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Active (not recruiting) Phase 3 2024-519579-24-00

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants with Classic Congenital Adrenal Hyperplasia

Phase 3 – large-scale trial before approval
Conditions: Classic Congenital Adrenal Hyperplasia

Sponsor: Crinetics Pharmaceuticals Inc.

trial.available_in: БГ
Overview
Trial status: Authorised Percent change from baseline of morning A4 at Week 2 Percent change from baseline of morning 17-OHP at Week 32  Proportion of participants with morning pre-GC A4 ≤ULN who are on physiologic GC replacement at Week 32  Percent change from baseline in GC daily dose when morning post-GC A4 ≤ULN at week 32 Proportion of participants with morning post-GC A4 ≤ULN who are on physiologic GC replacement at Week 32
Description
Percent change from baseline of morning A4 at Week 2 Percent change from baseline of morning 17-OHP at Week 32  Proportion of participants with morning pre-GC A4 ≤ULN who are on physiologic GC replacement at Week 32  Percent change from baseline in GC daily dose when morning post-GC A4 ≤ULN at week 32
Who can participate
Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 54 participants
Interventions
Atumelnant 120 mg tablets
Drug
Atumelnant 80 mg tablets
Drug
Tablet
Drug
Locations 7
Austria (1)
France (1)
Germany (1)
Italy (1)
Netherlands (1)
Poland (1)
Sweden (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
02.12.2025
Registry ID
2024-519579-24-00
Source
euclinicaltrials.eu
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