A Study of Tirzepatide in Overweight and Very Overweight Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-24

Study Completion Date

2022-12-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Tirzepatide and placebo dosing are double-blind. Liraglutide dosing is open label.

Study Groups

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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.

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC.

Placebo

Participants received placebo administered into the SC tissue of the abdominal wall.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC.

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.

Group Type ACTIVE_COMPARATOR

Liraglutide

Intervention Type DRUG

Administered SC.

Interventions

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Tirzepatide

Administered SC.

Intervention Type DRUG

Placebo

Administered SC.

Intervention Type DRUG

Liraglutide

Administered SC.

Intervention Type DRUG

Other Intervention Names

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LY3298176

Eligibility Criteria

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Inclusion Criteria

* Have stable body weight for the past 1 month prior to screening
* Have a body mass index (BMI) between 27 to 50 kilograms per meter squared (kg/m²), inclusive at screening
* Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
* Women must not be pregnant or breastfeeding

Exclusion Criteria

* Have undergone or plan to undergo gastric bypass or bariatric surgery
* Have claustrophobia or have ferromagnetic implants that can interfere with completion of fMRI measurements
* Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study
* Unwilling to comply with smoking and alcohol restrictions during the study
* Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
* Have a diagnosis of type 2 diabetes

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No