Elinzanetant for Hot Flashes

No longer recruiting at 149 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Bayer

Must not be taking: Adjuvant endocrine therapy

Disqualifiers: Arrhythmias, Malignancy, Hypertension, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called elinzanetant to help women who experience hot flashes after menopause, the time when menstrual periods stop. Elinzanetant aims to reduce hot flashes by blocking certain signals in the body that trigger them. Participants will take either elinzanetant or a placebo (a harmless pill with no active medicine) to evaluate the treatment's effectiveness. Women who have gone through menopause and experience moderate to severe hot flashes may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, the doctors will ask about the medicines you are taking, so it's best to discuss your specific situation with them.

Is there any evidence suggesting that elinzanetant is likely to be safe for humans?

Research has shown that elinzanetant is generally safe and well-tolerated. In earlier studies, only a few participants experienced serious side effects. Most side effects were mild, such as headaches or nausea, and affected only a small number of people. Importantly, researchers have tested the treatment for up to 52 weeks, gathering extensive safety information. Additionally, the FDA has approved elinzanetant for treating symptoms like hot flashes, indicating it meets safety standards for human use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hot flashes?

Elinzanetant is unique because it targets neurokinin receptors to alleviate hot flashes, which is different from the typical hormone replacement therapies that use estrogen. This new mechanism of action is promising because it offers a non-hormonal option, potentially reducing the risks associated with hormone-based treatments. Researchers are excited about elinzanetant as it provides a fresh approach for managing menopause-related symptoms, which could be particularly beneficial for women who cannot or prefer not to use hormone therapy.

What evidence suggests that elinzanetant might be an effective treatment for hot flashes?

Studies have shown that elinzanetant can effectively reduce the number and severity of hot flashes in postmenopausal women. In one study, over 70% of participants taking elinzanetant reported their symptoms were halved after 12 weeks. Additionally, elinzanetant has been linked to better sleep and improved overall quality of life during menopause compared to a placebo. In this trial, participants will receive either elinzanetant alone or a placebo followed by elinzanetant. The treatment blocks a protein called neurokinin, which is believed to cause hot flashes. These findings suggest that elinzanetant may be a promising option for managing troublesome hot flashes in menopausal women. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or at least 6 months of spontaneous amenorrhea prior to signing of informed consent with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or at least 6 months after hysterectomy at signing of informed consent with serum FSH levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks prior to signing of informed consent.

Postmenopausal, defined as:

Participant has completed Hot Flash Daily Diary (HFDD) for at least 11 days during the two weeks preceding baseline visit, and participant has recorded at least 50 moderate or severe HF (including night-time HF) over the last 7 days that the HFDD was completed (assessed at the Baseline Visit).

Exclusion Criteria

Uncontrolled or treatment-resistant hypertension. Women with mild hypertension can be included in the study if they are medically cleared prior to study participation.

Untreated hyperthyroidism or hypothyroidism.

Treated hyperthyroidism with no abnormal increase of thyroid function laboratory parameters and no relevant clinical signs for > 6 months before signing of informed consent is acceptable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either elinzanetant or placebo for 26 weeks. Placebo group switches to elinzanetant after 12 weeks.

26 weeks

9 visits (in-person), 1 visit (phone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Elinzanetant

How Is the Trial Designed?

Group I: Elinzanetant (BAY3427080) Experimental Treatment 1 Intervention

Participants will receive 120 mg elinzanetant orally once daily for 26 weeks.

Group II: Placebo + elinzanetant Placebo Group 2 Interventions

Participants will receive matching placebo orally once daily for 12 weeks, followed by elinzanetant 120 mg for 14 weeks.

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Citations

1.

ajmc.com

ajmc.com/view/elinzanetant-shows-consistent-efficacy-safety-and-sleep-benefits-across-studies

Elinzanetant Shows Consistent Efficacy, Safety, and Sleep ...

Elinzanetant 120 mg consistently reduced daily VMS frequency and severity and improved sleep quality from baseline to week 12, with greater mean ...

2.

jamanetwork.com

jamanetwork.com/journals/jamainternalmedicine/fullarticle/2838538

Elinzanetant for the Treatment of Vasomotor Symptoms ...

Elinzanetant also resulted in statistically significant improvements in sleep disturbances and menopause-related quality of life vs placebo at ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12418220/

Elinzanetant for the Treatment of Vasomotor Symptoms ...

Elinzanetant also resulted in statistically significant improvements in sleep disturbances and menopause-related quality of life vs placebo at ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03596762

NCT03596762 | A Study of BAY3427080 (NT-814) in the ...

The purpose of this study is to determine the effectiveness of BAY3427080 (NT-814), taken once a day, in the treatment of troublesome post-menopausal symptoms.

5.

nejm.org

nejm.org/doi/10.1056/NEJMoa2415566

Elinzanetant for Vasomotor Symptoms from Endocrine ...

In exploratory analyses, more than 70% of the participants treated with elinzanetant had a reduction in symptoms of at least 50% at 12 weeks, ...

6.

bayer.com

bayer.com/en/us/news-stories/lynkuet

Bayer's Lynkuet® (elinzanetant), the First and Only ...

The FDA approval is supported by data from three Phase III clinical trials (OASIS 1, OASIS 2 and OASIS 3) that evaluated the safety and efficacy ...

7.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2025/219469s000lbl.pdf

LYNKUET® (elinzanetant) capsules, for oral use

There are no data on the use of LYNKUET in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or ...

8.

abmole.com

abmole.com/literature/elinzanetant-msds.html?srsltid=AfmBOoqWc2jjLIJTrBB70C976kwixBBUCKv5F1Ud88N0c1sT4T_tir92

Material Safety Data Sheet of Elinzanetant

Material Safety Data Sheet of Elinzanetant contains identification of substance and details of the supplier of the safety data sheet.