A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms

A Double-Blind, Randomised, Placebo Controlled, Adaptive Design Study of the Efficacy, Safety and Pharmacokinetics of NT-814 in Female Subjects With Moderate to Severe Vasomotor Symptoms Associated With the Menopause

The purpose of this study is to determine the effectiveness of BAY3427080 (NT-814), taken once a day, in the treatment of troublesome post-menopausal symptoms.

This is a multi-centre, multi-country, double-blind, randomised, placebo-controlled Phase 2b study. The study will have a single-blind run-in period and will be adaptive with respect to the number of subjects recruited into each dose group. Four doses of BAY3427080 (40 mg once a day, 80 mg once a day, 120 mg once a day and 160 mg once a day) will be investigated and compared to placebo, in five parallel groups. Subjects will participate in the study for a total of approximately 19 weeks, comprising a screening period of 1 week, a 14 week treatment period, and then a final follow up visit 4 weeks after the end of the treatment period. There will be a total of 8 visits whilst participating in the study. Subjects will record their hot flashes in an electronic diary during the screening period to establish eligibility and throughout the study after randomisation.

Key Inclusion Criteria:

• Postmenopausal
• Body mass index between 18 and 38 kg/m2, inclusive
• Subject experiences moderate or severe hot flashes

Key Exclusion Criteria:

• Inability to comply with the use of prohibited and allowed medications as described in the protocol.
• Any prior or ongoing history of clinically relevant drug or alcohol abuse within 12 months of Screening.
• Any clinically significant prior or ongoing history of arrhythmias, either determined through clinical history or on ECG evaluation.
• Any clinically significant abnormal laboratory test result(s) measured at Screening.
• Any active ongoing condition that could have caused difficulty in interpreting vasomotor symptoms.
• Uncontrolled hypertension.
• A history or hyperthyroidism, hypothyroidism or abnormal thyroid function tests at Screening. Treated hypothyroidism with normal thyroid function test results at Screening is acceptable.