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Study on the Safety and Effectiveness of CRN04894 for Patients with Congenital Adrenal Hyperplasia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called , a genetic disorder affecting the adrenal glands, which are responsible for producing important hormones. The trial will evaluate a new treatment called , which is an . This means it works by blocking a specific receptor involved in hormone production. The study aims to assess the safety and effectiveness of in managing this condition.

Participants in the study will receive over a period of 12 weeks. The treatment will be given in a sequential dose manner, meaning the dose may be adjusted as the study progresses. The study will also involve monitoring the levels of certain hormones in the blood, such as androstenedione, to see how they change with the treatment. This will help determine how well the treatment is working.

In addition to , other medications may be used in the study, including , , , , and . These medications are commonly used to manage symptoms and hormone levels in people with . Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment. The study will help gather important information about the potential benefits and any side effects of for people with this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current treatment regimen.

    Participants must have a stable glucocorticoid replacement regimen and meet other health requirements.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health metrics, including serum androstenedione (A4) levels.

    This assessment helps in evaluating the effectiveness of the treatment over the course of the study.

  3. Step 3

    Treatment phase

    Participants receive CRN04894 treatment orally for a duration of 12 weeks.

    The treatment aims to evaluate safety, tolerability, and efficacy in managing congenital adrenal hyperplasia.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to track any treatment-emergent adverse events (TEAEs) and changes in health status.

    Participants' serum A4 levels are measured before 11:00 AM at Week 12 to assess the primary efficacy endpoint.

  5. Step 5

    Final evaluation

    At the end of the 12-week period, a final evaluation is performed to determine the overall impact of the treatment.

    The study concludes with an analysis of the collected data to assess the primary and secondary endpoints.

Who can join the trial?

6 criteria

  • Participants must be **male or female** and between **18 to 75 years old**. In the United States, participants can be as young as **16 years old**.
  • Participants must have a condition called **classic 21-hydroxylase deficiency**, which needs to be confirmed by a doctor and approved by a medical expert.
  • Participants should be on a **stable treatment plan** for replacing certain hormones called **glucocorticoids**. This means no changes in the dose of more than **5 mg per day** of a medicine like **hydrocortisone** in the last **6 months** before the study starts.
  • Participants must follow their hormone replacement treatment plan as judged by the doctor during the **Screening Period**.
  • Participants need to take at least **15 mg of hydrocortisone** (or an equivalent medicine) every day.
  • If participants are on **estrogen therapy** (a hormone treatment), the dose must not have changed for at least **3 months** before the study starts.

Who cannot join the trial?

4 criteria

  • Individuals who are not diagnosed with Congenital Adrenal Hyperplasia. This is a condition present from birth that affects the adrenal glands, which are small glands located on top of each kidney.
  • Individuals who are not within the specified age range for the study.
  • Individuals who are not part of the specified clinical trial groups.
  • Individuals who are not considered part of the vulnerable population selected for the study.
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Investigated drugs

CRN04894 is a medication being studied for its safety and effectiveness in treating individuals with Congenital Adrenal Hyperplasia. This trial aims to understand how well the medication works by observing changes in specific hormone levels in the blood. The study also focuses on ensuring that the medication is safe and well-tolerated by participants.

What is already known about the treatment

CRN04894 – This medication is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating congenital adrenal hyperplasia. It is in the experimental phase and not yet widely recognized in medical literature. The main therapeutic indication is to manage congenital adrenal hyperplasia, a condition affecting hormone production. CRN04894 works by targeting specific receptors involved in hormone regulation, aiming to reduce abnormal hormone levels. It is classified as a hormone receptor modulator.

Investigated diseases

Congenital Adrenal Hyperplasia – This is a group of genetic disorders affecting the adrenal glands, which are responsible for producing certain hormones. In this condition, the adrenal glands produce an insufficient amount of cortisol and sometimes aldosterone, while producing an excess of androgen. This hormonal imbalance can lead to symptoms such as ambiguous genitalia in newborns, early onset of puberty, and rapid growth during childhood. Over time, individuals may experience issues with fertility, irregular menstrual cycles, and other hormone-related problems. The severity of symptoms can vary widely, depending on the specific genetic mutation and the level of enzyme deficiency.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503488-40-00Protocol codeCRN04894-03Estimated enrolment33 patientsSponsorCrinetics Pharmaceuticals Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).