A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide

Lilly

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Placebo; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04081337

17092

I8F-MC-GPGU (Other Identifier)

Details and patient eligibility

About

This is a study of tirzepatide in participants with obesity. The main purpose is to learn more about how tirzepatide affects the number of calories participants burn and the amount of food they eat. The study lasted for 28 weeks and will include about 21 visits to the study center.

Enrollment: 55 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have body mass index of 30 to 45 kilograms per square meter (kg/m²), inclusive
• Have a stable body weight in the past 1 month prior to screening
• Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

Exclusion criteria

• Have undergone gastric bypass or bariatric surgery
• Have a diagnosis of type 2 diabetes
• Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
• Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
• Have any lifetime history of a suicide attempt
• Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at screening
• Positive responses to selected items on the Columbia Suicide Severity Rating Scale (C-SSRS)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo once weekly (QW) by Subcutaneous (SC) injection.

Treatment:

Drug: Placebo

15 Milligram (mg) Tirzepatide

Experimental group

Description:

Participants received 15 mg of tirzepatide QW by SC injection.

Treatment:

Drug: Tirzepatide