Recruiting
Phase 2

Elinzanetant

Sponsor:

Massachusetts General Hospital

Code:

NCT07077395

Conditions

Menopause-related Hot Flashes

Eligibility Criteria

Sex: Female

Age: 40 - 65

Healthy Volunteers: Not accepted

Interventions

elinzanetant - reference formulation

placebo

Study Details

Brief summary:

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?

Conditions

Menopause-related Hot Flashes

Study ID

NCT07077395

Start date

Mar 1, 2026

Status verified date

May, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: elinzanetant 120 mg daily for 12 weeks

placebo comparator: Placebo daily for 12 weeks

Interventions

elinzanetant - reference formulation

elinzanetant 120 mg daily x 12 weeks

placebo

placebo daily x 12 weeks

Primary outcome measure

  • brachial artery flow mediated dilation [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Kamila Bielawski

617-724-3064mghflashcv@mgb.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Kamila Bielawski

617-724-3064mghflashcv@mgb.org

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Kamila Bielawski

617-643-6161mghflashcv@mgb.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

  • menopause
  • hot flashes
  • heart health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-20.