GLP-1R Actions on Muscle and the Skeleton
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-50
SponsorPennington Biomedical Research Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Tirzepatide
- Lifestyle toolkit
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Pennington Biomedical Research Center
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov