Clinical Trials & Pipeline
Clinical Trials & Pipeline
At Bayer, our focus is to discover and develop medicines that provide the opportunity to live a healthier life. We are actively pursuing our vision to deliver best-in-class patient care, outcomes, and experience by advancing science.
Information on investigational compounds and clinical trials sponsored by Bayer is made available here to increase the transparency of Bayer's clinical research. Below you can learn more about trials sponsored by Bayer. Research sponsored by independent investigators is not included.
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Ongoing Trials
OASIS-4
A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer
STUDY DESIGN
Double-blind, Randomized, Placebo-controlled Multicenter Study
Treatment:
- Participants will take Elinzanetant
- Participants will take Elinzanetant matching placebo
STUDY POPULATION
- N=473 (sites located in Canada, Europe and Asia)
Inclusion criteria:
- Females aged 18 to 70 years of age inclusive, at the time of signing the informed consent.
- Women experiencing vasomotor symptoms (VMS) caused by adjuvant endocrine therapy that they are expected to use for the duration of the study
- Tamoxifen with or without the use of gonadotropin-releasing hormone (GnRH) analogues or
- Aromatase inhibitors with or without the use of GnRH analogues
- Women must have
- a personal history of hormone-receptor positive breast cancer or
- a high risk for developing breast cancer.
- 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 35 moderate to severe hot flash (HF) (including night-time HF) over the last 7 days that the HFDD was completed (assessed at the Baseline Visit).
- Contraceptive use by [women except for post-menopausal women or Women of Non childbearing potential (WONCBP)] should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria:
- Initial diagnosis of metastatic hormone-receptor positive breast cancer (stage IV) or recurrence under adjuvant endocrine therapy of hormone-receptor positive breast cancer.
- Current or history (except complete remission for 5 years or more prior to signing informed consent) of any malignancy, except for hormone-receptor positive breast cancer (Stage 0-III), basal and squamous cell skin tumors.
- Surgery or non-surgical (e.g., chemotherapy, radiotherapy, immunotherapy) treatment for breast cancer within the last 3 months prior to signing informed consent (except use of tamoxifen, aromatase inhibitors, GnRH analogues).
- Any clinically significant prior or ongoing history of arrhythmias, heart block and QT prolongation either determined through clinical history or on electrocardiogram (ECG) evaluation.
- Any active ongoing condition that could cause difficulty in interpreting VMS such as: infection that could cause pyrexia, pheochromocytoma, carcinoid syndrome.
- Any unexplained vaginal bleeding.
- Mammogram with clinically relevant malignant or suspicious findings that will require surgery, radiotherapy or chemotherapy as per local guidelines (mammogram should not be older than 12 months prior to signing informed consent). If a mammogram is not possible after partial mastectomy an ultrasound could be performed instead.
- Disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer diagnosed based on endometrial biopsy during screening.
- Current arterial or venous vascular event (e.g., Myocardial infarction (MI), Transient ischemic attack (TIA), stroke, deep vein thrombosis (DVT), i.e., within the last 6 months prior to signing informed consent.
ENDPOINTS
Primary Endpoint:
Mean change in frequency of moderate to severe hot flash (HF) as measured by HFDD
Timeframe: Baseline to week 4, baseline to week 12
Secondary Endpoints:
Mean change in severity of moderate to severe HF as measured by HFDD
Timeframe: Baseline to week 4, baseline to week 12
Mean change in frequency of moderate to severe HF from baseline over time as measured by HDFF
Timeframe: Baseline to week 1, baseline to week 52
Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score
The PROMIS SD SF 8b includes 8 items assessing sleep disturbance over the past 7 days. Items assess sleep quality, sleep depth and restoration associated with sleep, perceived difficulties with getting to sleep or staying asleep and perceptions of the adequacy of and satisfaction with sleep. Participants respond to the items on a 5-point scale from not at all, never or very poor to very much, always or very good. Four of the items are scored reversely. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance.
Timeframe: Baseline to Week 12
Mean change in menopause specific quality of life scale (MENQOL) total score
The MENQOL questionnaire is comprised of 29 items assessing the presence of menopausal symptoms and the impact of menopause on health-related quality of life over the past week. The items assess four domains of symptoms and functioning: VMS, psychosocial functioning, physical functioning, and sexual functioning. For each item, the participant indicates if they have experienced the symptom (yes/no). If participants select yes, participants rate how bothered they were by the symptom using a six-point verbal descriptor scale, with response options ranging from 0 'not at all bothered' to 6 'extremely bothered'. Based on the individual responses, item scores, domain scores, and a total MENQOL score are calculated. Each score ranges from 1-8, higher scores indicate greater bother.
