GLP-1 Receptor Agonist-Induced Loss and Impairment of Muscle Mass - Evaluation of Response
Semaglutide's Effect on Heart and Muscle Mass Studied
Plain English Summary
Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass is a Not Applicable clinical trial sponsored by University of Alberta studying Type 2 Diabetes, Obesity, Semaglutide. This study investigates how semaglutide (Ozempic/Wegovy) affects muscle and heart mass over 12 months. It is for adults with Type 2 Diabetes or obesity who are starting semaglutide treatment. Participation involves MRI scans, physical tests, questionnaires, and blood/food samples. Alternatives include standard medical care and lifestyle changes for diabetes and weight management. The trial aims to enroll 50 participants.
Official Summary
The aim of this study is to use advanced MRI scans to track changes in both muscle and fat in the body and heart over a 12-month period in individuals starting semaglutide. By doing so, we hope to gain a clearer understanding of how semaglutide affects muscle health and function. Our goal is to ensure the medication supports long-term well-being, particularly for people who may be at higher risk of muscle loss. This study involves (3) in-person study visits. At each visit, participants will be asked to: * Undergo magnetic resonance imaging (MRI) while resting and during exercise to take pictures of their heart, abdomen, and legs. * Complete tests to assess balance, sit-to-stand, walking speed, and handgrip strength. * Complete questionnaires related to demographics, health information, physical activity, and nutrition. * Have a blood sample collected. * Have blood levels assessed through two finger pricks. * Complete three days of food records.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18-75 can join if they are starting semaglutide for Type 2 Diabetes or weight loss (BMI ≥27.5). You cannot join if you have used semaglutide for over 2 weeks, have recent major heart problems, or have health concerns that prevent MRI scans (like metal implants or severe claustrophobia). This trial is studying Type 2 Diabetes, Obesity, Semaglutide, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how skeletal and cardiac muscle mass change over 12 months, meaning it will show if semaglutide affects the size of your muscles and heart. The specific primary outcome measures are: Changes in skeletal and cardiac muscle mass (12 months). 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 study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important for understanding how semaglutide, a popular medication for diabetes and weight loss, impacts muscle health, addressing a potential gap in knowledge about long-term well-being. This research targets Type 2 Diabetes, Obesity, Semaglutide, where improved treatment options are needed.
Investor Insight
This observational study on a widely used drug like semaglutide signals continued interest in its comprehensive effects, potentially influencing future treatment guidelines and market positioning.
Is This Trial Right for Me?
Ask your doctor about the potential effects of semaglutide on muscle mass and if this study is right for you. You will have 3 in-person visits over 12 months, each involving MRI scans, physical tests, questionnaires, and sample collection. The trial is being conducted at multiple sites. 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: OBSERVATIONAL
- Enrollment: 50 participants
Primary Outcomes
- Changes in skeletal and cardiac muscle mass (12 months)
Full Eligibility Criteria
Inclusion Criteria: * Adults 18-75 years of age * Starting semaglutide for type 2 diabetes or weight loss (body mass index ≥27.5kg/m2) * Able to safely undergo an MRI scan (including meeting the physical requirements for MRI equipment) Exclusion Criteria: * Current use of semaglutide for more than 2 weeks * Major recent heart issues or other severe health conditions * Concerns related to MRI use (including metal implants, pacemaker, severe claustrophobia)
Frequently Asked Questions
What is clinical trial NCT07272837?
NCT07272837 is a Not Applicable OBSERVATIONAL study titled "Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass." It is currently not yet recruiting and is sponsored by University of Alberta. The trial targets enrollment of 50 participants.
What conditions does NCT07272837 study?
This trial investigates treatments for Type 2 Diabetes, Obesity, Semaglutide. The primary condition under study is Type 2 Diabetes.
What does Not Applicable mean for NCT07272837?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07272837?
This trial is currently "Not Yet Recruiting." It started on 2026-04-01. The estimated completion date is 2028-04-30.
Who is sponsoring NCT07272837?
NCT07272837 is sponsored by University of Alberta. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07272837?
The trial aims to enroll 50 participants. The trial has not yet started recruiting.
How is NCT07272837 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07272837?
The primary outcome measures are: Changes in skeletal and cardiac muscle mass (12 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07272837?
The official record for NCT07272837 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07272837. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07272837 testing in simple terms?
This study investigates how semaglutide (Ozempic/Wegovy) affects muscle and heart mass over 12 months. It is for adults with Type 2 Diabetes or obesity who are starting semaglutide treatment.
Why is this trial significant?
This trial is important for understanding how semaglutide, a popular medication for diabetes and weight loss, impacts muscle health, addressing a potential gap in knowledge about long-term well-being.
What are the potential risks of participating in NCT07272837?
Potential risks include discomfort during MRI scans or minor pain from blood draws. Side effects of semaglutide itself, such as nausea or digestive issues, may occur. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07272837?
Ask your doctor about the potential effects of semaglutide on muscle mass and if this study is right for you. You will have 3 in-person visits over 12 months, each involving MRI scans, physical tests, questionnaires, and sample collection. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07272837 signal from an investment perspective?
This observational study on a widely used drug like semaglutide signals continued interest in its comprehensive effects, potentially influencing future treatment guidelines and market positioning. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves MRI scans, physical tests, questionnaires, and blood/food samples. 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
More Type 2 Diabetes Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.