Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes
Trial tests GLP-1 therapy for muscle/bone health in older women with diabetes
Plain English Summary
Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes is a Phase 3 clinical trial sponsored by Emory University studying Diabetes Mellitus, Type 2. This trial investigates how a common diabetes medication (GLP-1 RA therapy) affects muscle and bone strength in older women with type 2 diabetes. It is for postmenopausal women aged 65 and older who have type 2 diabetes and a BMI between 27-40. Participants will receive GLP-1 RA therapy as part of their regular care and undergo muscle strength tests, blood draws, and bone density scans. Alternatives include other diabetes medications, lifestyle changes, and specific treatments for bone and muscle loss. The trial aims to enroll 20 participants.
Official 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
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are a postmenopausal woman, 65 or older, have type 2 diabetes, and meet specific BMI and blood sugar (HbA1c) ranges. You cannot join if you have type 1 diabetes, severe kidney problems, osteoporosis, certain bone or spine conditions, or have recently used specific osteoporosis or weight loss medications. Participants must be able to follow study instructions, including fasting for some visits. Males and individuals with certain other medical conditions like gastroparesis or severe reflux are excluded. This trial is studying Diabetes Mellitus, Type 2, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how well participants can grip with their hands, indicating muscle strength, which is crucial for daily activities and overall independence. The specific primary outcome measures are: Change in handgrip strength (Baseline, week4, week 8, week12, week 26.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses a gap in understanding how diabetes medications can simultaneously benefit bone and muscle health, which often decline with age and diabetes. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Diabetes Mellitus, Type 2, where improved treatment options are needed.
Investor Insight
This trial signals potential for GLP-1 RAs to offer broader benefits beyond glucose control, potentially impacting a significant market of aging adults with diabetes and related bone/muscle issues. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if this GLP-1 RA therapy is appropriate for you and how it might interact with your current medications. Be prepared for regular clinic visits for assessments and blood draws. The therapy involves a weekly self-injection, and you'll need to follow fasting guidelines for certain tests. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 20 participants
Interventions
- DRUG: 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 Outcomes
- Change in handgrip strength (Baseline, week4, week 8, week12, week 26.)
Secondary Outcomes
- 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.)
Full 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 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 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 or DPP-4 inhibitors * 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
Trial Locations
- Grady Memorial Hospital, Atlanta, Georgia, United States
Frequently Asked Questions
What is clinical trial NCT07428746?
NCT07428746 is a Phase 3 INTERVENTIONAL study titled "Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes." It is currently not yet recruiting and is sponsored by Emory University. The trial targets enrollment of 20 participants.
What conditions does NCT07428746 study?
This trial investigates treatments for Diabetes Mellitus, Type 2. The primary condition under study is Diabetes Mellitus, Type 2.
What treatments are being tested in NCT07428746?
The interventions being studied include: 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.
What does Phase 3 mean for NCT07428746?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT07428746?
This trial is currently "Not Yet Recruiting." It started on 2026-04. The estimated completion date is 2028-11.
Who is sponsoring NCT07428746?
NCT07428746 is sponsored by Emory University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07428746?
The trial aims to enroll 20 participants. The trial has not yet started recruiting.
How is NCT07428746 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT07428746?
The primary outcome measures are: Change in handgrip strength (Baseline, week4, week 8, week12, week 26.). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07428746 being conducted?
This trial is being conducted at 1 site, including Atlanta, Georgia (United States).
Where can I find official information about NCT07428746?
The official record for NCT07428746 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07428746. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07428746 testing in simple terms?
This trial investigates how a common diabetes medication (GLP-1 RA therapy) affects muscle and bone strength in older women with type 2 diabetes. It is for postmenopausal women aged 65 and older who have type 2 diabetes and a BMI between 27-40.
Why is this trial significant?
This trial addresses a gap in understanding how diabetes medications can simultaneously benefit bone and muscle health, which often decline with age and diabetes. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT07428746?
Common side effects of GLP-1 RAs can include nausea, vomiting, diarrhea, and constipation. There is a small risk of more serious side effects like pancreatitis, gallbladder problems, or allergic reactions. Bone density may be affected, and muscle strength assessments will monitor for any decline. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07428746?
Ask your doctor if this GLP-1 RA therapy is appropriate for you and how it might interact with your current medications. Be prepared for regular clinic visits for assessments and blood draws. The therapy involves a weekly self-injection, and you'll need to follow fasting guidelines for certain tests. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07428746 signal from an investment perspective?
This trial signals potential for GLP-1 RAs to offer broader benefits beyond glucose control, potentially impacting a significant market of aging adults with diabetes and related bone/muscle issues. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participants will receive GLP-1 RA therapy as part of their regular care and undergo muscle strength tests, blood draws, and bone density scans. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.