Current partner codePEPTIDESDE
PeptideStat
Menu

Vendors

Compare pricesVendor directoryVendor reviewsDiscount codesLab tests & COAs

Research

ResearchDatabaseClinical trials

Tools

All calculatorsReconstitutionAccumulationUnit converterPeptide chemistry
NCT06975111·Phase 2 / Phase 3·INTERVENTIONAL

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

SemaglutideOtherRecruiting

Status

Recruiting

Phase

Phase 2 / Phase 3

Enrollment

200

Locations

3

Results

Not posted

Publications

12

Study summary

What the protocol is testing.

What if midlife women, who are inherently at an increased risk for future cardiometabolic disease due to transitioning into menopause, had access to a suite of evidence-based health interventions? Could these interventions reduce menopause-related inflammation, restore a healthier cardiometabolic profile, reverse epigenetic aging, and reduce bothersome menopausal symptoms? The ultimate goal of this work is to attenuate future disease and enhance women's quality of life, extend healthspan and increase productivity.

Interventions

Treatment arms and agents.

DRUG

Metformin

Metformin will be given to participants who have a elevated HbA1c and also for weightloss.

DRUG

semaglutide

Overweight women and women with obesity will take Semaglutide for weight-loss

DRUG

Anti-hypertensives

a. Antihypertensives, with the goal of maintaining blood pressure at 130/80 or lower per ACC guidelines19. Per current clinical guidelines and standard of care, hypertension will be treated first with monotherapy using either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), a calcium channel blocker, or a thiazide diuretic provided that are no contraindications.

DRUG

Lipid Lowering Medication

. First line agents will be generic statin medications (atorvastatin or rosuvastatin)whichever is covered by the participant's health insurance), barring contraindication to their use.

BEHAVIORAL

Life style intervention

will simply be followed and given preventive advice (maintenance of a normal BMI and physical activity, moderation in salt intake, and no more than 1 alcoholic drink per day). They will be provided with a wearable activity monitor. This advice will be based on guidelines by the American Heart Association and the Menopause Society.

DRUG

Fezolinetant

Women with menopausal symptoms will be treated with hormone therapy (estrogen and progesterone) if appropriate, or with a neurokinin receptor antagonist (Fezolinetant). This can be treatment for women in any arm of the study as well as an arm by its self.

DRUG

Hormonal therapy

Participants will be treated with estrogen and/or progesterone for treatment of hot flashes in women during the study.

Timeline

From registration to results.

  1. First posted

    May 16, 2025

  2. Study start

    Mar 1, 2026

  3. Primary completion

    Oct 31, 2029

  4. Study completion

    Oct 1, 2030

  5. Results posted

    Not reported

  6. Registry updated

    Jul 21, 2026

Outcomes

What the study measures.

Primary outcomes

Epigenetic aging measurements of "PhenoAge"

Time frame · Up to 2 years

Change in epigenetic aging, as assessed by PhenoAge. PhenoAge calculates a biological age score based on key biomarkers circulating in the bloodstream. A lower PhenoAge score suggests slower biological aging, while a higher score indicates accelerated aging.

Epigenetic aging measurements of "GrimAge"

Time frame · Up to 2 years

Epigenetic aging, as assessed by GrimAge. GrimAge assesses lifespan from examining DNA Methylation.

Secondary outcomes

IL-1

Time frame · Up to 2 years

Inflammatory IL-1 serum levels, examined to determine a person's inflammatory state. Higher levels of IL-1 can indicate more inflammation. Being in an "inflamed state" can have detrimental effects on a woman's health.

TNF-alpha

Time frame · Up to 2 years

Serum inflammatory marker TNF-alpha. Higher levels of TNF-alpha can indicate more inflammation. TNF-alpha is examined to determine a person's inflammatory state.

IL-6

Time frame · Up to 2 years

Serum IL-6 levels. IL-6 is examined to determine a person's inflammatory state. Higher levels of IL-6 indicate more inflammation. Being in an "inflamed state" can have detrimental effects on a women's health.

IL-8

Time frame · Up to 2 years

IL-8 serum levels. IL-8 is examined to determine a person's inflammatory state. Higher levelf of IL-8 indicate more inflammation. Being in an "inflamed state" can have detrimental effects on a women's health.

Flow-mediated dilation

Time frame · Up to 2 years

Flow-mediated dilation measures the diameter of vascular and endothelial cell function and predicts cardiovascular event risk. The diameter of the target artery is measured by high-resolution external vascular ultrasound in response to an increase in blood flow.

Serum Marker for Ovarian Aging

Time frame · Up to 2 years

Anti-mullerian hormones (AMH) serum levels will be analyzed. AMH is an indicator of ovarian aging and reflects egg supply. Lower levels of AMH indicate a lower egg supply.

MENQOL survey

Time frame · Up to 2 years

Menopause-specific Quality of Life (MENQOL) measures quality of life in menopausal women. It is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor, psychosocial, physical, and sexual. There will be a overall score and we are examining if there is a change in response to treatment.

