Semaglutide and muscle and bone health in older women with type 2 diabetes
Studies how semaglutide affects muscle and bone in older women with type 2 diabetes.
Key facts
- Who runs it
- Emory University
- Where
- Atlanta, United StatesSee the site
- Trial code
- Registry title
- Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 20 people, planned
- Started
- 7 May 2026
- Expected to end
- Nov 2028
- Type of study
- Interventional
- Treatments tested
- Semaglutide
- Record updated
- 3 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for postmenopausal women aged 65 or older with type 2 diabetes, who will start GLP-1 RA therapy as part of routine care, to study effects on muscle and bone.
- Age
- 65 years or older
- Sex
- Women only (postmenopausal)
- Disease stage
- Type 2 diabetes with hemoglobin A1c above 7% (53 mmol/mol) within 3 months of the first visit; BMI from 27 to 40 kg/m²; no osteoporosis on a DEXA scan within 12 months
- Earlier treatment
- No past treatment with anti-osteoporosis drugs. No GLP-1RA, GIP analogues or pioglitazones within 6 months before screening. No weight control drugs or surgery in the last 6 months.
Main reasons for not taking part
- Type 1 diabetes or other types of diabetes that are not type 2
- Osteoporosis on a DEXA scan, a previous fragility fracture, or a prosthesis or device in the spine or hip
- eGFR below 30 ml/min in the last 3 months
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 syndrome
- Serious allergy to semaglutide or its excipients
The registry criteria, word for word
Show all 28 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- eGFR <30 ml/min in the last 3 months
- Aspartate aminotransferase (AST) > 3 times normal or alanine aminotransferase (ALT) > 3 times the normal
- 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
Where in United States
- Grady Memorial HospitalAtlanta, United StatesContact: Thaer Idrees, MD, FSSCITaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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
The group in the trial
- Type 2 Diabetics on SemaglutideTreatment being tested
Participants will receive a GLP-1 receptor agonist (GLP-1 RA) prescribed as part of their routine clinical care. Dosing will follow standard clinical practice and will be titrated to each participant's maximum tolerated dose. The study will observe metabolic, musculoskeletal, and functional changes associated with ongoing GLP-1 RA therapy over a 6-month period.
Treatment: Semaglutide
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes
- Plain-language title
- Semaglutide and muscle and bone health in older women with type 2 diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 August 2026