Trial · Interventional

CompletedPhase 2Results postedRegistry data

Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital Adrenal Hyperplasia (TouCAHn)

NCTNCT05907291Other idCRN04894-03Other id2023-503488-40-00Other id2023

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names ACTH (corticotropin), does not test it. It appears in the description.

Overview

Status: Completed
Phase: Phase 2
Enrollment: 38 participants (actual)
Sponsor: Crinetics Pharmaceuticals Inc. · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 7 countries
United States, Argentina, Brazil, Germany, India, Italy, United Kingdom
Start: 3 Jul 2023
Primary completion: 22 Aug 2025
Completion: 22 Aug 2025
First posted: 18 Jun 2023
Last update posted: 10 Sept 2026
Conditions: Congenital Adrenal Hyperplasia · Classic Congenital Adrenal Hyperplasia

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2023202420252026

Ph 2
Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital Adrenal Hyperplasia (TouCAHn)
NCT05907291
3 Jul 2023 to 22 Aug 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this Phase 2, open-label, sequential dose cohort study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of atumelnant (CRN04894) in participants with classic congenital adrenal hyperplasia (CAH) caused by 21-hydroxylase deficiency.

Interventions

atumelnant (CRN04894)Drug

Arms1

Experimental
Sequential Dose
Sequential, open-label, 12-week fixed-dose cohorts.

Primary outcomes3

Outcomes the sponsor listed as primary.

Change From Baseline in Morning (Before 11:00) Serum Androstenedione (A4) PM Dosing
Time frame · Baseline and Week 12
Registry description
A4 is the principal biochemical measure of disease activity in adult CAH. Blood samples were collected for the measurement of serum concentration of A4 prior to glucocorticoid administration. Baseline is defined as the last non-missing morning window value prior to or on the same day as the first dose date of atumelnant. Change from baseline was obtained by subtracting post-baseline visit value minus baseline value.
Change From Baseline in Morning (Before 11:00) Serum Androstenedione (A4) AM Dosing
Time frame · Baseline and Week 12
Registry description
A4 is the principal biochemical measure of disease activity in adult CAH. Blood samples were collected for the measurement of serum concentration of A4 prior to glucocorticoid administration. Baseline is defined as the last non-missing morning window value prior to or on the same day as the first dose date of atumelnant. Change from baseline was obtained by subtracting post-baseline visit value minus baseline value.
Number of Participants Reporting of Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events Leading to Discontinuation Throughout the Study
Time frame · From Day 1 to Up to Week 16 (End of study)
Registry description
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. TEAEs were collected in the full analysis set which consisted of all participants who received at least one dose of study drug. A serious AE is defined by its severe clinical consequences: it is any event that results in death, is life-threatening, requires inpatient hospitalization, results in persistent disability, or requires medical intervention to prevent these outcomes.

Secondary outcomes(2)

Change From Baseline in Morning (Before 11:00) Serum 17-hydroxyprogesterone (17-OHP) PM Dosing
Time frame · Baseline and Week 12
Registry description
Elevated levels of the immediate enzyme substrate 17-OHP are indicative of CAH. The secondary efficacy endpoint was change from baseline in morning serum 17-OHP at Week 12. Baseline is defined as the last non-missing morning window value prior to or on the same day as the first dose date of atumelnant. Change from baseline was analyzed using the mean at baseline and at each visit, for all participants with both baseline and the corresponding visit values.
Change From Baseline in Morning (Before 11:00) Serum 17-hydroxyprogesterone (17-OHP) AM Dosing
Time frame · Baseline and Week 12
Registry description
Elevated levels of the immediate enzyme substrate 17-OHP are indicative of CAH. The secondary efficacy endpoint was change from baseline in morning serum 17-OHP at Week 12. Baseline is defined as the last non-missing morning window value prior to or on the same day as the first dose date of atumelnant. Change from baseline was analyzed using the mean at baseline and at each visit, for all participants with both baseline and the corresponding visit values.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline and Week 12

Change From Baseline in Morning (Before 11:00) Serum Androstenedione (A4) PM Dosing

Group	Value (nanograms per deciliter (ng/dL))	Spread
Atumelnant 40 mg QD PM	-601.2	143.07
Atumelnant 80 mg QD PM	-771.2	148.22
Atumelnant 120 mg QD PM	-953.4	191.02

