NCT07428746 Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes
| NCT ID | NCT07428746 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Emory University |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-05-07 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 20 participants in total. It began in 2026-05-07 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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 \>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 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 * 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
Contact & Investigator
Thaer Idrees, MD, FSSCI
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT07428746 clinical trial?
This trial is open to female participants only, aged 65 Years or older, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07428746 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 20 participants.
Is NCT07428746 currently recruiting?
Yes, NCT07428746 is actively recruiting participants. Contact the research team at thaer.idrees@emory.edu for enrollment information.
Where is the NCT07428746 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT07428746 clinical trial?
NCT07428746 is sponsored by Emory University. The principal investigator is Thaer Idrees, MD, FSSCI at Emory University. The trial plans to enroll 20 participants.
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