GLP-1R Actions on Muscle and the Skeleton

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Pennington Biomedical Research Center
Study ID
NCT07154719
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    GLP-1 based treatment for obesity
  • Lifestyle toolkit — BEHAVIORAL
    2 ABBOTT protein shakes daily and resistance-based exercise x 3 days per week.

Study Details

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.

Key Dates

First listed
Sep 4, 2025
Start date
Oct 9, 2025
Status verified
Aug 2026
Primary completion
Feb 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

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. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Pennington Biomedical Research CenterBaton RougeLouisiana70808-
MaineHealth Center for Clinical and Translational ScienceScarboroughMaine04074
Irwin Brodsky, MD, MPH
[email protected]
207-396-7700
Sarah Eastman
[email protected]
207-396-8138
Irwin Brodsky, MD, MPH (PRINCIPAL_INVESTIGATOR)

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Pennington Biomedical Research Center· Baton Rouge, LAMaineHealth Center for Clinical and Translational Science· Scarborough, ME

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