Intramuscular lipid content is increased in obesity and decreased by weight loss.
B H Goodpaster, R Theriault, S C Watkins...
https://pubmed.ncbi.nlm.nih.gov/10778870Actively Recruiting
Phase 4
Age: 18Years - 50Years
All Genders
ID07154719
GLP-1R Actions on Muscle and the Skeleton: Effects of Tirzepatide and Lifestyle Interventions on Musculoskeletal Health in Adults with Obesity
Led by Pennington Biomedical Research Center · Updated on 2026-05-29
50
Participants Needed
1
Research Sites
12 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
Researchers are investigating the effects of GLP-1 based therapy on muscle and bone changes following weight loss, focusing on obesity and type 2 diabetes, especially in vulnerable groups like elderly and minority populations. The study aims to understand how weight loss through these therapies impacts the musculoskeletal system, including muscle mass and bone density, and explores if lifestyle changes like diet and resistance exercise can reduce any negative effects. The trial also addresses knowledge gaps around the combined GLP-1 and GIP treatment tirzepatide and its impact on muscle and bone, particularly in underserved populations. Participants will be randomly assigned to one of two groups: one receiving tirzepatide along with a lifestyle toolkit that includes protein shakes and resistance exercise, and the other receiving tirzepatide with regular diet and exercise. The treatment period lasts five months. Researchers will evaluate changes in fat-free mass, muscle quality, and bone markers, using imaging techniques like DXA and MRI, as well as blood tests measuring bone formation and resorption markers. During the study, participants undergo assessments at baseline, 3 months, and 6 months, including body composition scans, thigh MRI, and blood tests for various bone and muscle-related markers. The study tracks changes in fat-free mass, muscle mass, and bone density to understand the effects of tirzepatide and lifestyle interventions. Safety and adherence to the lifestyle toolkit will be monitored throughout the trial, which is expected to continue until May 2027.
CONDITIONS
Brief Title
GLP-1R Actions on Muscle and the Skeleton
Who Can Participate
Age: 18Years - 50Years
All Genders
Eligibility Criteria
You may qualify if you...
- BMI between 30 and 40 kg/m2 (inclusive)
- Age between 18 and 50 years (inclusive)
- Non-Hispanic Black males and females enrolled at PBRC
- Rural males and females enrolled at MaineHealth
- Female participants must be premenopausal
- Females must have had their last menstrual period less than 60 days before screening
- Females must not have menopausal vasomotor symptoms
- All participants must be able to use the Lifestyle Toolkit as prescribed for the intervention group
You will not qualify if you...
- Age over 50 years
- Menopausal females
- Use of systemic corticosteroids or other drugs known to cause muscle or bone loss
- Use of medications that alter weight status
- Contraindications to tirzepatide as per package insert
- History of cancer except non-melanoma skin cancer
- Known osteoporosis or current osteoporosis treatments
- Uncontrolled thyroid or parathyroid disease
- Significant blood, kidney, liver disease, or diabetes
- Females of childbearing potential not agreeing to effective contraception during the study
- Use of injectable contraceptives like Depo-Provera
- Inability to follow the Lifestyle Toolkit as prescribed
- Clinical depression with PHQ-9 score 15 or higher
- Unable to provide consent or under 18 years old
- Pregnancy
- Incarceration
- Contraindications to MRI (e.g., metallic implants, claustrophobia, weight over 500 pounds)
- Vitamin D level below 15 ng/ml
- Significant EKG abnormalities posing risk for weight management therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5 months
Participants receive treatment with Tirzepatide for 5 months, with some also using a lifestyle toolkit including protein shakes and resistance-based exercise.
Visits at baseline, month 1, month 3, and month 6 for assessments including DXA imaging and MRI scans
Trial Site Locations
Total: 1 location
1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
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Research Team
R
Robert L Dubin, MD
S
Seaneen Hebert, MS
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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Published Research Related To This Trial
Healthy Weight Loss Maintenance with Exercise, Liraglutide, or Both Combined.
Julie R Lundgren, Charlotte Janus, Simon B K Jensen...
https://pubmed.ncbi.nlm.nih.gov/33951361Tirzepatide Once Weekly for the Treatment of Obesity.
Ania M Jastreboff, Louis J Aronne, Nadia N Ahmad...
https://pubmed.ncbi.nlm.nih.gov/35658024Glucagon-like peptide-1 receptor agonist-based agents and weight loss composition: Filling the gaps.
Robert L Dubin, Steven B Heymsfield, Eric Ravussin...
https://pubmed.ncbi.nlm.nih.gov/39344838