A Study of Tirzepatide in Overweight and Very Overweight Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: Placebo; Drug: Liraglutide; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04311411

I8F-MC-GPHH (Other Identifier)

17223

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 3 patient groups, including a placebo group

Tirzepatide

Experimental group

Description:

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.

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Liraglutide

Active Comparator group

Description:

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.

Treatment:

Drug: Liraglutide