Phase 3: testing Atumelnant for Congenital Adrenal Hyperplasia
This study wants to measure the how well it works, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.
Official registry: https://clinicaltrials.gov/study/NCT07144163 · Crinetics Pharmaceuticals Inc. · enrollment listed as 150
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Atumelnant, or Placebo. The registry lists allocation as randomized. This study wants to measure the how well it works, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.
They plan to enroll about 150 people at 75 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants With Classic Congenital Adrenal Hyperplasia (Calm-CAH)
Interventions: Atumelnant, Placebo
Primary outcome (registry wording): Proportion of participants with morning post-GC A4 ≤ ULN who are on physiologic GC replacement.
Who it is for (from inclusion criteria)
- Ages 18 Years to 74 Years
- Male or female, between ≥18 to \<75 years of age at the time of signing the ICF
- Have classic CAH due to 21-OHD confirmed by the Investigator
- Participants with Visit 2 levels of morning serum A4 as follows:
- A4 \>ULN and treated with \<11 mg/m2/day (physiologic) GC doses
- OR normal A4 (\>0.5xULN to ≤1xULN) and treated with ≥14 mg/m2/day GC doses
- OR A4 \>ULN and treated with ≥11 mg/m2/day GC doses
- If treated with mineralocorticoids (fludrocortisone), the dose should be stable for at least 1 month prior to Screening without orthostatic hypotension, and with serum sodium and potassium in the normal range
Who the registry excludes
- Diagnosis of any form of CAH other than classic 21-OHD
- History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic GC therapy
- Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH
- History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ
- Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study
- Known history of, or concern for, risk of hypersensitivity reaction to atumelnant or any of its excipients
- Participants with an increased risk of developing adrenal insufficiency as judged by the Investigator
Public study contact (from the registry)
Crinetics Clinical Trials
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
75 listed- Crinetics Study Site — Los Angeles, California (recruiting)
- Crinetics Study Site — Aurora, Colorado (recruiting)
- Crinetics Study Site — Gainesville, Florida (recruiting)
- Crinetics Study Site — Atlanta, Georgia (recruiting)
- Crinetics Study Site — Chicago, Illinois (recruiting)
- Crinetics Study Site — Baltimore, Maryland (recruiting)
- Crinetics Study Site — Ann Arbor, Michigan (recruiting)
- Crinetics Study Site — Minneapolis, Minnesota (recruiting)
- Crinetics Study Site — Rochester, Minnesota (recruiting)
- Crinetics Study Site — New Brunswick, New Jersey (recruiting)
- Crinetics Study Site — Philadelphia, Pennsylvania (recruiting)
- Crinetics Study Site — Pittsburgh, Pennsylvania (recruiting)
+ 60 sites outside the US on the same record
FAQ about this NCT record
Is NCT07144163 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07144163?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07144163?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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