GLP-1R Actions on Muscle and the Skeleton

Q: What is the NCT07154719 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Q: Who can participate in NCT07154719?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07154719?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

GLP-1R Actions on Muscle and the Skeleton (NCT07154719) is a Phase 4 interventional studying Musculoskeletal Abnormalities and Obesity, sponsored by Pennington Biomedical Research Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 50 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Musculoskeletal Abnormalities subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: \- 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 (IUD), an implantable contraceptive (such as Implanon), or a barrier method (such as condom or diaphragm with spermicide). Injectable contraceptives such as Depo-Provera are a cause for exclusion in that they can cause bone loss. Abstinence is acceptable, as is sexual activity exclusively with same sex partners. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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 (IUD), an implantable contraceptive (such as Implanon), or a barrier method (such as condom or diaphragm with spermicide). Injectable contraceptives such as Depo-Provera are a cause for exclusion in that they can cause bone loss. Abstinence is acceptable, as is sexual activity exclusively with same sex partners. Fertility Appreciation Based Methods (natural family planning) are also acceptable forms of addressing childbearing potential in all subjects. A urine pregnancy test (UPT) will be performed on all females of childbearing potential at the screening visit, 3 and 6 months. * 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 pounds. * Subjects 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.

Treatments Being Tested

DRUG

Tirzepatide

GLP-1 based treatment for obesity

BEHAVIORAL

Lifestyle toolkit

2 ABBOTT protein shakes daily and resistance-based exercise x 3 days per week.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07154719), the sponsor (Pennington Biomedical Research Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07154719 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07154719?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07154719?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07154719. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07154719. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.