Eaotoxin levels

Time frame · Up to 2 years

Eaotoxin is a inflammatory marker that increases when there is an inflammed state in a woman. Serum Eaotoxin will be measured before, during and at the end of the study.

Eligibility

Who can take part.

Minimum age
45 Years
Maximum age
55 Years
Sex
FEMALE
Healthy volunteers
Yes

Inclusion Criteria: * aged 45-55 * 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 Exclusion Criteria: * 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 * Inability to adhere to study protocol schedule * Untreated alcoholism * Un- Diagnosed abnormal uterine bleeding * Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (MEN 2) for participants with a BMI\> 30 kg/m2.

Study locations

3 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

University of Colorado-School of Medicine

Aurora, Colorado, United States

University of North Carolina, School of Medicine

Chapel Hill, North Carolina, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Publications

Results and literature.

PMID 1285753 ↗Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.PMID 26551272 ↗SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9.PMID 19470968 ↗Greendale GA, Huang MH, Wight RG, Seeman T, Luetters C, Avis NE, Johnston J, Karlamangla AS. Effects of the menopause transition and hormone use on cognitive performance in midlife women. Neurology. 2009 May 26;72(21):1850-7. doi: 10.1212/WNL.0b013e3181a71193.PMID 20082925 ↗Matthews KA, Crawford SL, Chae CU, Everson-Rose SA, Sowers MF, Sternfeld B, Sutton-Tyrrell K. Are changes in cardiovascular disease risk factors in midlife women due to chronological aging or to the menopausal transition? J Am Coll Cardiol. 2009 Dec 15;54(25):2366-73. doi: 10.1016/j.jacc.2009.10.009.PMID 33651741 ↗Samargandy S, Matthews KA, Brooks MM, Barinas-Mitchell E, Magnani JW, Janssen I, Kazlauskaite R, El Khoudary SR. Abdominal visceral adipose tissue over the menopause transition and carotid atherosclerosis: the SWAN heart study. Menopause. 2021 Mar 1;28(6):626-633. doi: 10.1097/GME.0000000000001755.PMID 33210602 ↗Tanaka T, Basisty N, Fantoni G, Candia J, Moore AZ, Biancotto A, Schilling B, Bandinelli S, Ferrucci L. Plasma proteomic biomarker signature of age predicts health and life span. Elife. 2020 Nov 19;9:e61073. doi: 10.7554/eLife.61073.PMID 32080740 ↗Thurston RC, Carroll JE, Levine M, Chang Y, Crandall C, Manson JE, Pal L, Hou L, Shadyab AH, Horvath S. Vasomotor Symptoms and Accelerated Epigenetic Aging in the Women's Health Initiative (WHI). J Clin Endocrinol Metab. 2020 Apr 1;105(4):1221-7. doi: 10.1210/clinem/dgaa081.PMID 31496122 ↗Fahy GM, Brooke RT, Watson JP, Good Z, Vasanawala SS, Maecker H, Leipold MD, Lin DTS, Kobor MS, Horvath S. Reversal of epigenetic aging and immunosenescent trends in humans. Aging Cell. 2019 Dec;18(6):e13028. doi: 10.1111/acel.13028. Epub 2019 Sep 8.PMID 33470142 ↗Thurston RC, Aslanidou Vlachos HE, Derby CA, Jackson EA, Brooks MM, Matthews KA, Harlow S, Joffe H, El Khoudary SR. Menopausal Vasomotor Symptoms and Risk of Incident Cardiovascular Disease Events in SWAN. J Am Heart Assoc. 2021 Feb 2;10(3):e017416. doi: 10.1161/JAHA.120.017416. Epub 2021 Jan 20.PMID 39480425 ↗Hedderson MM, Liu EF, Lee C, El Khoudary SR, Gold EB, Derby CA, Thurston RC. Vasomotor Symptom Trajectories and Risk of Incident Diabetes. JAMA Netw Open. 2024 Oct 1;7(10):e2443546. doi: 10.1001/jamanetworkopen.2024.43546.PMID 32439010 ↗Cho L, Davis M, Elgendy I, Epps K, Lindley KJ, Mehta PK, Michos ED, Minissian M, Pepine C, Vaccarino V, Volgman AS; ACC CVD Womens Committee Members. Summary of Updated Recommendations for Primary Prevention of Cardiovascular Disease in Women: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 May 26;75(20):2602-2618. doi: 10.1016/j.jacc.2020.03.060.PMID 37900422 ↗Patel D, Ayesha IE, Monson NR, Klair N, Patel U, Saxena A, Hamid P. The Effectiveness of Metformin in Diabetes Prevention: A Systematic Review and Meta-Analysis. Cureus. 2023 Sep 28;15(9):e46108. doi: 10.7759/cureus.46108. eCollection 2023 Sep.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Semaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsSemaglutide trial dashboard →DatabaseSemaglutide database entry →ResearchSemaglutide research guide →