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GLOW

Not yet recruitingPhase 3

Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes

Lead sponsor

Emory University

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•HbA1c 7-10%•Age ≥65•Female

Primary endpoint

•Handgrip strength

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 IDNCT07428746

Org study ID2025P013673

Secondary IDK12AR084234

Timeline

Milestones

Study first posted2026-02-24actual

Last update posted2026-02-24actual

Study start2026-04estimated (month precision)

Primary completion2028-11estimated (month precision)

Study completion2028-11estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age65 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•Postmenopausal women aged 65 years or older

•Has type 2 diabetes

•Body Mass Index (BMI) ≥27 kg/m² to max 40kg/m2 (inclusive)

•Hemoglobin A1c between 7-10% within 3 months of the first visit.

•Willingness and ability to comply with all study procedures, including fasting requirements for certain visits.

•No osteoporosis confirmed on DEXA scan within 12 months

•Able to provide informed consent and participate in all study assessments

Exclusion criteria

•Patients with type 1 diabetes mellitus or other types of diabetes that are not T2D

•eGFR <30 ml/min in the last 3 months

•Patients with a history of treatment with anti-osteoporosis agents

•Documented primary or secondary osteoporosis on a DEXA scan within the last 12 months, or are on osteoporosis therapies

•Documented presence of prosthesis or devices in the spine or hip

•Previous fragility fracture

•Males

•Moderate to severe gastroesophageal reflux disease based on patient history.

•Inability to comply with the treatment protocol or to understand the consent form.

•Aspartate aminotransferase (AST) > 3 times normal or alanine aminotransferase (ALT) > 3 times the normal

•Subjects with uncontrolled thyroid or parathyroid disease that may influence the study results.

•Personal or family history of medullary thyroid carcinoma.

•Personal or family history of multiple endocrine neoplasia type 2 syndrome.

•Personal history of gastroparesis, celiac disease, hypogonadism, severe COPD, hypopituitarism, or Cushing's disease

•Personal history of severe diabetic retinopathy.

•Known serious hypersensitivity, including anaphylaxis and angioedema, to semaglutide or any of its excipients.

•Any of the following drugs or treatments were used within 6 months before screening: treated with GLP-1RA, GIP analogues, pioglitazones or DPP-4 inhibitors

•Concomitant treatment with GLP-1 receptor agonist therapy

•Long-term intravenous, oral and intra-articular administration of high dose corticosteroids within 2 months before screening (more than 7 days in a row)

•Use of weight control drugs or surgery that can lead to weight changes during the last 6 months before screening, or are currently in the weight loss plan and are not in the maintenance stage

•Incarcerated individuals

Endpoints (12)

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 clinical outcomes

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

2 endpoints

Primary/protocol endpoint

Change in handgrip strength

Time frame:Baseline, week4, week 8, week12, week 26.

change from baseline, improvement

Secondary/protocol endpoint

Change in weight

Time frame:Baseline, week4, week 8, week12, week 26.

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in HbA1c

Time frame:Baseline, 3 month, 6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting glucose

Time frame:Baseline, 6 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change in lipid profile

Time frame:Baseline, 3 months, 6 months

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Changes in exercise duration

Time frame:Baseline, 6 months

change from baseline, improvement

Other clinical outcomes

6 endpoints

Secondary/protocol endpoint/low confidence

Change in bone turnover markers

Time frame:Baseline, 3 month, 6 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in timed up-and-go (TUG)

Time frame:Baseline, week4, week 8, week12, week 26.

change from baseline, improvement

Secondary/protocol endpoint

Change in FRAX score

Time frame:Baseline, 6 months

change from baseline, improvement

Secondary/protocol endpoint

Changes in exercise frequency

Time frame:Baseline, 6 months

change from baseline, improvement

Secondary/protocol endpoint

Change in frailty assessment

Time frame:Baseline, 6 months

change from baseline, improvement

Other/protocol endpoint

Change in bone mineral density

Time frame:Baseline, 6 months

change from baseline, improvement

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.