Phase 2Recruiting

A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea (KYRIAD)

A Phase 2, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea

Sponsor
Regeneron Pharmaceuticals (Industry)
Enrolment
34 planned
Conditions
Functional Hypothalamic Amenorrhea; FHA
Interventions
Mibavademab; Placebo
Ages
adults
Registry
NCT07235917

From the registry

This study is researching an experimental drug called mibavademab (also called "study drug"). The study is focused on participants with a condition called Functional Hypothalamic Amenorrhea (FHA). FHA is a condition where a woman stops menstruating because the brain is not sending the correct hormonal signals to the ovaries, which then are not able to cycle and ovulate properly. The aim of the study is to see how well the study drug helps the body make the hormones necessary for ovulation and reproduction, and to assess its safety. The study is looking at several other research questions, including: * Whether the drug helps bone health * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

Primary outcomes

  • Change from the highest serum estradiol observed during a 28-day period
Full record on ClinicalTrials.gov