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GRAMS

RecruitingPhase 4

GLP-1R Actions on Muscle and the Skeleton

Lead sponsor

Pennington Biomedical Research Center

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Lean mass

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07154719

Org study IDPBRC 2024-031

Timeline

Milestones

Study first posted2025-09-04actual

Study start2025-10-09actual

Last update posted2026-05-29actual

Primary completion2027-02-01estimated

Study completion2027-05-01estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age50 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Weight & body composition

2 endpoints

Primary/protocol endpoint

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.

Time frame:Baseline and time 3, and 6 months.

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

MRI (thigh) without contrast

Time frame:Month 1 (baseline), month 3, month 6 (final visit)

descriptive