GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT06975111

RecruitingPhase 2, PHASE3

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

Lead sponsor

University of Colorado, Denver

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

200

estimated

Study population

Dyslipidemia, Hypertension, Obesity / overweight, Reproductive / infertility

Key I/E criterion

•Female

Primary endpoints

•Epigenetic aging measurements of "PhenoAge"•Epigenetic aging measurements of "GrimAge"

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06975111

Org study ID25-0943

Secondary IDU1111-1322-1036World Health Organization

Timeline

Milestones

Study first posted2025-05-16actual

Study start2026-03-01actual

Last update posted2026-04-30actual

Primary completion2029-10-31estimated

Study completion2030-10-01estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

DyslipidemiaHypertensionObesity / overweightReproductive / infertility

Eligibility

Who can enroll

Minimum age45 Years

Maximum age55 Years

SexFemale

Healthy volunteersAccepted

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.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Cardiometabolic biomarkers

Patient-reported / QoL

Other clinical outcomes

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint/low confidence

TNF-alpha

Time frame:Up to 2 years

change from baseline, improvement

Secondary/protocol endpoint

IL-6

Time frame:Up to 2 years

concentration, improvement

Secondary/protocol endpoint

Flow-mediated dilation

Time frame:Up to 2 years

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

MENQOL survey

Time frame:Up to 2 years

change from baseline, improvement

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Serum Marker for Ovarian Aging

Time frame:Up to 2 years

concentration, descriptive

Other (unclassified)

5 endpoints

Primary/protocol endpoint/low confidence

Epigenetic aging measurements of "PhenoAge"

Time frame:Up to 2 years

change from baseline, improvement

Primary/protocol endpoint/low confidence

Epigenetic aging measurements of "GrimAge"

