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

NCT ID: NCT07235917

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-17
• Study Completion Date: 2027-11-17

Brief 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)

Conditions

Functional Hypothalamic Amenorrhea (FHA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Mibavademab

Group Type: EXPERIMENTAL

Mibavademab

Intervention Type: DRUG

Administered per the protocol

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Administered per the protocol

Interventions

Mibavademab

Administered per the protocol

Intervention Type: DRUG

Placebo

Administered per the protocol

Intervention Type: OTHER

Other Intervention Names

REGN4461

Eligibility Criteria

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 (or longer) 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 <20% from rigorous exercise as determined by the investigator through Standard of Care (SoC) methods (eg, skinfold thickness, DXA, bioimpedance) within 6 months of screening, as described in the protocol

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

3. Has uterine (eg, absence of uterus, prior endometrial ablation, endometriosis, outflow tract disorders) or ovarian (eg, absence of an ovary, presence of polycystic ovaries) conditions 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)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Central Contacts

Clinical Trials Administrator

Role: CONTACT

clinicaltrials@regeneron.com

844-734-6643

Other Identifiers

R4461-FHA-2485

Identifier Type: -

Identifier Source: org_study_id