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

Recruiting now · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

The goal of this study is to learn how GLP-1 receptor agonist therapy affects muscle and bone health in older females over age 65 with type 2 diabetes. The main question it aims to answer is whether or not 6 months of GLP-1 RA therapy affects muscle strength. Participants will: * Receive GLP-1 RA therapy as part of their routine clinical care * Complete muscle strength assessments (hand grip strength, Timed Up and Go test) * Provide blood samples for bone turnover markers * Undergo bone mineral density testing

Key facts

Study ID

NCT07428746

Run by

Emory University

People needed

20

Starts

2026-05-07

Expected to finish

2028-11-01

Last updated by the study team

2026-08-03

Who can join

Age: 65 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 >7% 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

You may not qualify if…

• 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
• 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

Where it is running

• Grady Memorial Hospital — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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