Atumelnant for Congenital Adrenal Hyperplasia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called atumelnant for individuals with classic congenital adrenal hyperplasia (CAH), a condition affecting hormone production. The trial aims to evaluate the effectiveness and safety of atumelnant compared to a placebo. Participants will take either atumelnant or a placebo pill once daily for 32 weeks. The trial seeks adults diagnosed with classic CAH due to 21-OHD who are on a stable hormone replacement regimen. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that atumelnant is likely to be safe for humans?
Research has shown that atumelnant is generally safe for use. Studies have found no serious side effects linked to this treatment. In earlier research, participants did not experience severe health issues, suggesting it is safe for most people. It's important to remember that these findings come from previous studies focused on the treatment's safety for humans.12345
Why do researchers think this study treatment might be promising for CAH?
Unlike the standard treatments for Congenital Adrenal Hyperplasia, which often involve glucocorticoids and mineralocorticoids, Atumelnant offers a fresh approach by targeting the condition differently. Atumelnant is thought to modulate the body's hormonal pathways in a more precise manner, potentially reducing the side effects commonly associated with current therapies. Researchers are particularly excited about Atumelnant because of its unique mechanism of action, which might improve hormone regulation more effectively and safely than existing options.
What evidence suggests that atumelnant might be an effective treatment for CAH?
Research has shown that atumelnant, which participants in this trial may receive, may help treat Congenital Adrenal Hyperplasia (CAH). Studies have found that atumelnant can lower certain hormones, such as androstenedione (A4), by up to 80%. This decrease occurs quickly and persists, which is important for controlling CAH symptoms. The treatment was generally well-tolerated, with no serious side effects reported. These findings suggest that atumelnant could be a good option for adults with classic CAH.13467
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either atumelnant or placebo once daily for 32 weeks, with an option for dose escalation at Week 20
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atumelnant
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Atumelnant tablet, administered orally, once daily for 32 weeks.
Matching placebo, administered orally, once daily for 32 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Crinetics Pharmaceuticals Inc.
Lead Sponsor
Citations
Topline Phase 2 results from Atumelnant in Congenital ...
Topline Phase 2 Results from Atumelnant in. Congenital Adrenal Hyperplasia (CAH). January 10, 2025. Page 2. 2. Safe Harbor Statement. This presentation ...
12537 Once Daily Oral Atumelnant (CRN04894) Induces ...
In conclusion, these data demonstrate rapid, profound, and sustained suppression of A4 and 17-OHP with 80 mg once daily, oral atumelnant. There were no serious ...
3.
crinetics.com
crinetics.com/crinetics-announces-positive-topline-results-from-phase-2-trial-of-atumelnant-in-congenital-adrenal-hyperplasia-cah/Crinetics Announces Positive Topline Results From Phase ...
This Phase 2 study demonstrated that atumelnant was well tolerated and resulted in a reduction of adrenal androgen levels so rapid and robust.
A Study to Evaluate Atumelnant in Adults With Congenital ...
The purpose of this study is to evaluate the efficacy, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD. Detailed Description. This is ...
OR07-06 Once-Daily Oral Atumelnant ... - PMC - NIH
We report results from 3 of 4 cohorts of a 12-week, Phase 2, open-label, dose-finding study of atumelnant in patients with CAH (NCT05907291).
Study Details | NCT05907291 | Evaluate the Safety, ...
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 ...
An Extension Study to Evaluate Safety and Efficacy in ...
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of atumelnant (CRN04894). Trial locations.
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