Effects of Long-Acting GLP-1 (Glucagon-like Peptide-1) or Dual Incretin (GLP-1 and GIP [Glucose-dependent Insulinotropic Peptide]) Modulation on Gastric Motor Functions

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06801015
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    Both interventions are approved by FDA for the treatment of obesity and are administered by subcutaneous injection once per week
  • Tirzepatide — DRUG
    Both interventions are approved by FDA for the treatment of obesity and are administered by subcutaneous injection once per week
  • Placebo — DRUG
    Placebo administered by subcutaneous injection once per week.

Study Details

The purpose of this study is to compare effects of weekly SQ semaglutide 2.4mg SQ, SQ tirzepatide 10mg, and placebo administered for 24 weeks on GES measured repeatedly at baseline, 16 weeks, 24 weeks, 28 weeks, 4 weeks after stopping the medication, and accommodation and satiation at 24 weeks compared to baseline.

Key Dates

Start date
Oct 1, 2025
Status verified
Dec 2025
Primary completion
Jan 31, 2028
Completion
Mar 31, 2028

Study Design

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

Arms

  • Experimental: semaglutide
    Administered by subcutaneous injection once per week in accordance with FDA approved escalation as well as maintenance treatment
  • Experimental: Tirzepatide
    Administered by subcutaneous injection once per week in accordance with FDA approved escalation as well as maintenance treatment
  • Placebo Comparator: placebo
    Administered by subcutaneous injection once per week

Primary Outcome Measure

Gastric emptying of solids T1/2 min, that is time for half meal to empty from stomach [ Time Frame: Measurement at baseline, after 16 and 24 weeks' treatment, and at 28 weeks (off treatment for 4 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Rochester, MN

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Mayo Clinic in Rochester· Rochester, MN

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