
Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: 1. Participants with CAH who have completed the Treatment Period in a Crinetics parent atumelnant CAH study, and in the opinion of the Investigator had an acceptable benefit-risk assessment in the completed study and would benefit from continued dosing in this extension study. 1. Group 1: Participants meeting the above criteria and did not have study drug administration interrupted between End of Trial (EOT) of the parent study and the commencement of the OLE study. 2. Group 2: Participants meeting the above criteria but had study drug administration interrupted between EOT of the parent study and the commencement of the OLE study. 2. Female participants who engage in heterosexual intercourse must: 1. Be of nonchildbearing potential, defined as either surgically sterile (ie, hysterectomy, bilateral salpingectomy for at least 3 months, or bilateral oophorectomy), OR 2. Be postmenopausal with at least 1 year of amenorrhea. In participants with less than 1 year of amenorrhea, confirmation is required with 2 follicle-stimulating hormone (FSH) measurements. A documented, historical test result measured prior to Screening may be used as 1 of the 2 measurements. The FSH value should be ≥30 IU/L to confirm menopausal status, OR 3. Agree to use a highly effective method of contraception from the beginning of Screening until at least 2 weeks after the last dose of study drug. Contraceptive use by men and women also should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Periodic abstinence (ie, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. 3. Male participants agree to use a condom when sexually active with a female partner of childbearing potential from Screening until at least 2 weeks after the last dose of study drug (or be surgically sterile \[ie, vasectomy with a confirmed absence of sperm in ejaculate\]; or agree to remain abstinent on a long-term and persistent basis). Male participants should also agree to not donate sperm for the duration of the study and until at least 2 weeks after the last dose of study drug. 4. Participants are willing and able to give signed informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF). 5. Participants are willing and able to comply with the study procedures as specified in the protocol and comply with the study treatment. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 1. Any medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the participant's safety or ability to complete the study. 2. Participants have known history of (that is within the past 12 months), or current alcohol or drug abuse. 3. Participants have any mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study, and/or evidence of poor compliance with medical instructions. 4. Participants have a known allergy or hypersensitivity to any of the test materials or related compounds, including being at high risk of adrenal insufficiency as judged by the Investigator. 5. Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study. 6. Participant is an employee or immediate family member of an employee of Crinetics. 7. Participants who have been dosed with an investigational drug (other than atumelnant) in any prior clinical study within 60 days or 5 half-lives (whichever is longer) prior to informed consent or plan to use an investigational drug in another study. 8. Participants who have had an active malignant disease within the last 5 years prior to Screening excluding dermal squamous or basal cell carcinoma of the skin with complete local excision or resected cervical carcinoma in situ. 9. Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. Specific for Participants Not Currently Receiving Atumelnant 10. Participants with any clinically significant abnormal laboratory test during Screening or clinically significant concomitant disease other than CAH including but not limited to cardiovascular disease; moderate or severe renal insufficiency (estimated glomerular filtration rate \<30 mL/min/1.73 m2 using Chronic Kidney Epidemiology Collaboration \[CKD-EPI\] formula) at Screening; or Significant liver disease or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>3× upper limit of normal (ULN), and/or total bilirubin \>1.5×ULN during Screening. Participants with previously diagnosed Gilbert's syndrome not accompanied by other hepatobiliary disorders and associated with total bilirubin \<3.5 mg/dL (\<51.3 μmol/L) will be permitted. 11. Participants with a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy. 12. Participants with a history of major surgery/surgical therapy for any cause within 4 weeks prior to Screening. 13. Participants with poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5% (≥69 mmol/mL). 14. Participants with hypothyroidism who are not receiving adequate hormone replacement therapy based on thyroid hormone levels measured at the time of Screening, as determined by the Investigator. 15. Participant has an average (of 3 electrocardiograms \[ECGs\]) Fridericia's corrected QT (QTcF) interval \>450 milliseconds (msec) (men) or \>470 msec (women), time interval between P and R waves (PR interval) \>220 msec, time interval of the QRS complex (QRS) interval \>120 msec, second- or third-degree atrioventricular block, left bundle branch block, or hemiblock at Screening.

Where Is This Study? (2 UK sites)

Crinetics Study Site

Birmingham CV22DX, United Kingdom

Recruiting

Crinetics Study Site

London NW1 2BU, United Kingdom

Recruiting

How to Get in Touch

Crinetics Clinical Trials

Sponsor contact

CONTACT

833-827-9741 clinicaltrials@crinetics.com
Data sourced from ClinicalTrials.gov · Last verified: 2025-06