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HomeTrials › NCT07154719

Obesity & weight · Phase 4 · Recruiting now

GLP-1R Actions on Muscle and the Skeleton

NCT07154719 · Sponsor: Pennington Biomedical Research Center

What this trial means for you

This study is recruiting now at 1 US site. It's studying Tirzepatide for musculoskeletal abnormalities, obesity, sarcopenic obesity.

Who can joinAll sexes, 18 Years – 50 Years
Healthy volunteersNo — diagnosis required
What you'd takeTirzepatide
Study length~16 months overall
Planned participants50
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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.

Study sites by state

Louisiana

  • Pennington Biomedical Research Center — Baton Rouge · Recruiting now

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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