ClinicalTrials.gg
RecruitingNCT06712823CALM2-CAHUpdated Jun 29, 2026

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

A Phase 2 interventional study of atumelnant (CRN04894) in Congenital Adrenal Hyperplasia and Classic Congenital Adrenal Hyperplasia, sponsored by Crinetics Pharmaceuticals Inc.. Recruiting at 13 sites in 6 countries. Open to participants aged 16 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Crinetics Pharmaceuticals Inc. (part of Vertex Pharmaceuticals Incorporated) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
16 Years to 74 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Congenital Adrenal Hyperplasia
  • Classic Congenital Adrenal Hyperplasia

Keywords

  • Congenital Adrenal Hyperplasia
  • CAH
  • CRN04894
  • atumelnant
03

In context

Adrenal Hyperplasia, Congenital

101 studies on the registry are indexed under Adrenal Hyperplasia, Congenital; 28 are open to participants now.

This study's planned enrollment of 200 is above the median of 37 across 50 interventional studies indexed under Adrenal Hyperplasia, Congenital.

Browse Adrenal Hyperplasia, Congenital studies →

Lead sponsor

Crinetics Pharmaceuticals Inc. is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 6 (50%) have results posted.

First submitted before Crinetics Pharmaceuticals Inc. became part of Vertex Pharmaceuticals Incorporated.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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 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 , 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

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 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 , who are unwilling to use highly effective 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 drug (other than atumelnant) in any prior clinical study within 60 days or 5 half-lives (whichever is longer) prior to 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 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 \<30 mL/min/1.73 m2 using Chronic Kidney Epidemiology Collaboration [CKD-EPI] formula) at Screening; or Significant liver disease or (ALT) and/or aspartate aminotransferase (AST) >3× (ULN), and/or total >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 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 (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 [ECGs]) Fridericia's (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.
Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Treatment

    Open-label treatment period (up to 2 years). The maximum atumelnant dose permitted is not to exceed the highest atumelnant dose explored in a parent study for the indication.

    Drug: atumelnant (CRN04894)

Interventions

  • Atumelnant is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) receptor antagonist.

06

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs), including treatment-emergent serious adverse events (SAEs), adverse events of special interest (AESI [adrenal insufficiency]) and any adverse events (AEs) leading to discontinuation

    Time frame: Week 108

  2. Incidence of glucocorticoid (GC) deficiency / adrenal insufficiency and adrenal crisis

    Time frame: Week 108

  3. Incidence of hospitalizations related to congenital adrenal hyperplasia (CAH)

    Time frame: Week 108

  4. Change from baseline in morning (before 11:00 AM) serum androstenedione (A4) over time

    Time frame: Week 108

Secondary outcomes

  1. Change from baseline in morning (before 11:00 AM) serum 17-hydroxyprogesterone (17-OHP) over time

    Time frame: Week 108

  2. Change from baseline in daily glucocorticoid (GC) dose (hydrocortisone [HC] mg equivalents body surface area [BSA] adjusted) over time

    Time frame: Week 108

07

Study locations

10 of 13 sites recruiting
  • Crinetics Study Site, Minneapolis, Minnesota 55454
    Minneapolis, Minnesota 55455, United States
    Active, not recruiting

    Not enrolling at this site.

  • Crinetics Study Site
    Morehead City, North Carolina 28557, United States
    Active, not recruiting

    Not enrolling at this site.

  • Crinetics Study Site
    Philadelphia, Pennsylvania 19104, United States
    Active, not recruiting

    Not enrolling at this site.

  • Crinetics Study Site
    Córdoba, Córdoba Province 5000, Argentina
    Recruiting
  • Crinetics Study Site
    Curitiba, Paraná 80030-110, Brazil
    Recruiting
  • Crinetics Study Site
    Porto Alegre, Rio Grande do Sul 90410-000, Brazil
    Recruiting
  • Crinetics Study Site
    Botucatu, São Paulo 18618-686, Brazil
    Recruiting
  • Crinetics Study Site
    Rio de Janeiro, 20231-092, Brazil
    Recruiting
  • Crinetics Study Site
    São Paulo, 05403-000, Brazil
    Recruiting
  • Crinetics Study Site
    Munich, Bavaria 80336, Germany
    Recruiting
  • Crinetics Study Site
    Roma, 00161, Italy
    Recruiting
  • Crinetics Study Site
    Birmingham, CV22DX, United Kingdom
    Recruiting
  • Crinetics Study Site
    London, NW1 2BU, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06712823
Responsible party
Sponsor
First posted
Dec 2, 2024
Start date
Feb 25, 2025
Primary completion
Jul 2029 (estimated)
Completion
Aug 2029 (estimated)
Last update
Jun 29, 2026

Study contacts

Crinetics Clinical Trials
Contact
clinicaltrials@crinetics.com
833-827-9741

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Atumelnant

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