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

Study acronym: KYRIAD
StatusRecruiting
PhasePhase 2
Started2026-03-11
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Aug 20, 2027 → Jan 28, 2028
See other at-risk trials from Regeneron

Amendment history

2026-10-02
notable
Primary completion pushed: 2027-08-20 → 2028-01-28
Completion pushed: 2027-12-08 → 2028-05-17
2026-07-13
minor
Study Status, Contacts/Locations v8
Study sites8→10
2026-06-16
minor
Study Status, Contacts/Locations v7
Study sites6→8
2026-05-19
minor
Study Status, Contacts/Locations v6
Study sites5→6
2026-04-23
minor
Study Status, References v5
Show 4 earlier versions
2026-03-25
minor
Study Status v4
Primary completion date2027-08-23→2027-08-20
Start dateestimated 2026-03-31→confirmed 2026-03-11
2026-03-11
minor
Study Status v3
Start date2026-02-27→2026-03-31
2026-02-23
minor
Study Status, Contacts/Locations v2
Start date2026-02-06→2026-02-27
Study sites2→5
2026-02-02
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-08-03→2027-08-23
Completion date2027-11-17→2027-12-08
Start date2025-12-17→2026-02-06
Study sites0→2
2025-11-14
minor
Original filing
148 trials monitored
See 16 trials at risk
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)
Trial Details
NCT Number NCT07235917
Lead Sponsor Regeneron Pharmaceuticals
Conditions Functional Hypothalamic Amenorrhea, FHA
Enrollment 34 participants
Start Date 2026-03-11
Primary Completion 2028-01-28 (estimated)
Study Completion 2028-05-17 (estimated)
Updated on ClinicalTrials.gov 2026-10-01