Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenPhase 1NCT05071729
A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work Normally
A Phase 1 study testing Elinzanetant (BAY3427080) in people with Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, run by Bayer at 2 sites in United States.
Trial summary
Researchers are looking for a better way to treat people who have vasomotor symptoms (VMS). The symptoms of VMS are hot flashes. These symptoms can be caused by changes in sex hormone levels. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
- What is being tested?
- Elinzanetant (BAY3427080)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Oct 2021to 19 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be 18 to 79 years of age inclusive, at the time of signing the informed consent.
- Moderate or severe renal impairment as assessed by estimated glomerular filtration rate (eGFR) based on serum creatinine collected 2 to 10 days prior to dosing and calculated according to a modified Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI). Moderately impaired renal function: eGFR: 30 up to 59 mL/min/1.73 m^2 (inclusive); Severely impaired renal function: eGFR < 30 mL/min/ 1.73 m^2 (including at least 50% patients requiring hemodialysis).
- Stable renal disease, i.e. a serum creatinine value determined 3 or more months before screening (e.g. during routine diagnostics) should not differ by more than 25% from the serum creatinine value determined at screening.
- Normal renal function, as assessed by eGFR based on serum creatinine at screening according to the modified CKD-EPI formula: eGFR ≥90 mL/min/1.73 m^2.
- Body mass index (BMI) within the range 18 - 32 kg/m^2 (inclusive).
- Male or female.
- Study participants of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period from signing of the informed consent form (ICF) until the follow-up visit on Day 6. Use of adequate contraception should be consistent with local regulations.
Who cannot join
- Any relevant disease (other than those related to renal impairment for the renal impaired participants) within 4 weeks prior to study drug administration including infections and acute gastro-intestinal diseases (with vomiting, diarrhea, constipation, etc.) requiring medical treatment.
- Acute renal failure or acute nephritis within the past 2 years.
- Malignancy diagnosed or treated within the past 5 years (hepatocellular carcinoma within the past 2 years). This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin.
- Conditions associated with a risk of hypersensitivity reactions with study intervention (active substances, or excipients of the preparations) as judged by the investigator.
- Dialysis for acute renal failure within the previous 6 months prior to administration of study intervention.
- Use of drugs which may affect absorption (e.g. loperamide, metoclopramide),and systemic administration of any broad-spectrum antibiotic within 1 week before study drug administration, unless the drug is part of the mandatory dosing regimen for treatment of renal impairment or related conditions.
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- Use of drugs which may affect absorption by increasing the gastro-intestinal pH e.g. proton pump inhibitors from 2 weeks before study drug administration until last day of blood sampling for PK after study drug administration.
- Use of anti-coagulant drugs other than 100 mg acetylsalicylic acid per day.
- Major change of any medication regimen less than 2 weeks prior to first study drug administration, including dose adjustments.
- Indication for immunosuppressants, receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy within 6 months prior to administration of study intervention
- Women of childbearing potential with a positive pregnancy test at screening or on Day -1.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Elinzanetant in Participants With Impaired Renal Function in Comparison to Matched Controls With Normal Renal Function
Researchers are looking for a better way to treat people who have vasomotor symptoms (VMS).
The symptoms of VMS are hot flashes. These symptoms can be caused by changes in sex hormone levels. An example of a change in sex hormone levels is when a woman reaches the time in their life where they no longer have their period. Hormones are substances in the blood that help body organs to work in specific ways. Women who no longer have their period may have a protein called neurokinin sending more signals than usual to other parts of the body. Researchers think that this may play a role in causing VMS.
Read more
In this study, the researchers want to learn more about a new substance called elinzanetant. Researchers think elinzanetant may help people with VMS. It works by blocking neurokinin from sending signals to other parts of the body. There are treatments available for VMS, but these do not work for all people and may cause medical problems for some people.
The main purpose of this study is to help the researchers learn more about how elinzanetant moves into, through and out of the body in participants with kidneys that do not work as well as they should compared to healthy participants whose kidneys work normally. To do this, the doctors will take blood samples from the participants at different times during the study and measure the levels of elinzanetant in the blood. This will help the researchers learn more about whether elinzanetant could be given to treat VMS in people who also have kidneys that do not work as well as they should.
This study will include adult participants who have kidneys that do not work as well as they should and participants whose kidneys work normally. The participants who have kidneys that do not work as well as they should will be split into 2 groups based on how severe their kidney problems are. All of the participants will take elinzanetant once as a tablet by mouth.
The participants will be in the study for about 1 month and will stay at their study site for 7 days in a row. During this visit, the participants will:
- have their overall health checked
- have scans of their heart taken using an electrocardiogram
- have blood and urine samples taken
- answer questions about how they are feeling, what medications they are taking, and what adverse events they are having
The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
- Being tested
- Elinzanetant (BAY3427080)
- Keywords
- Hot flushes, Elinzanetant, Investigation of pharmacokinetics and safety in renal impaired participants
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elinzanetant (BAY3427080)Drug
Single oral dose of elinzanetant on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Moderate renal impairment | Experimental | Participants with estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m^2 Receives: Drug: Elinzanetant (BAY3427080) |
| Severe renal impairment | Experimental | Participants with eGFR < 30 mL/min/ 1.73 m^2 Receives: Drug: Elinzanetant (BAY3427080) |
| Normal renal function | Experimental | Participants with ≥ 90 mL/min/1.73 m^2 Receives: Drug: Elinzanetant (BAY3427080) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration vs. time curve in plasma from zero to infinity (AUCu) (unbound)
Measured matrix after a single dose administration.