Timeframe: Baseline to Week 12
NCT05587296
Acronyms:
HF: Hot Flash
HFDD: Hot Flash Daily Diary
MENQOL: menopause specific quality of life scale
PROMIS SD SF 8b: Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b
NIRVANA
A study to learn about how Elinzanetant affects sleep disturbances associated with menopause, measured with a sleep test called polysomnography (PSG), vs. placebo.
STUDY DESIGN
Randomized, Parallel-group Treatment, Double-blind, Placebo Controlled
Treatment:
- Participants will take Elinzanetant
- Participants will take Elinzanetant matching placebo
STUDY POPULATION
- N=78 (estimated)
Inclusion criteria:
- Females aged 40 to 65 years, inclusive, at signing of informed consent.
- Being in the post-menopausal period, defined as: serum FSH levels >40 mIU/mL and a serum estradiol concentration of <30 pg/mL at screening, AND Hysterectomy performed at least 6 weeks prior to screening.
- The participant’s self-reported sleep history includes ongoing sleep disturbances associated with menopause characterized by waking up at night and/or poor quality of sleep.
- WASO [Wakefulness After Sleep Onset] of 30 minutes or more (mean of 2 screening PSGs with neither of the 2 nights <20 min).
Exclusion criteria:
- Medical history, or baseline PSG assessment, includes a diagnosis of a sleep disorder other than sleep disturbances associated with the menopause (e.g., sleep apnea, restless leg syndrome, circadian rhythm sleep disorder).
- Current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors).
- Renal impairment greater than moderate (i.e. estimated glomerular filtration rate <30 mL/min/1.73 m2) at screening.
ENDPOINTS
Primary Endpoint:
Change from baseline in WASO as measured by PSG
WASO: Wakefulness after sleep onset – total number of minutes that a participant is awake after having initially fallen asleep.
PSG assessments will be performed on 2 consecutive nights.
Timeframe: At Week 4
Secondary Endpoints:
Change from baseline in WASO as measured by PSG
PSG assessments will be performed on 2 consecutive nights.
Timeframe: At Week 12
Change from baseline in SE as measured by PSG
SE: Sleep Efficiency – ratio between the total time a participant is asleep (TST) to the total time spent in bed. Presented as a percentage.
Timeframe: At Week 4 & Week 12
Change from baseline in PROMIS SD SF 8b total score
PROMIS SD SF 8b: Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b. The PROMIS SD SF 8b includes 8 items assessing sleep disturbance over the past 7 days. Items assess sleep quality, sleep depth and restoration associated with sleep, perceived difficulties with getting to sleep or staying asleep and perceptions of the adequacy of and satisfaction with sleep. Participants respond to the items on a 5-point scale from not at all, never or very poor to very much, always or very good. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance.
Timeframe: At Week 4 & Week 12
Change from baseline in ISI (Insomnia Severity Index) total score
The ISI is a 7 item instrument that quantifies the participant perception of insomnia severity, along with the impact of insomnia on daytime functioning in adults in the last 2 weeks. The items refer to: severity of sleep onset, sleep maintenance and early morning wakening problems, satisfaction with sleep pattern, noticeability of sleep problems by others, distress caused by the sleep difficulties and interference of sleep difficulties with daytime functioning. It is scored on a 5 point Likert scale from 0 to 4 depending on the item (0="none", 4="very severe" (Items 1–3); 0="very satisfied", 4="very dissatisfied" (Item 4); 0="not at all noticeable", 4="very much noticeable" (Item 5); 0="not at all worried", and 4="very much worried" (Item 6); 0="not at all interfering", 4="very much interfering" (Item 7)). The scores for each item are summed to produce the total score (maximum 28), higher scores indicates greater severity.
Timeframe: At Week 4 & Week 12
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to 16 weeks
Number of participants with Abnormal laboratory parameters
Timeframe: Up to 13 weeks
NCT06112756
Acronyms:
ISI: Insomnia Severity Index
PROMIS SD SF 8b: Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b
SE: Sleep Efficiency – ratio between the total time a participant is asleep (TST) to the total time spent in bed
WASO: Wakefulness after sleep onset – total number of minutes that a participant is awake after having initially fallen asleep
TEAEs: Treatment-emergent Adverse Events
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