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A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome

ConditionsCushing SyndromeCushing DiseaseEctopic ACTH Syndrome
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCrinetics Pharmaceuticals Inc.

About this trial

A Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with CRN04894 (an adrenocorticotropic hormone \[ACTH\] receptor antagonist) in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome \[EAS\])

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult male or female, aged 18 years or more

Evidence of chronic 'active' ACTH-dependent Cushing's syndrome

Evidence of acutely 'active' ACTH-dependent Cushing's syndrome within 10 days of Day 1

Participants with documented ACTH-dependent Cushing's syndrome taking short-acting steroidogenesis inhibitors (ketoconazole, levoketoconazole, osilodrostat, or metyrapone) may participate after a washout period of at least 5 days, if they meet other study inclusion criteria, relative to Investigator's judgment. Participants with documented ACTH-dependent Cushing's syndrome taking cabergoline may participate after a washout period of at least 14 days, if they meet other study inclusion criteria

Disqualifiers

Women who are pregnant or lactating

History of bilateral adrenalectomy

Previous pituitary MRI findings of a putative ACTH-secreting lesion within 3 mm of the optic chiasm

Presence of any known malignancy

Trial design

Design model

Sequential

Treatments tested in this trial

  • atumelnant

    Drug

    Atumelnant is an orally active investigational agent which antagonizes the action of ACTH at its receptor administered as oral tablets.

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Multiple Ascending DosesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants with treatment emergent adverse events (TEAEs)

Time frame
Up to Day 15
2

Proportion of participants with adrenal insufficiency

Time frame
Up to Day 15
3

Proportion of participants with safety findings determined by laboratory testing

Time frame
Up to Day 15
4

Assessment of the maximum observed plasma concentration of CRN04894

Time frame
Up to Day 15

Secondary outcomes

1

Change from baseline in early morning serum cortisol

Time frame
Up to Day 15

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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