Overview

This is a phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group, proof-of-concept study to assess vamifeport in adult participants with homeostatic iron regulator gene-related hereditary hemochromatosis (HFE-HH). The primary objective of the study is to assess the effect of vamifeport treatment on magnetic resonance imaging (MRI)-based liver iron concentration (LIC) in adult participants with HFE-HH.

Eligibility

Inclusion Criteria:

• Adult (≥ 18 years) and has provided written informed consent.
• Confirmed diagnosis of HFE-HH in medical history.
• Evidence of iron overload as shown by:
  • TSAT \> 45% (confirmed at 2 visits, at least 14 days apart) at Screening; and
  • Serum ferritin ≥ 200 nanogram per milliliter (ng/mL) and \< 5000 ng/mL (confirmed at 2 visits, at least 14 days apart) at Screening; and
  • MRI-based LIC between 3 and 16 mg/g (53.7 and 286.5 millimol per kilogram \[mmol/kg\]) dry weight (dw) at Screening.
• Body mass index between 18.5 and 32 kilograms per meter squared (kg/m\^2).

Exclusion Criteria:

• Clinically relevant laboratory abnormalities, 12-lead electrocardiogram (ECG) findings, or medical history.