A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
Crinetics Pharmaceuticals Inc. · NCT07159841
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 1–17 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2, Phase 3
- Target enrollment
- 153
- US sites recruiting
- 10
- Study start
- January 22, 2026
- Record last updated
- October 16, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of atumelnant treatment in pediatric participants with classic congenital adrenal hyperplasia (CAH).
Being studied: Atumelnant; Placebo
Conditions: Congenital Adrenal Hyperplasia; Classic Congenital Adrenal Hyperplasia
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
Part A and B participants are eligible to be included in the study only if all of the following criteria apply:
- Male or female at birth, between 1 to \<18 years of chronological age at the time of signing the Informed Consent Form (ICF).
- Have a medically confirmed diagnosis of classic CAH due to 21-hydroxylase deficiency (21-OHD) based on standard medically accepted criteria such as elevated 17-OHP level, confirmed CYP21A2 genetic testing, positive newborn screening with confirmatory second tier testing, or cosyntropin stimulation.
- Participants must have an elevated morning serum A4 level >ULN during Screening obtained prior to morning glucocorticoid (GC) administration.
- Participants must be on a stable supraphysiologic GC replacement therapy for at least one month prior to Screening.
- Compliance, as judged per Investigator discretion, with GC replacement and mineralocorticoid replacement (if applicable) regimen documented during the Screening Period.
- Biochemical euthyroidism as determined by the Investigator.
Part C inclusion criteria require participants to complete treatment in either Part A or Part B and in the Investigator's opinion it would benefit the participant to continue in Part C, regardless of age.
Exclusion Criteria
Part A and Part B: Individuals in Part A and Part B who meet any of the following criteria will be excluded from participation in this study:
- Diagnosis of any form of CAH other than classic 21-OHD.
- Participants treated with other GCs within 30 days of Screening.
- Stress dose of GC therapy within 2 weeks of start of Screening, defined as any dose above the normal maintenance dose, including but not limited to intravenous (IV) or intramuscular (IM) hydrocortisone.
- Use of growth hormones within 1 week of start of Screening for short acting, or within 6 weeks of start of Screening for long acting.
- Use of a corticotropin-releasing factor receptor antagonist within 14 days of Screening.
- History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.
- Abnormal sleep/wake cycles (as determined by the Investigator).
- Female participants who are pregnant or lactating.
- Participants who have been dosed with an investigational drug (including atumelnant) in any prior clinical study within 60 days or 5 half-lives (whichever is longer) prior to the first dose.
- Individuals in Part C who do not meet the Part C Inclusion Criteria.
Recruiting US locations
UCSF Ron Conway Gateway Medical Building
San Francisco, CA 94158
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, IL 60611
Boston's Children's Hospital
Boston, MA 02115
University of Michigan
Ann Arbor, MI 48109
University of Minnesota
Minneapolis, MN 55454
Rutgers Robert Wood Johnson Medical School
New Brunswick, NJ 08901
Icahn School of Medicine at Mount Sinai-Mount Sinai Hospital
New York, NY 10029
Children's Hospital of Philadelphia
Philadelphia, PA 19104
Cook Children's Health Care System
Fort Worth, TX 76104
University of Virginia Health System
Charlottesville, VA 22903
Study contacts (from the official record)
- Crinetics Clinical Trials · 833-827-9741 · clinicaltrials@crinetics.com