A Study of Tirzepatide in Overweight and Very Overweight Participants

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Eli Lilly and Company
Study ID
NCT04311411
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The main purpose of this study is to measure the effect of tirzepatide on food intake in participants who are overweight or very overweight. The study will also use imaging to learn more about how tirzepatide affects specific parts of the brain. The effect of tirzepatide on appetite will also be studied. The study will last up to about four months and will include up to 14 visits to the study center.

Key Dates

Start date
Aug 24, 2020
Status verified
May 2024
Primary completion
Dec 16, 2022
Completion
Dec 16, 2022

Study Design

Enrollment
114 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Tirzepatide
    Participants received tirzepatide 5 milligrams (mg) once a week (QW) for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the subcutaneous (SC) tissue of the abdominal wall.
  • Placebo Comparator: Placebo
    Participants received placebo administered into the SC tissue of the abdominal wall.
  • Active Comparator: Liraglutide
    Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg once daily (QD) for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall.

Primary Outcome Measure

Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3 [ Time Frame: Baseline, Week 3 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Indiana University School of MedicineIndianapolisIndiana46202-
Pennington Biomedical Research CenterBaton RougeLouisiana70808-
Johns Hopkins University School of MedicineBaltimoreMaryland21287-

Find similar trials in Indianapolis, IN

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Indiana University School of Medicine· Indianapolis, INPennington Biomedical Research Center· Baton Rouge, LAJohns Hopkins University School of Medicine· Baltimore, MD

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