Finding Links Between Hot flASHes and CardioVascular Disease (FLASH-CV:)

Mass General Brigham

Status and phase

Not yet enrolling

Phase 2

Conditions

Menopause-related Hot Flashes

Treatments

Drug: placebo

Drug: elinzanetant - reference formulation

Study type

Interventional

Funder types

Other

Identifiers

NCT07077395

2025p001738

Details and patient eligibility

About

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?

Enrollment

80 estimated patients

Sex

Female

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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