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

NCT07235917 | Recruiting Phase 2 FDA Drug

• 1 other identifier: R4461-FHA-2485
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 6

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)

Keywords

Secondary amenorrhea; Hypothalamic-Pituitary-Ovarian (HPO) axis; Group I ovulation disorder; Hypogonadotropic hypogonadal anovulation

Outcome Measures

Primary Outcomes (1)

• Change from the highest serum estradiol observed during a 28-day period

  Baseline to month 6

Secondary Outcomes (20)

• Change from the mean serum estradiol observed during a 28-day period

  Baseline to month 6

• Occurrence of menses followed by mid-cycle serum estradiol ≥200 pg/ml and mid-luteal serum progesterone ≥7.9 ng/ml

  At month 6

• Change in the highest serum estradiol

  Baseline through 6 months

• Occurrence of serum estradiol ≥200 pg/ml

  Through 6 months

• Number of ovulatory menstrual cycles

  Through 6 months

Study Arms (2)

Mibavademab

EXPERIMENTAL

Drug: Mibavademab

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Mibavademab DRUG

Administered per the protocol

Also known as: REGN4461

Mibavademab

Placebo OTHER

Administered per the protocol

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Has had no menstrual bleeding episode within 3 months (or longer) prior to day 1, as described in the protocol
• 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

You may not qualify if:

• Has presence of primary amenorrhea (failure to reach menarche, first menstrual cycle)
• Has blood estradiol ≥50 pg/mL or blood progesterone ≥1 ng/mL at screening
• 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
• 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)
• Polycystic ovarian morphology with an ovarian volume \>10 cc on TransVaginal UltraSound (TVUS) \[or TransAbdominal Pelvic Ultrasound (TAPU) if applicable\] at baseline
• Presence of follicle ≥17 mm, evidence of ruptured follicle, and/or evidence of corpus luteum on TVUS (or TAPU if applicable) at baseline

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (6)

Arensia Exploratory Medicine Clinic

Phoenix, Arizona, 85015, United States

RECRUITING

Focus Clinical Research

West Hills, California, 91307, United States

RECRUITING

Oregon Health and Science University (OHSU)

Portland, Oregon, 97239, United States

RECRUITING

OBGYN Associates of Erie

Erie, Pennsylvania, 16507, United States

RECRUITING

Zillan Clinical Research

Houston, Texas, 77082, United States

RECRUITING

Tidewater Clinical Research - Tidewater Physicians for Women

Norfolk, Virginia, 23502, United States

RECRUITING

Related Links

• Related Info

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: March 11, 2026
• Primary Completion (Estimated): August 20, 2027
• Study Completion (Estimated): December 8, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (6)