Primary outcomeMean· Baseline and Week 12

Change From Baseline in Morning (Before 11:00) Serum Androstenedione (A4) AM Dosing

Group	Value (ng/dL)	Spread
Atumelnant 80 mg QD AM	-738.4	566.01

Primary outcomeCount of participants· From Day 1 to Up to Week 16 (End of study)

Number of Participants Reporting of Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events Leading to Discontinuation Throughout the Study

Group	Value (Participants)
Atumelnant 40 mg QD PM	8
Atumelnant 80 mg QD PM	8
Atumelnant 120 mg QD PM	5
Atumelnant 80 mg QD AM	10

Secondary and other outcome results(2)

Secondary outcomeLeast squares mean· Baseline and Week 12

Change From Baseline in Morning (Before 11:00) Serum 17-hydroxyprogesterone (17-OHP) PM Dosing

Group	Value (ng/dL)	Spread
Atumelnant 40 mg QD PM	-7714.5	2173.28
Atumelnant 80 mg QD PM	-8773.8	2288.82
Atumelnant 120 mg QD PM	-9611.0	2942.82

Secondary outcomeMean· Baseline and Week 12

Change From Baseline in Morning (Before 11:00) Serum 17-hydroxyprogesterone (17-OHP) AM Dosing

Group	Value (ng/dL)	Spread
Atumelnant 80 mg QD AM	-7893.8	5414.95

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Atumelnant 40 mg QD PMParticipants received a daily (QD) oral dose of 40mg atumelnant between 22:00-24:00 hours.	0 / 11	0 / 11	8 / 11
Atumelnant 80 mg QD PMParticipants received a daily (QD) oral dose of 80 mg atumelnant between 22:00-24:00 hours.	0 / 11	0 / 11	8 / 11
Atumelnant 120 mg QD PMParticipants received a daily (QD) oral dose of 120 mg atumelnant between 22:00-24:00 hours.	0 / 6	0 / 6	5 / 6
Atumelnant 80 mg QD AMParticipants received a daily (QD) oral dose of 80 mg atumelnant between 06:00 - 10:00 hours with glucocorticoid reduction.	0 / 10	0 / 10	10 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 16 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Male or female participants ≥18 to 75 years of age at the time of signing the Informed Consent Form (ICF). Participants ≥16 years of age may be included in sites located in the United States 2. Classic 21-hydroxylase deficiency 3. On a stable regimen of glucocorticoid replacement (eg, hydrocortisone, prednisolone, prednisone, methylprednisolone) 4. Compliance with glucocorticoid replacement and mineralocorticoid replacement (if applicable) regimen during the Screening Period 5. Minimum total daily dose of ≥15 mg hydrocortisone (or equivalent). For Cohort 4, a mean daily dose of ≥11 mg/m²/day of hydrocortisone or hydrocortisone equivalents will be used for inclusion 6. If on estrogen therapy (any route), dose must be stable for at least 3 months prior to Screening Exclusion Criteria: 1. Diagnosis of any other form of CAH other than classic 21-hydroxylase deficiency 2. Dexamethasone use within 30 days of Screening for Cohorts 1-3. In Cohort 4, dexamethasone is permitted 3. History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy 4. Night shift workers or any other reason for abnormal sleep/wake cycles 5. Clinically significant unstable medical condition or chronic disease other than CAH 6. History of major surgery/surgical therapy for any cause within 4 weeks prior to Screening 7. Diabetes mellitus treated with insulin for less than 6 weeks prior to Screening, or with change in total daily insulin dose by \>15% within 6 weeks prior to Screening 8. Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%(≥69 mmol/mL), or estimated HbA1c based on fructosamine if HbA1c is not evaluable (eg, due to hemoglobinopathies) 9. Participants with hypothyroidism who are not receiving adequate hormone replacement therapy based on thyroid hormone levels measured at the time of Screening 10. History of unstable angina or acute myocardial infarction within 12 weeks prior to Screening or other clinically significant cardiac disease at the time of Screening 11. History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ 12. Pregnant or lactating 13. Known history of illicit drug or alcohol abuse within the last year 14. Use of antiandrogen therapy in the past 3 months (eg, spironolactone, finasteride, cyproterone acetate, flutamide) 15. Use of testosterone, androgen-containing supplements, aromatase inhibitors, or growth hormone

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