Osteoporosis Clinical Trials

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GLP-1R Actions on Muscle and the Skeleton

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
United States
Louisiana
Pennington Biomedical Research Center
RECRUITING
Baton Rouge
Contact Information
Primary
Robert L Dubin, MD
Robert.Dubin@pbrc.edu
9417862130
Backup
Seaneen Hebert, MS
Seaneen.Hebert@pbrc.edu
2257632500
Time Frame
Start Date: 2025-10-09
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 50
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Pennington Biomedical Research Center
Collaborators: National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov