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

NCT07428746 | Not Yet Recruiting Phase 3 FDA Drug

• 2 other identifiers: 2025P013673K12AR084234
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2

Keywords

GLP-1 Receptor analogs; Semaglutide; DEXA; Osteosarcopenia; Bone Mineral Density; Bone turnover markers

Outcome Measures

Primary Outcomes (1)

• Change in handgrip strength

  Handgrip strength is a validated indicator of overall muscle strength and a core diagnostic component of sarcopenia. HGS will be assessed using a calibrated hydraulic hand dynamometer. Output is recorded in kilograms (kg) of force. Higher values indicate greater muscle strength

  Baseline, week4, week 8, week12, week 26.

Secondary Outcomes (10)

• Change in bone turnover markers

  Baseline, 3 month, 6 months

• Change in timed up-and-go (TUG)

  Baseline, week4, week 8, week12, week 26.

• Change in HbA1c

  Baseline, 3 month, 6 months

• Change in fasting glucose

  Baseline, 6 months

• Change in weight

  Baseline, week4, week 8, week12, week 26.

Other Outcomes (1)

• Change in bone mineral density

  Baseline, 6 months

Study Arms (1)

Type 2 Diabetics on Semaglutide

EXPERIMENTAL

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.

Drug: Semaglutide

Interventions

Semaglutide DRUG

Semaglutide is an FDA-approved drug for the treatment of T2D at the following doses (0.25, 0.5, 1, and 2 mg) that is self-administered weekly using an autoinjector pen. The drug dosage will gradually increase every 4 weeks if tolerated to reach maintenance doses of 2 mg for semaglutide until the end of the study (6 months). If a participant cannot tolerate a dose, the highest tolerable dose will be administered, with continued efforts to increase the dose over time, gradually.

Also known as: GLP 1 RA

Type 2 Diabetics on Semaglutide

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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 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

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.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Thaer Idrees, MD, FSSCI

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thaer Idrees, MD, FSSCI

CONTACT

404-251-5357; thaer.idrees@emory.edu

Jaafer Zaino

CONTACT

jaafer.zaino@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)