GLP-1R Actions on Muscle and the Skeleton (GRAMS Study)

This study, called GRAMS, is looking at how a GLP-1 based treatment for obesity, Tirzepatide, affects your muscles and bones. Researchers want to understand if weight loss from this medication, combined with a lifestyle program (daily protein shakes and resistance exercise three times a week), impacts your body composition. You might be eligible if you are between 18 and 50 years old, have a BMI between 30 and 40, and are a premenopausal female or a non-Hispanic Black male/female, or a rural male/female. The main goal is to measure changes in your fat-free mass (everything in your body that isn't fat, like muscle and bone) using DXA scans at the start, 3 months, and 6 months.

Study design: This is an interventional study with a planned enrollment of 50 participants. It includes a control group with regular exercise and diet.
What's involved: You would receive Tirzepatide or participate in a lifestyle program. Your fat-free mass will be measured at baseline, 3 months, and 6 months.
Compensation: Not stated in the trial record.
Follow-up: Your fat-free mass will be measured up to 6 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

GLP-1R Actions on Muscle and the Skeleton

Recruiting

PHASE4Ages 18–50InterventionalTreatment

Pennington Biomedical Research Center

~50 participants

Updated 2026-08-27 on ClinicalTrials.gov

What's tested:TirzepatideLifestyle toolkit

At a glance

Recruiting sites

1 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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.

Measured over Baseline and time 3, and 6 months.

Conditions

Musculoskeletal Abnormalities

Obesity

Sarcopenic Obesity

Osteoporosis

Drug Effect

Where it's being run

2 sites across 2 states

Louisiana1

Maine1

Who to contact

Adithya Hari, MD

[email protected]

225-763-2966

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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).

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.

What this trial measures

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.Baseline and time 3, and 6 months.
DXA (Dual energy Xray absorptiometry)

Trialytics