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Trial · Interventional

RecruitingPhase 4Registry data

GLP-1R Actions on Muscle and the Skeleton

Short name GRAMS

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
50 participants (estimated)
Sponsor
Pennington Biomedical Research Center · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
9 Oct 2025
Primary completion
1 Feb 2027 (estimated)
Completion
1 May 2027 (estimated)
First posted
4 Sept 2025
Last update posted
27 Aug 2026
Conditions
Musculoskeletal Abnormalities · Obesity · Sarcopenic Obesity · Osteoporosis · Drug Effect

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2025202620272028
  1. Ph 4

    GRAMS

    NCT07154719

    9 Oct 2025 to est. 1 May 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug
  • Lifestyle toolkitBehavioral

Arms2

  • Experimental

    Treatment/intervention group

    Treatment with Tirzepatide for 5 months and lifestyle toolkit.

  • Placebo comparator

    Control/Placebo

    Treatment with Tirzepatide for 5 months with regular diet and exercise.

Primary outcomes1

Outcomes the sponsor listed as primary.

  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.

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

    Registry description

    DXA (Dual energy Xray absorptiometry)

Secondary outcomes(6)
  1. MRI (thigh) without contrast

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

    Registry description

    To assess for muscle quality (% of skeletal muscle to intermuscular fat)

  2. Osteocalcin

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

    Registry description

    Blood draw, metabolism biomarker

  3. Irisin

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

    Registry description

    Blood draw, bone health biomarker

  4. Procollagen 1 N-terminal peptide (P1NP)

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

    Registry description

    Blood draw, bone health biomarker

  5. C-Terminal Telopeptide of type I collagen (CTX-1)

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

    Registry description

    Blood draw, bone health biomarker

  6. Insulin-like Growth Factor 1 (IGF-1)

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

    Registry description

    Blood draw, bone health biomarker

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2022

6 results

Tirzepatide Once Weekly for the Treatment of Obesity.

Jastreboff et al. 2022The New England journal of medicinecited by 2,802

PMID 35658024DOI 10.1056/nejmoa2206038PUB-35658024

Full text at the publisher6 results

Indexing hint: Randomized controlled trial · 2021

14 results

Healthy Weight Loss Maintenance with Exercise, Liraglutide, or Both Combined.

Lundgren et al. 2021The New England journal of medicinecited by 417

PMID 33951361DOI 10.1056/nejmoa2028198PUB-33951361

Full text at the publisher14 results

More studies

1 study on this page

Indexing hint: Review · 2024

Glucagon-like peptide-1 receptor agonist-based agents and weight loss composition: Filling the gaps.

Dubin et al. 2024Diabetes, obesity & metabolismcited by 36

PMID 39344838DOI 10.1111/dom.15913PUB-39344838

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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