Time frame:Up to 2 years

descriptive

Secondary/protocol endpoint/low confidence

IL-1

Time frame:Up to 2 years

concentration, descriptive

Secondary/protocol endpoint/low confidence

IL-8

Time frame:Up to 2 years

concentration, improvement

Secondary/protocol endpoint/low confidence

Eaotoxin levels

Time frame:Up to 2 years

descriptive

Publications (25)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Vasomotor Symptom Trajectories and Risk of Incident Diabetes.
JAMA network open2024 Oct 1PMID39480425doi:10.1001/jamanetworkopen.2024.43546via CT.gov background
A high-fat eucaloric diet induces reprometabolic syndrome of obesity in normal weight women.
PNAS nexus2024 Jan (month)PMID38178979doi:10.1093/pnasnexus/pgad440via CT.gov background
The Effectiveness of Metformin in Diabetes Prevention: A Systematic Review and Meta-Analysis.
Cureus2023 Sep (month)PMID37900422doi:10.7759/cureus.46108via CT.gov background
The 2022 hormone therapy position statement of The North American Menopause Society.
Menopause (New York, N.Y.)2022 Jul 1PMID35797481doi:10.1097/GME.0000000000002028via CT.gov background
Effects of preconception lifestyle intervention in infertile women with obesity: The FIT-PLESE randomized controlled trial.
PLoS medicine2022 Jan (month)PMID35041662doi:10.1371/journal.pmed.1003883via CT.gov background
Epigenetic age prediction.
Aging cell2021 Sep (month)PMID34415665doi:10.1111/acel.13452via CT.gov background
Abdominal visceral adipose tissue over the menopause transition and carotid atherosclerosis: the SWAN heart study.
Menopause (New York, N.Y.)2021 Mar 1PMID33651741doi:10.1097/GME.0000000000001755via CT.gov background
Menopausal Vasomotor Symptoms and Risk of Incident Cardiovascular Disease Events in SWAN.
Journal of the American Heart Association2021 Feb 2PMID33470142doi:10.1161/JAHA.120.017416via CT.gov background
A randomised trial examining inflammatory signaling in acutely induced hyperinsulinemia and hyperlipidemia in normal weight women-the reprometabolic syndrome.
PloS one2021 (year)PMID33764994doi:10.1371/journal.pone.0247638via CT.gov background
Hormones and bone loss across the menopause transition.
Vitamins and hormones2021 (year)PMID33706956doi:10.1016/bs.vh.2020.12.016via CT.gov background
Decline in endothelial function across the menopause transition in healthy women is related to decreased estradiol and increased oxidative stress.
GeroScience2020 Dec (month)PMID32770384doi:10.1007/s11357-020-00236-7via CT.gov background
Plasma proteomic biomarker signature of age predicts health and life span.
eLife2020 Nov 19PMID33210602doi:10.7554/eLife.61073via CT.gov background
Summary of Updated Recommendations for Primary Prevention of Cardiovascular Disease in Women: JACC State-of-the-Art Review.
Journal of the American College of Cardiology2020 May 26PMID32439010doi:10.1016/j.jacc.2020.03.060via CT.gov background
Vasomotor Symptoms and Accelerated Epigenetic Aging in the Women's Health Initiative (WHI).
The Journal of clinical endocrinology and metabolism2020 Apr 1PMID32080740doi:10.1210/clinem/dgaa081via CT.gov background
Reversal of epigenetic aging and immunosenescent trends in humans.
Aging cell2019 Dec (month)PMID31496122doi:10.1111/acel.13028via CT.gov background
The menopause transition and women's health at midlife: a progress report from the Study of Women's Health Across the Nation (SWAN).
Menopause (New York, N.Y.)2019 Oct (month)PMID31568098doi:10.1097/GME.0000000000001424via CT.gov background
Depression During and After the Perimenopause: Impact of Hormones, Genetics, and Environmental Determinants of Disease.
Obstetrics and gynecology clinics of North America2018 Dec (month)PMID30401549doi:10.1016/j.ogc.2018.07.007via CT.gov background
METFORMIN-SUSTAINED WEIGHT LOSS AND REDUCED ANDROID FAT TISSUE AT 12 MONTHS IN EMPOWIR (ENHANCE THE METABOLIC PROFILE OF WOMEN WITH INSULIN RESISTANCE): A DOUBLE BLIND, PLACEBO-CONTROLLED, RANDOMIZED TRIAL OF NORMOGLYCEMIC WOMEN WITH MIDLIFE WEIGHT GAIN.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2016 May (month)PMID26789348doi:10.4158/EP151087.ORvia CT.gov background
A Randomized Trial of Intensive versus Standard Blood-Pressure Control.
The New England journal of medicine2015 Nov 26PMID26551272doi:10.1056/NEJMoa1511939via CT.gov background
Carbohydrate modified diet & insulin sensitizers reduce body weight & modulate metabolic syndrome measures in EMPOWIR (enhance the metabolic profile of women with insulin resistance): a randomized trial of normoglycemic women with midlife weight gain.
PloS one2014 (year)PMID25259787doi:10.1371/journal.pone.0108264via CT.gov background
Progression rates of carotid intima-media thickness and adventitial diameter during the menopausal transition.
Menopause (New York, N.Y.)2013 Jan (month)PMID22990755doi:10.1097/gme.0b013e3182611787via CT.gov background
Are changes in cardiovascular disease risk factors in midlife women due to chronological aging or to the menopausal transition?
Journal of the American College of Cardiology2009 Dec 15PMID20082925doi:10.1016/j.jacc.2009.10.009via CT.gov background
Effects of the menopause transition and hormone use on cognitive performance in midlife women.
Neurology2009 May 26PMID19470968doi:10.1212/WNL.0b013e3181a71193via CT.gov background
Menopause and the metabolic syndrome: the Study of Women's Health Across the Nation.
Archives of internal medicine2008 Jul 28PMID18663170doi:10.1001/archinte.168.14.1568via CT.gov background
Validating the SF-36 health survey questionnaire: new outcome measure for primary care.
BMJ (Clinical research ed.)1992 Jul 18PMID1285753doi:10.1136/bmj.305.6846.160via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.