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Also known as CRN04894 Oral Solution, Atumelnant
CRN04894 · 6 trials · 6 indications
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Atumelnant tablet, administered orally, once daily for 32 weeks. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo, administered orally, once daily for 32 weeks. |
| Treatment (Part A) | EXPERIMENTAL | Open-label, semi-sequential cohorts. |
| Active Treatment (Part B) | EXPERIMENTAL | Randomized, Parallel Arms, Double-Blind |
| Placebo (Part B) | PLACEBO_COMPARATOR | Randomized, Parallel Arms, Double-Blind |
| Open-Label Treatment (Part C) | EXPERIMENTAL | Open-label treatment period for participants entering Part C from Part A and B. |
| Sequential Dose | EXPERIMENTAL | Sequential, open-label, 12-week fixed-dose cohorts. |
| Multiple Ascending Doses | EXPERIMENTAL | Sequential, open-label, 10-day or 14-day fixed-dose cohorts. |
| Single Ascending Dose (Part 1) | EXPERIMENTAL | - |
| Multiple Ascending Dose (Part 2) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Atumelnant | DRUG | Atumelnant, tablets, once daily by mouth |
| Placebo | DRUG | Placebo, tablets, once daily by mouth |
| atumelnant (CRN04894) | DRUG | Atumelnant is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) receptor antagonist. |
| CRN04894 Oral Solution | DRUG | CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist. |
| Placebo Oral Solution | DRUG | Placebo |
Inclusion Criteria: 1. Male or female, between ≥18 to \<75 years of age at the time of signing the ICF. 2. Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment. 3. Have classic CAH due to 21-OHD confirmed by the Investiga...
CRN04894 is an oral small molecule drug developed by Crinetics Pharmaceuticals, Inc. (ticker CRNX). It is an investigational compound that has completed a Phase 1 clinical trial in healthy volunteers. The specific medical conditions it may treat have not been publicly disclosed.
CRN04894 targets adrenocorticotropic hormone (ACTH), a hormone involved in regulating cortisol production. By targeting ACTH, the drug is designed to modulate hormonal signaling. This mechanism is being explored in early-stage clinical development.
CRN04894 is being developed by Crinetics Pharmaceuticals, Inc., a biopharmaceutical company that trades on the Nasdaq under the ticker symbol CRNX. Crinetics is focused on discovering and developing therapeutics for endocrine-related conditions.
CRN04894 is in Phase 1 clinical development. It has completed one Phase 1 trial and is not yet approved by the FDA or any regulatory agency. The drug remains investigational and further studies are needed to evaluate its safety and efficacy.
CRN04894 has been studied in a single Phase 1 clinical trial, NCT06048887, titled "Single and Multiple-Ascending Dose Study of CRN04894 in Healthy Volunteers." This completed trial enrolled 88 healthy adult participants in the United States and used a randomized, double-blind, controlled design.
Yes, CRN04894 Oral Solution is an alternative name for CRN04894. Both refer to the same investigational small molecule developed by Crinetics Pharmaceuticals. The oral solution formulation was used in the Phase 1 trial NCT06048887.