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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

A rare condition called Congenital Adrenal Hyperplasia affects the adrenal glands, which are small organs that make hormones needed for growth, metabolism, and stress response. When this condition is present, the body produces too much of certain hormones and not enough of others, leading to symptoms such as early puberty, salt loss, or low blood sugar. The study evaluates an oral tablet known by the code name CRN04894 as a possible new treatment to help balance these hormone levels.

The purpose of the study is to determine whether the medication is safe to use and whether it can effectively lower excess hormone levels. Safety will be measured by tracking any side effects that occur during the trial, while effectiveness will be judged by the change in the blood level of a hormone called androstenedione, which is often high in this condition. A secondary measurement will look at changes in 17-OHP, another hormone used to monitor disease control.

Participants will take the study tablet once daily for a period of 12 weeks. Throughout the study they will attend several clinic visits where blood samples are taken before 11 a.m. to check hormone levels and any possible side effects. Researchers will review the information from these visits to assess safety and how well the medication works.

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 9 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503488-40-00Protocol codeCRN04894-03Estimated enrolment33 patientsSponsorCrinetics Pharmaceuticals Inc.

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