Recruiting
Phase 3

GLP-1 RA

Sponsor:

Emory University

Code:

NCT07428746

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: Female

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Semaglutide

Study Details

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

Study ID

NCT07428746

Start date

May 7, 2026

Status verified date

Jul, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Type 2 Diabetics on Semaglutide

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.

Interventions

Semaglutide

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.

Primary outcome measure

  • Change in handgrip strength [ Time Frame: Baseline, week4, week 8, week12, week 26. ]

Central Contacts and Locations

Central contacts

Thaer Idrees, MD, FSSCI

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

Jaafer Zaino

jaafer.zaino@emory.edu

Locations

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Thaer Idrees, MD, FSSCI

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

Principal Investigator:

Thayer Idrees, MD

More Information

Sponsor

Emory University

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-08-03.