Home › Hot Flashes › NCT07077395
Finding Links Between Hot flASHes and CardioVascular Disease
RecruitingPhase 2
Who can join
Ages 40 to 65 · Women
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
About the study
The goal of this clinical trial is to learn if neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improves blood vessel health in women with moderate to severe hot flashes. The main questions it aims to answer is does neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improve blood vessel health?
What is being tested
- elinzanetant - reference formulation (drug)
- placebo (drug)
Sponsor: Massachusetts General Hospital · Participants: 80 · Started: Mar 1, 2026
Contact the study team
- Kamila Bielawski · Phone: 617-724-3064
Official record on ClinicalTrials.gov — NCT07077395
Locations in the U.S.
| Massachusetts | Brigham and Women's Hospital, Boston Massachusetts General Hospital, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.