Finding Links Between Hot flASHes and CardioVascular Disease

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?

Recruiting

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Key information

Conditions

Menopause-related Hot Flashes Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

elinzanetant - reference formulation

Drug

elinzanetant 120 mg daily x 12 weeks

Placebo

Drug

placebo daily x 12 weeks

Primary outcomes

brachial artery flow mediated dilation

Time frame: 12 weeks

Secondary outcomes

concentration of inflammatory protein biomarkers

Time frame: 12 weeks
- General inflammatory markers: hsCRP, IL-8, TNF-ɑ/β
- Leukocyte adhesion markers: MCP-1, ICAM-1
- Markers of vascular homeostasis: ANGPT1, VEGFA, HB-EGF

Study contacts

Contact information is provided by the study sponsor or research team.

Kamila Bielawski

CONTACT

[email protected]

617-724-3064

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: FLASH-CV:

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Jul 22, 2025
Registry last updated: May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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