Actively Recruiting
GLP-1R Actions on Muscle and the Skeleton
Led by Pennington Biomedical Research Center · Updated on 2026-04-16
50
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
Sponsors
P
Pennington Biomedical Research Center
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GLP-1R Actions on Muscle and the Skeleton
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a body mass index (BMI) between 30 and 40 kg/m2 (inclusive)
- Be between 18 and 50 years of age (inclusive)
- Be a non-Hispanic Black male or female enrolled at PBRC
- Be a rural male or female enrolled at MaineHealth
- Female subjects must be premenopausal
- Female subjects must have had their last menstrual period less than 60 days before screening
- Female subjects must have no menopausal-associated vasomotor symptoms
- All subjects must be able to use the Lifestyle Toolkit as prescribed for the intervention group
You will not qualify if you...
- Males and females over 50 years of age
- Menopausal female subjects
- Use of systemic corticosteroids or other medications known to cause muscle and bone loss
- Use of medications that affect weight status
- Contraindications to tirzepatide as per package insert
- History of malignancy except non-melanoma skin cancer
- Known osteoporosis or current use of osteoporosis treatments
- Uncontrolled thyroid or parathyroid disease
- Clinically significant blood, kidney, liver disease, or diabetes
- Females of childbearing potential not agreeing to effective contraception during the study
- Inability to follow the Lifestyle Toolkit as prescribed
- Clinical depression with a PHQ-9 score of 15 or higher
- Unable to provide informed consent
- Under 18 years of age
- Pregnancy
- Incarceration
- Contraindications to MRI (e.g., metallic implants, claustrophobia, weight over 500 pounds)
- Vitamin D level below 15 ng/ml at baseline
- Significant EKG abnormalities posing risk for weight management therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
Research Team
R
Robert L Dubin, MD
CONTACT
S
Seaneen Hebert, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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