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

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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

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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