Indexing hint: Randomized controlled trial · 2022
Tirzepatide Once Weekly for the Treatment of Obesity.
Jastreboff et al. 2022The New England journal of medicinecited by 2,802
PMID 35658024DOI 10.1056/nejmoa2206038PUB-35658024
Trial · Interventional
RecruitingPhase 4Registry dataShort name GRAMS
United States
1 trial · 1 ongoing
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
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.
Outcomes the sponsor listed as primary.
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.
DXA (Dual energy Xray absorptiometry)
MRI (thigh) without contrast
Time frame · Month 1 (baseline), month 3, month 6 (final visit)
To assess for muscle quality (% of skeletal muscle to intermuscular fat)
Osteocalcin
Time frame · Month 1 (baseline), month 3, month 6 (final visit)
Blood draw, metabolism biomarker
Irisin
Time frame · Month 1 (baseline), month 3, month 6 (final visit)
Blood draw, bone health biomarker
Procollagen 1 N-terminal peptide (P1NP)
Time frame · Month 1 (baseline), month 3, and month 6 (final visit)
Blood draw, bone health biomarker
C-Terminal Telopeptide of type I collagen (CTX-1)
Time frame · Month 1 (baseline), month 3, month 6 (final visit)
Blood draw, bone health biomarker
Insulin-like Growth Factor 1 (IGF-1)
Time frame · Month 1 (baseline), month 3, month 6 (final visit)
Blood draw, bone health biomarker
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
2 studies on this page
Indexing hint: Randomized controlled trial · 2022
Jastreboff et al. 2022The New England journal of medicinecited by 2,802
PMID 35658024DOI 10.1056/nejmoa2206038PUB-35658024
Indexing hint: Randomized controlled trial · 2021
Lundgren et al. 2021The New England journal of medicinecited by 417
PMID 33951361DOI 10.1056/nejmoa2028198PUB-33951361
1 study on this page
Indexing hint: Review · 2024
Dubin et al. 2024Diabetes, obesity & metabolismcited by 36
PMID 39344838DOI 10.1111/dom.15913PUB-39344838
Who could join, as posted.
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