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New treatment option for Musculoskeletal Abnormalities
Official title GLP-1R Actions on Muscle and the Skeleton
ClinicalTrials.gov ID: NCT07154719
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, being studied as a potential treatment for musculoskeletal abnormalities.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The GRAMS study objectives are to assess the musculoskeletal changes that occur after weight loss using GLP-1 based therapy. A lifestyle intervention with diet and exercise is included to assess any mitigating effects are provided, versus a control group with regular exercise and diet.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- people will have a BMI between 30kg/m2
- 40kg/m2 (inclusive)
- Be between 18 and 50 years of age (inclusive).
- Non-Hispanic Black males and females will be enrolled at PBRC.
- Rural males and females will be enrolled at MaineHealth.
You likely can't join if
- \- Males and females over the age of 50 years of age
- Menopausal females.
- people on systemic corticosteroids or other agents known to increase loss of muscle and bone mass.
- people who are on medications that increase or decrease weight status.
- people having contraindications to tirzepatide in the package insert.
- people with a history of malignancy other than non-melanoma skin cancer
See the full eligibility criteria
- people will have a BMI between 30kg/m2
- 40kg/m2 (inclusive)
- Be between 18 and 50 years of age (inclusive).
- Non-Hispanic Black males and females will be enrolled at PBRC.
- Rural males and females will be enrolled at MaineHealth.
- Female people will be premenopausal.
- Females have had their last menstrual period less than 60 days before screening.
- Females have the absence of menopausal-associated vasomotor symptoms.
- All people must be able to use Lifestyle Toolkit as prescribed for intervention arm.
- \- Males and females over the age of 50 years of age
- Menopausal females.
- people on systemic corticosteroids or other agents known to increase loss of muscle and bone mass.
- people who are on medications that increase or decrease weight status.
- people having contraindications to tirzepatide in the package insert.
- people with a history of malignancy other than non-melanoma skin cancer
- people with known osteoporosis or are on osteoporosis therapies (gonadal hormones or hormone antagonists).
- people with uncontrolled thyroid or parathyroid disease that may influence the study results.
- people with a clinically significant hematologic abnormality, kidney disease, liver disease, or diabetes.
- Females of childbearing potential who do not agree to using an effective method of contraception during the study. Medically acceptable methods include oral contraceptive medication, an intrauterine device (IUD), an...
- Unable to follow Lifestyle Toolkit as prescribed for intervention arm.
- Patient Health Questionnaire-9 (PHQ-9) Score equal to or greater than 15 (clinical depression).
- Adults who are unable to consent.
- Individuals who are not yet adults (infants, children and teenagers).
- Pregnant females.
- Incarcerated individuals.
- Contraindication to MRI - including but not limited to non-removable metallic or electronic implants, claustrophobia or other fear of confinement, inability to tolerate loud scanner noise, body weight greater than 500...
- people with a baseline level of 25-OH vitamin D \<15 ng/ml will be excluded from the trial. The subject's physician will be notified, and the subject will be referred to their primary care physician.
- Any significant EKG abnormalities that are considered a risk for utilizing weight management therapies.
The study team makes the final eligibility decision.
Where it's taking place
- Baton Rouge, Louisiana, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baton Rouge, Louisiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.