NCT07428746RecruitingPhase 3
Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 17 Feb 2026
- Start date
- 7 May 2026
- Primary completion date
- Nov 2028
- Lead sponsor
- Emory University
- Diseases
- Type 2 diabetes
- NCT number
- NCT07428746
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 20
- From 7 May 2026 to the primary completion date, Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Previous fragility fracture
- 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
Other illness
- Patients with type 1 diabetes mellitus or other types of diabetes that are not T2D
- Moderate to severe gastroesophageal reflux disease based on patient history.
- 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.
Lab values
- eGFR \<30 ml/min in the last 3 months
- Aspartate aminotransferase (AST) \> 3 times normal or alanine aminotransferase (ALT) \> 3 times the normal
Other
- Documented presence of prosthesis or devices in the spine or hip
- Males
- Inability to comply with the treatment protocol or to understand the consent form.
- Incarcerated individuals
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Grady Memorial Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.