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The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity

Plain-language guide to NCT07218445: phase 4 randomized trial of Tirzepatide, 40 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07218445
Phase
phase 4
Status
recruiting participants
Start
2026-04-08
Completion (planned or actual)
2027-09-18
Participants
40 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Obesity; Menopause Hot Flashes
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around Tirzepatide.

The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.

It had two arms (groups): Tirzepatide (experimental) and Placebo (placebo comparator).

Participants will receive tirzepatide for 24 weeks, in addition to standard lifestyle modification recommendations.

Participants will receive a placebo for 24 weeks, in addition to standard lifestyle modification recommendations.

The registry classes the interventions as drug.

Who Took Part

40 planned participants were the target.

It was open to women only aged from 46 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 46-60 years old. BMI ≥30 kg/m2 or BMI ≥27 kg/m2 in the presence of adiposity-associated diseases (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease). Presence of bothersome hot flashes (an average of ≥ 28 episodes during a consecutive 2-week period with symptom severity sufficient to have prompted the participant to seek therapeutic treatment). Hot flashes must be present for \>30 days prior to study entry. Willingness to self-inject drug.

The full record lists 8 inclusion and 18 exclusion criteria; among the exclusions: current or recent use (past 4 weeks) treatment with menopausal hormone therapy; any current, recent use (past 4 weeks), or planned use of:; vaginal estrogen.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-04-08 with completion listed for 2027-09-18.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Vasomotor Symptoms Frequency (time frame: Baseline, 24 weeks). Change in Vasomotor Symptom Severity (time frame: Baseline, 24 weeks). Aging Biomarkers: Cellular Senescence Markers in Plasma (time frame: 24 weeks).

It also tracked 14 secondary outcomes, for example Change in Reactive hyperemic index, Change in Augmentation Index percentage, Change in Pulse Wave Velocity, Change in Cardiometabolic Parameters: Blood Pressure, Change in Cardiometabolic Parameters: Fasting Glucose and Changes in Cardiometabolic Parameters: HbA1C.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Tirzepatide in 40 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.

Our Notes on the Compound

Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.