Focusing on the Menopausal Transition to Improve Mid-Life Women's Health

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Semaglutide.

It had five arms (groups): one (experimental), At Risk for Heart Disease (active comparator), Overweight Women (active comparator), Women with Obesity (active comparator) and Women With Hot Flashes (active comparator).

Medications will be given to each participant in this arm that lowers your heart disease risk.

Women who fit in this category will receive medication for lowering insulin resistance and/or a weight loss medication.

The registry classes the interventions as behavioral and drug.

Who Took Part

Enrollment: 200 planned participants were the target.

It was open to women only aged from 45 years up to 55 years.

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

Examples of who could join: In the late menopausal transition, defined as 60 days of amenorrhea but less than 365 days of amenorrhea18. No current use of hormone therapy or hormonal contraception. Presence of a uterus and at least one ovary in order to track menstrual patterns. Have a smartphone and broadband access adequate to accept telehealth appointments.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: lack of broadband access (activity and survey data will be collected electronically whenever possible and some visits will be via telehealth); lack of regular menstrual periods in mid-reproductive life (ages 25-38) when not on hormones or not pregnant; pregnancy or actively trying to get pregnant.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2026-03-01 with completion listed for 2029-10-31.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Epigenetic aging measurements of "PhenoAge" (time frame: Up to 2 years). Epigenetic aging measurements of "GrimAge" (time frame: Up to 2 years).

It also tracked 8 secondary outcomes, for example IL-1, TNF-alpha, IL-6, IL-8, Flow-mediated dilation and Serum Marker for Ovarian Aging.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, non-randomized trial of Semaglutide in 200 people.

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

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