RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT07235917

Registry updated: 2026-10-01

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Description

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)

Interventions

Mibavademab (Drug)
Administered per the protocol
Placebo (Other)
Administered per the protocol

Eligibility criteria

Key Inclusion Criteria: 1. Diagnosis of FHA after exclusion of anatomic or organic causes of amenorrhea 2. Has had no menstrual bleeding episode within 3 months prior to day 1, as described in the protocol 3. Has a Body Mass Index (BMI) ≥18.5 and \<25 kg/m\^2 at screening, or BMI ≥25 to \<30 kg/m\^2 at screening AND percentage of body fat \<23% from rigorous exercise as determined by the investigator through Standard of Care (SoC) methods (eg, skinfold thickness, DXA, bioimpedance) within 6 months of screening Key Exclusion Criteria: 1. Has presence of primary amenorrhea (failure to reach menarche, first menstrual cycle) 2. Has blood estradiol ≥50 pg/mL or blood progesterone ≥1 ng/mL at screening, as described in the protocol 3. Has uterine (eg, absence of uterus, prior endometrial ablation, endometriosis, outflow tract disorders) or ovarian conditions (eg, absence of an ovary, presence of large polycystic ovaries i.e. greater than 10 cc) that impact assessment of menses or of the HPO axis 4. Has conditions other than FHA that may cause amenorrhea or menstrual cycle disturbances (eg, polycystic ovarian syndrome, hyperprolactinemia, primary ovarian insufficiency, untreated primary hypothyroidism, primary hyperthyroidism), as described in the protocol 5. Polycystic ovarian morphology with an ovarian volume \>10 cc on TransVaginal UltraSound (TVUS) \[or TransAbdominal Pelvic Ultrasound (TAPU) if applicable\] at baseline 6. Presence of follicle ≥17 mm, evidence of ruptured follicle, and/or evidence of corpus luteum on TVUS (or TAPU if applicable) at baseline NOTE: Other protocol-defined Inclusion/Exclusion criteria apply

Conditions

Functional Hypothalamic Amenorrhea FHA

Locations

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
University of Pittsburgh — Pittsburgh, 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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