Elinzanetant for menopausal hot flashes and heart health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study in peri- and post-menopausal women with moderate to severe vasomotor symptoms aims to see if elinzanetant, a neurokinin receptor antagonist, can improve vascular health compared to placebo. Eligible participants are adults aged 40–65 with cardiometabolic risk factors. The trial compares elinzanetant to placebo and will monitor safety and vascular outcomes over a defined period. Conducted at Massachusetts General Hospital and Brigham and Women's Hospital, it excludes individuals with significant comorbidities or liver dysfunction. The study is sponsored by Massachusetts General Hospital with no listed collaborators.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Emily Lau, MD, MPH — Massachusetts General Hospital
• Study coordinator: Kamila Bielawski
• Email: mghflashcv@mgb.org
• Phone: 617-724-3064

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tirzepatide for hot flashes and biological aging in postmenopausal women with obesity

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• Improving midlife women's health during the menopausal transition

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.