Elinzanetant for Hot Flashes and Blood Vessel Health

This study is looking at whether elinzanetant, a drug that blocks certain brain signals (neurokinin-1/neurokinin-3 receptor antagonist), can improve blood vessel health in women who have moderate to severe hot flashes related to menopause. You may be able to join if you are a woman between 40 and 65 years old, are going through or have gone through menopause, and have moderate to severe hot flashes. You also need to have certain health conditions like obesity or high triglycerides (a type of fat in the blood). The study will measure changes in your blood vessels after 12 weeks to see if elinzanetant is helpful. We don't know the current enrollment status.

Study design
This interventional study plans to enroll 80 participants. It compares elinzanetant to a placebo (an inactive substance) over 12 weeks.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Blood vessel health will be measured at 12 weeks after starting treatment.

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NCT07077395

Finding Links Between Hot flASHes and CardioVascular Disease

Recruiting
PHASE2Ages 40–65InterventionalTreatment
Massachusetts General Hospital
~80 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:elinzanetant - reference formulationplacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
brachial artery flow mediated dilation
Measured over 12 weeks
Menopause-related Hot Flashes
2 sites across 1 states
Massachusetts2
  • Emily Lau, MD, MPH · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

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Eligibility criteria

Inclusion

Age 40-65 years
Peri- and post-menopausal women (STRAW -1 to +1)
Moderate or high vasmotor symptom burden
Cardiometabolic disease (as evidenced by ≥ 2 of the following):
Obesity (body mass index ≥ 30 kg/m2)
Elevated waist circumference (≥ 88 cm)
Elevated triglycerides (≥ 150 mg/dL or drug treatment)
Reduced HDL-cholesterol (\<50 mg/dL or drug treatment)
Elevated blood pressure (≥ 130 mmHg systolic blood pressure or ≥ 85 mmHg diastolic blood pressure, or drug treatment)
Elevated fasting glucose (≥ 100 mg/dL or drug treatment)

Exclusion

Inability to provide informed consent or comply with study protocol
Major comorbidities: cancer, end-stage renal (eGFR \<45 mL/min/1.73 m2), liver or lung disease
Concomitant use of strong or moderate cytochrome P450 3A4 inhibitors
Elevated liver function tests (ALT, AST, and/or total bilirubin ≥2x ULN)
Undiagnosed uterine bleeding over past 6 months
  • brachial artery flow mediated dilation12 weeks