GLP-1R Actions on Muscle and the Skeleton (NCT07154719) | Clinical Trial Compass
Active — Not RecruitingPhase 4
GLP-1R Actions on Muscle and the Skeleton
United States50 participantsStarted 2025-10-09
Plain-language summary
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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects 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 subjects 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 subjects must be able to use Lifestyle Toolkit as prescribed for intervention arm.
Exclusion Criteria:
\- Males and females over the age of 50 years of age
* Menopausal females.
* Subjects on systemic corticosteroids or other agents known to increase loss of muscle and bone mass.
* Subjects who are on medications that increase or decrease weight status.
* Subjects having contraindications to tirzepatide in the package insert.
* Subjects with a history of malignancy other than non-melanoma skin cancer
* Subjects with known osteoporosis or are on osteoporosis therapies (gonadal hormones or hormone antagonists).
* Subjects with uncontrolled thyroid or parathyroid disease that may influence the study results.
* Subjects 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in fat free mass (FFM) using DXA imaging. FFM equals all body composition that is not fat mass. This includes bone, skeletal muscle, organs, water and all connective tissues. The unit of measurement is in kilograms (kg) at baseline, 3 and 6 mo.