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HomeTrials › NCT07428746

Type 2 diabetes · Phase 3 · Opening soon

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

NCT07428746 · Sponsor: Emory University

What this trial means for you

This study is opening soon at 1 US site. It's studying Semaglutide for diabetes mellitus, type 2.

Who can joinWomen, 65 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeSemaglutide
Study length~2.6 years overall
Planned participants20
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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

Study sites by state

Georgia

  • Grady Memorial Hospital — Atlanta

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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