Nevanimibe HCl for the Treatment of Classic CAH

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03669549
• Date of registration: 10/09/2018
• Prospective Registration: No
• Primary sponsor: Millendo Therapeutics US, Inc.
• Public title: Nevanimibe HCl for the Treatment of Classic CAH
• Scientific title: A Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of Classic Congenital Adrenal Hyperplasia
• Date of first enrolment: July 11, 2018
• Target sample size: 15
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03669549
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Brazil, Czechia, France, Israel, Spain

Key inclusion & exclusion criteria

Inclusion Criteria:

- Documented historical diagnosis of classic CAH due to 21-hydroxylase deficiency and/or
historical documentation of elevated 17-OHP

- Chronic glucocorticoid replacement therapy for at least 6 consecutive months prior to
screening

- Stable glucocorticoid and mineralocorticoid regimen for at least 4 weeks prior to
screening and throughout the treatment period of the study

Exclusion Criteria:

- Nonclassic CAH

- Other causes of adrenal insufficiency

- HIV, hepatitis B, or hepatitis C

- AST or ALT >2x ULN, bilirubin or serum creatinine >1.5x ULN



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Congenital Adrenal Hyperplasia

Intervention(s)

Drug: Nevanimibe hydrochloride

Primary Outcome(s)

Percentage of subjects achieving serum 17-OHP targets [Time Frame: Through Day 113]

Secondary ID(s)

ATR-101-202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors