RecruitingPhase 2NCT07235917

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

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

Enrollment

34 participants

Start Date

Mar 11, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is researching an experimental drug called mibavademab (also called "study drug"). The study is focused on patients 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 drug less effective or could lead to side effects)


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Mibavademab and Placebo for people with functional hypothalamic amenorrhea (fha). The study is currently recruiting participants at 8 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMibavademab

Administered per the protocol

OTHERPlacebo

Administered per the protocol


Locations(10)

Arensia Exploratory Medicine Clinic

Phoenix, Arizona, United States

Focus Clinical Research

West Hills, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Oregon Health and Science University (OHSU)

Portland, Oregon, United States

OBGYN Associates of Erie

Erie, Pennsylvania, United States

Penn State Health Milton South Hershey Medical Center

Hershey, Pennsylvania, United States

Zillan Clinical Research

Houston, Texas, United States

University of Virginia School of Medicine

Charlottesville, Virginia, United States

Tidewater Clinical Research - Tidewater Physicians for Women

Norfolk, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07235917