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

Status: Recruiting

The purpose of this research study is to evaluate the safety and effectiveness of a new investigational drug called atumelnant for adults with classic Congenital Adrenal Hyperplasia (CAH) caused by 21-hydroxylase deficiency (21-OHD). Researchers want to learn how well atumelnant helps control CAH symptoms, how the body processes the drug (pharmacokinetics or PK), and whether it produces the expected effects in the body (pharmacodynamics or PD). The study will also evaluate whether participants may be able to reduce their steroid (glucocorticoid) dose while taking atumelnant.

I'm interested

Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of classical congenital adrenal hyperplasia (CAH)
• on a stable dose of your current steroid (glucocorticoid) treatment
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• diagnosis of any other form of CAH
• are pregnant, breastfeeding, or unable/unwilling to use effective birth control during the study
• see link to clinicaltrials.gov for complete exclusion criteria
Interventions:

Drug: Atumelnant, Drug: Placebo

Conditions:

Diabetes & Endocrine, Rare Diseases

Keywords:

CAH, Classic Congenital Adrenal Hyperplasia

Study Contact: Kyriakie Sarafoglou - saraf010@umn.edu
Principal Investigator: Kyriakie Sarafoglou
Phase: PHASE3
IRB Number: STUDY00027082
See this study on ClinicalTrials.gov

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