Health TrialsbyHealthPanel

A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia

ConditionsCongenital Adrenal HyperplasiaClassic 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Atumelnant

    Drug

    Atumelnant, tablets, once daily by mouth

  • Placebo

    Drug

    Placebo, tablets, once daily by mouth

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants with morning post-GC A4 ≤ ULN who are on physiologic GC replacement.

Time frame
Week 32

Secondary outcomes

1

Percent change from baseline of morning pre-GC A4

Time frame
Week 2
2

Percent change from baseline of morning pre-GC 17-OHP

Time frame
Week 32
3

Proportion of participants with morning pre-GC A4 ≤ ULN who are on physiologic GC replacement

Time frame
Week 32
4

Percent change from baseline in GC daily dose when morning post-GC A4 ≤ ULN

Time frame
Week 32

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Crinetics Pharmaceuticals Inc.

Lead sponsor

Source ClinicalTrials.gov
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