Mibavademab for Amenorrhea
(KYRIAD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an experimental drug, mibavademab, to determine if it can help women with Functional Hypothalamic Amenorrhea (FHA) resume menstruation. FHA occurs when the brain fails to send the correct signals to the ovaries, halting periods. Researchers aim to assess whether mibavademab can improve reproductive hormone levels and evaluate its safety. Women who have not had a period for at least three months and lack other conditions causing missed periods may qualify for this study. As a Phase 2 trial, this research measures mibavademab's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that mibavademab is likely to be safe for humans?
Research shows that mibavademab is under investigation for its safety and effectiveness in treating Functional Hypothalamic Amenorrhea (FHA). Earlier studies tested mibavademab for other conditions, such as generalized lipodystrophy, and found it to be reasonably safe. Mibavademab activates leptin receptors, and patients generally tolerated it well.
Some side effects were reported, mostly mild to moderate, such as minor injection site reactions or mild headaches. Serious side effects were rare in those studies. However, treatments can affect people differently.
The current study is in phase 2, indicating some initial safety data from earlier trials, but researchers continue to monitor for any side effects. This phase aims to gather more detailed safety information from a larger group. If considering joining the trial, discussing it with the study team or a healthcare provider can help in making an informed decision.12345Why do researchers think this study treatment might be promising for amenorrhea?
Most treatments for amenorrhea, like hormonal therapies, aim to balance hormone levels to restore menstrual cycles. But Mibavademab works differently, targeting specific pathways associated with amenorrhea that aren't addressed by standard hormone treatments. Researchers are excited about Mibavademab because it offers a novel mechanism of action that could provide relief for patients who don't respond well to traditional therapies. With its unique approach, Mibavademab has the potential to open new doors in amenorrhea treatment, offering hope for more personalized and effective care.
What evidence suggests that mibavademab might be an effective treatment for amenorrhea?
Research suggests that mibavademab, which participants in this trial may receive, might help treat Functional Hypothalamic Amenorrhea (FHA) by encouraging the body to produce the hormones needed for ovulation. Previous studies have shown that mibavademab, acting like the hormone leptin, can help balance hormones and improve energy use in the body. Early research also found that this treatment might help manage body weight and control blood sugar levels, both important for reproductive health. While more studies are needed to confirm these benefits specifically for FHA, mibavademab shows promise in addressing the hormonal imbalances related to this condition.15678
Who Is on the Research Team?
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adult women with Functional Hypothalamic Amenorrhea (FHA), which means they've stopped having periods due to hormonal signaling issues between the brain and ovaries. Participants should have a BMI of at least 18.5 but less than 30, and if it's over 25, their body fat must be under 20% from exercise. They shouldn't have had a menstrual cycle in the last three months.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mibavademab or placebo to assess its effects on hormone production and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mibavademab
Trial Overview
The study tests Mibavademab, an experimental drug, against a placebo to see if it can help restore hormone production needed for ovulation and menstruation in women with FHA. It also looks into its effects on bone health, potential side effects, how much of the drug stays in the blood over time, and whether the body creates antibodies against it.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Citations
NCT07235917 | A Study to Investigate Mibavademab in ...
The study is focused on patients with a condition called Functional Hypothalamic Amenorrhea (FHA). FHA is a condition where a woman stops menstruating because ...
2.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/REGN/pressreleases/50304/regeneron-broadens-womens-health-pipeline-with-new-phase-2-fha-trial/Regeneron Broadens Women's Health Pipeline With New ...
The study of mibavademab in functional hypothalamic amenorrhea is ongoing and recently updated, with full details available on the ...
FRI058 Treatment With Mibavademab, A Novel Leptin ... - PMC
After 8 weeks of low-dose mibavademab, drug levels were significantly lower than predicted in the active arm, and clinically meaningful ...
Pharmacokinetics and pharmacodynamics of mibavademab ...
Study Highlights Previous studies have demonstrated that mibavademab treatment effectively reduces body weight, improves glycemic control and ...
5.
synapse.patsnap.com
synapse.patsnap.com/article/what-clinical-trials-have-been-conducted-for-mibavademabWhat clinical trials have been conducted for Mibavademab?
Outcomes from this trial will determine whether the leptin receptor agonist can reliably control metabolic abnormalities with an acceptable ...
6.
trial.medpath.com
trial.medpath.com/news/4a38369f700a2670/regeneron-advances-phase-2-trial-of-mibavademab-for-functional-hypothalamic-amenorrheaRegeneron Advances Phase 2 Trial of Mibavademab for ...
The Phase 2 study, formally titled "A Phase 2, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of MibavademabView ...
7.
clinicalstudies.info.nih.gov
clinicalstudies.info.nih.gov/protocoldetails.aspx?id=002207-DK&&query=1%20OpenNIH Clinical Center: Search the Studies
A Single Arm, Open Label, Safety Study in Patients with Generalized Lipodystrophy Switching from Metreleptin to Mibavademab, A Leptin Receptor Agonist Antibody.
8.
ctv.veeva.com
ctv.veeva.com/study/efficacy-and-safety-of-mibavademab-in-adult-and-pediatric-patients-with-generalized-lipodystrophyEfficacy and Safety of Mibavademab in Adult and Pediatric ...
This is a 2-part study: Part A is an efficacy study in pediatric and adult participants, Part B is a safety and pharmacokinetic study in ...
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