Measured: Predose up to 120 hours
Maximum observed (unbound) drug concentration (Cmax,u)
Maximum observed (unbound) drug concentration (Cmax,u) in measured matrix after a single dose administration.
Measured: Predose up to 120 hours
Secondary outcomes (1)
Number of participants with treatment-emergent adverse events, categorized by severity
Measured: After administration of study intervention up to the follow-up visit on Day 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start14 Oct 2021
- Primary completion19 Oct 2022
- Study completion19 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071729
- Sponsor's protocol ID
- 21669
- Status last verified
- Jul 2025
- First submitted
- 28 Sep 2021
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Elinzanetant in Participants With Impaired Renal Function in Comparison to Matched Controls With Normal Renal Function
- ClinicalTrials.gov ID
- NCT05071729
- Acronym / sponsor ID
- 21669
- Keywords
- Hot flushes, Elinzanetant, Investigation of pharmacokinetics and safety in renal impaired participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are looking for a better way to treat people who have vasomotor symptoms (VMS).
The symptoms of VMS are hot flashes. These symptoms can be caused by changes in sex hormone levels. An example of a change in sex hormone levels is when a woman reaches the time in their life where they no longer have their period. Hormones are substances in the blood that help body organs to work in specific ways. Women who no longer have their period may have a protein called neurokinin sending more signals than usual to other parts of the body. Researchers think that this may play a role in causing VMS.
In this study, the researchers want to learn more about a new substance called elinzanetant. Researchers think elinzanetant may help people with VMS. It works by blocking neurokinin from sending signals to other parts of the body. There are treatments available for VMS, but these do not work for all people and may cause medical problems for some people.
The main purpose of this study is to help the researchers learn more about how elinzanetant moves into, through and out of the body in participants with kidneys that do not work as well as they should compared to healthy participants whose kidneys work normally. To do this, the doctors will take blood samples from the participants at different times during the study and measure the levels of elinzanetant in the blood. This will help the researchers learn more about whether elinzanetant could be given to treat VMS in people who also have kidneys that do not work as well as they should.
This study will include adult participants who have kidneys that do not work as well as they should and participants whose kidneys work normally. The participants who have kidneys that do not work as well as they should will be split into 2 groups based on how severe their kidney problems are. All of the participants will take elinzanetant once as a tablet by mouth.
The participants will be in the study for about 1 month and will stay at their study site for 7 days in a row. During this visit, the participants will:
- have their overall health checked
- have scans of their heart taken using an electrocardiogram
- have blood and urine samples taken
- answer questions about how they are feeling, what medications they are taking, and what adverse events they are having
The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate renal impairment | Experimental | Drug: Elinzanetant (BAY3427080)Participants with estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m^2 |
| Severe renal impairment | Experimental | Drug: Elinzanetant (BAY3427080)Participants with eGFR < 30 mL/min/ 1.73 m^2 |
| Normal renal function | Experimental | Drug: Elinzanetant (BAY3427080)Participants with ≥ 90 mL/min/1.73 m^2 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant must be 18 to 79 years of age inclusive, at the time of signing the informed consent.
- Moderate or severe renal impairment as assessed by estimated glomerular filtration rate (eGFR) based on serum creatinine collected 2 to 10 days prior to dosing and calculated according to a modified Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI). Moderately impaired renal function: eGFR: 30 up to 59 mL/min/1.73 m^2 (inclusive); Severely impaired renal function: eGFR < 30 mL/min/ 1.73 m^2 (including at least 50% patients requiring hemodialysis).
- Stable renal disease, i.e. a serum creatinine value determined 3 or more months before screening (e.g. during routine diagnostics) should not differ by more than 25% from the serum creatinine value determined at screening.
- Normal renal function, as assessed by eGFR based on serum creatinine at screening according to the modified CKD-EPI formula: eGFR ≥90 mL/min/1.73 m^2.
- Body mass index (BMI) within the range 18 - 32 kg/m^2 (inclusive).
Key exclusion criteria (11 listed)
- Any relevant disease (other than those related to renal impairment for the renal impaired participants) within 4 weeks prior to study drug administration including infections and acute gastro-intestinal diseases (with vomiting, diarrhea, constipation, etc.) requiring medical treatment.
- Acute renal failure or acute nephritis within the past 2 years.
- Malignancy diagnosed or treated within the past 5 years (hepatocellular carcinoma within the past 2 years). This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin.
- Conditions associated with a risk of hypersensitivity reactions with study intervention (active substances, or excipients of the preparations) as judged by the investigator.
- Dialysis for acute renal failure within the previous 6 months prior to administration of study intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elinzanetant (BAY3427080)Single oral dose of elinzanetant on Day 1. | Drug | Moderate renal impairment, Normal renal function, Severe renal impairment |
Primary outcome
Area under the concentration vs. time curve in plasma from zero to infinity (AUCu) (unbound)
Time frame: Predose up to 120 hours
Measured matrix after a single dose administration.
Maximum observed (unbound) drug concentration (Cmax,u)
Time frame: Predose up to 120 hours
Maximum observed (unbound) drug concentration (Cmax,u) in measured matrix after a single dose administration.
1 secondary outcome
Number of participants with treatment-emergent adverse events, categorized by severity
Time frame: After administration of study intervention up to the follow-up visit on Day 6.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elinzanetant (BAY3427080) in people with Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, run by Bayer at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration vs. time curve in plasma from zero to infinity (AUCu) (unbound) (time frame: Predose up to 120 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.