A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-74
SponsorCrinetics Pharmaceuticals Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Male or female, between ≥18 to <75 years of age at the time of signing the ICF.
Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment.
Have classic CAH due to 21-OHD confirmed by the Investigator.
A4 >ULN and treated with <11 mg/m2/day (physiologic) GC doses
Disqualifiers
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.
Concomitant mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study, and/or evidence of poor compliance with medical instructions.
Trial design
Treatments tested in this trial
- Atumelnant
- Placebo
Treatment groups
150 Participants
are divided into 2 treatment groupsLocations
45Argentina
Crinetics Study Site1405, Buenos AiresBuenos Aires F.D., Argentina
Crinetics Study SiteC1012AAR, Buenos AiresBuenos Aires F.D., Argentina
Crinetics Study SiteC1199ABB, CABABuenos Aires F.D., Argentina
Crinetics Study SiteX5000JRD, CórdobaCórdoba Province, Argentina
Sponsors and collaborators
Crinetics Pharmaceuticals Inc.
Lead sponsor
Source ClinicalTrials.gov